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Showing posts with label TMS. Show all posts
Showing posts with label TMS. Show all posts

Thursday, September 17, 2015

Class-Action Lawsuit Filed Against Cigna for Allegedly Denying Depression Treatment

Class-Action Lawsuit Filed Against Cigna for Allegedly Denying Depression Treatment

Case Raises Questions of Bias Regarding Independent Review Organizations

By Marketwired .

September 9, 2015 08:00 AM EDT

 

LOS ANGELES, CA -- (Marketwired) -- 09/09/15 -- A class-action lawsuit has been filed against Cigna by Psych-Appeal, Inc., in conjunction with Zuckerman Spaeder LLP, on behalf of mental health patients suffering from depression. The federal lawsuit alleges Cigna has categorically refused to cover Transcranial Magnetic Stimulation (TMS), a safe and effective treatment approved by the U.S. Food and Drug Administration.

"Although Medicare and numerous commercial insurers routinely cover TMS, Cigna has unjustifiably categorized this treatment as 'experimental and investigational,'" said Brian Hufford, partner at Zuckerman Spaeder LLP. "By denying coverage for TMS and restricting patients from receiving potentially lifesaving treatment, Cigna is improperly elevating its own interests above the welfare of its members."

The suit involves a 61-year-old woman who has tried multiple treatments for severe depression. In 2008, the FDA cleared TMS for patients who have failed to respond to psychotropic medications. TMS, unlike electroshock therapy, is performed on an outpatient basis without sedation and does not typically result in side effects such as memory loss.

The complaint also alleges that MCMC, LLC, an independent review organization directly contracted with Cigna to evaluate external appeals of the company's TMS denials, rubber-stamps the insurer by relying on outdated clinical research.

"In California alone, at least 75 external appeals to other independent review organizations have recognized TMS as a valid evidence-based treatment for depression since 2011," said Meiram Bendat, mental health attorney and founder of Psych-Appeal, Inc. "We expect this case to highlight the conflicts of interest that independent review organizations have when they are allowed to contract directly with insurers to evaluate claim denials."

On Sept. 3, 2015, Psych-Appeal, Inc. and Zuckerman Spaeder LLP filed a similar class action complaint against Aetna and MCMC.

Interested parties may contact Meiram Bendat at mbendat@psych-appeal.com or Brian Hufford at dbhufford@zuckerman.com.

About Psych-Appeal, Inc.
Los Angeles-based Psych-Appeal, Inc. is a law firm exclusively dedicated to mental health insurance claims, advocating on behalf of patients, clinicians and treatment facilities to overcome insurer denials of treatment. For more information, visit www.psych-appeal.com.

Contact:
Chantal Allan
310-598-3690 x.201
Email Contact

http://news.sys-con.com/node/3447654

Saturday, December 20, 2014

Transcranial Magnetic Stimulation: What Is It and Who Needs It?

Transcranial Magnetic Stimulation: What Is It and Who Needs It?

TMS uses magnetic pulses to electrically stimulate nerve cells in the brain and relieve symptoms of depression.

A silhouetted sad person is pictured.

Though TMS can help to lessen the symptoms of depression, not all patients respond to the treatment.

By Kirstin Fawcett Dec. 15, 2014 | 11:58 a.m. EST + More

 

By the time she was 61, Martha Rhodes had spent decades battling intractable depression. Diagnosis: treatment-resistant major depressive disorder. She’d tried a variety of medications to no avail; most were ineffective or caused nausea, diarrhea, weight gain and mood swings. During one particularly low evening in 2009, she attempted suicide. And every morning when she awoke, she experienced what she describes as “an emotional nausea – it was like this feeling of, ‘Why am I still here? Why do I have to be alive?’” 

But four years ago, Rhodes, now 65, of Danbury, Connecticut, underwent a procedure she says saved her life: repetitive transcranial magnetic stimulation, which uses magnetic pulses to electrically stimulate nerve cells in the brain and is used by doctors to relieve symptoms of depression. 

“My feelings of hopelessness, wishing I were dead and that life wasn’t worth living – all of that went away,” recalls Rhodes, who chronicled her experience with TMS in her 2013 book “3,000 Pulses Later.” Rhodes says she shares her story with others to demystify the treatment – which is often misunderstood by both patients and doctors, though it's increasingly used by medical practitioners nationwide.

What Is TMS?

TMS was first developed in the early 1980s, but it was only approved by the Food and Drug Administration in 2008 for patients like Rhodes, who’ve unsuccessfully tried one or more medications for their treatment-resistant depression and want to explore other options. That's according to Mark George, a professor at the Medical University of South Carolina in Charleston.

Depression, George says, is a disease that stems from a lack of activity in certain parts of the brain – specifically the prefrontal cortex, the region  right above the eyes that helps regulate emotions. TMS is a technology that allows doctors to noninvasively stimulate that part of the brain and “exercise it back into health.” 

During TMS, George says, a doctor takes a hand-held electromagnetic coil and holds it up to the front left side of the patient’s skull for nearly 40 minutes. The electricity creates a powerful magnetic field, which passes into the brain and causes neurons to fire electrical impulses. In turn, the electrical impulses encourage a chemical reaction that, over time, helps lift mood.

TMS is different from other brain-stimulation therapies, like electroconvulsive therapy. During ECT, patients receive anesthesia and are stimulated across the scalp with a very small electrical current. The current induces a short brain seizure, which produces changes in the brain’s functioning and chemistry. TMS, on the other hand, is a nonconvulsive procedure; patients don’t have a seizure, and they are awake and alert the entire time. There are also no cognitive side effects or memory loss in TMS, which physicians say are common – although benign – in patients who undergo ECT. 

“But in some ways, the two procedures are similar,” George says. “We're trying to reset and wake up connections in the brain that aren't really working well.” 

What Is It Like?

Five days a week, Rhodes, a former advertising executive, traveled to Hartford Hospital’s Institute of Living in Hartford, Connecticut, where she sat in a comfortable reclining chair with a magnetic coil affixed to the side of her head delivering 3,000 pulses to her prefrontal cortex. She was able to watch TV, read, receive visitors and relax. After the day’s procedure was finished, she drove herself home. This lasted six weeks, with a total of 30 sessions – a standard duration, doctors say, for a course of TMS. (Some patients decide to get TMS for shorter or longer periods – say, four or seven weeks – depending on their needs.)

Rhodes compared the sensation of having electrical pulses delivered to the side of her head in the form of four, 10-pulse bursts in a row (with a rest period of 26 seconds between each interval) to a woodpecker pecking her skull. She also had to wear earplugs to drown out the noise of the machine, which makes a loud tapping sound.

The treatment was “jarring” at first, but eventually Rhodes got used to it. Then about four weeks in, after her 19th or 20th daily session, she “felt this lightness,” she remembers. “All of the sudden, this cloud was gone.” Her depression had finally lifted – and right on schedule, according to doctors, who say that patients often experience relief from TMS within two to four weeks. 

What Are the Side Effects?

There’s a very low risk of patients experiencing a seizure in TMS, says Irving Reti, an associate professor of psychiatry at Johns Hopkins University School of Medicine and director of the Brain Stimulation Program at Johns Hopkins Hospital. Side effects typically include a minor headache and localized pain underneath the magnetic coil. 

Another possible side effect, says Lindsey Carpenter, chief of the Mood Disorders Program and the Neuromodulation Clinic at Butler Hospital in Providence, Rhode Island, is a twitching or vibrating sensation around the face, cheek or scalp.

Rhodes says she didn’t experience any of the above symptoms, although she did occasionally take Tylenol to ward off potential pain. 

Who Gets TMS?

Research suggests ECT is a more effective treatment than TMS for relieving severe depression. Therefore, many patients choose ECT over TMS if they’ve tried multiple medications or therapies to no avail, or if they’re suicidal, psychotic or catatonic.

However, George says, some patients with treatment-resistant depression are reluctant to receive ECT – typically administered three times a week until a patient's depression is relieved, which can take anywhere from six to 12 sessions. They worry about memory loss, or they don’t want to invest the time. (Since ECT requires anesthesia, patients are generally out of commission on treatment days, and must rely on rides to and from appointments.) TMS, George points out, is also time-consuming, but it can be integrated into a daily routine. A person with depression that’s bad but not life-threatening might be a good candidate for TMS if they’ve already explored pharmaceutical options. If TMS doesn’t work, they might opt for ECT later down the line – a decision Rhodes says she might've made had the former treatment not worked for her.

Additionally, Carpenter points out, many psychiatric patients have multiple conditions or disorders, and therefore aren't good candidates for anesthesia. “We use TMS for a lot of patients that otherwise would’ve gone straight to ECT if they were healthier,” she says. 

On the other side, there are people who aren’t eligible to receive TMS, Reti says. Those with a history of seizures shouldn’t have it, as well as individuals who have metal in and around their head – say, a metal plate. (Braces and fillings are OK.)

Does TMS Work for Everyone?

Unlike Rhodes, not everyone in the medical community is convinced of TMS’s effectiveness. The National Institute of Mental Health calls the results of past clinical studies “mixed,” and the American Psychiatric Association says TMS offers patients “relatively small to moderate benefits.” Until recently, many insurance companies wouldn’t cover TMS. However, newer studies are showing promising remission and response rates among patients, as well as prolonged periods of improvement post-procedure.

George estimates that TMS can help up to one-third of patients achieve remission. And about 50 to 60 percent of patients show some response, he adds, meaning their depression symptoms have lessened. “It’s a pretty effective treatment,” he says.

But physicians warn that not all patients respond to TMS – nor can anyone predict who will respond. And although many insurance companies now cover TMS, some still don’t, and others require prior authorization. Medical assistance programs like Medicaid don't always pay for TMS. And out-of-pocket expenses for six weeks of TMS can total up to $10,000 – a lot for a procedure that might not work. “Unfortunately, that's the case with all our treatments in psychiatry,” Carpenter says. “It's one of the most pressing research questions: Who's going to benefit from a certain type of treatment so you can spare people the time, money and energy?”

Such was the question for Christy Moceri, a 31-year-old grant writer from Gainesville, Florida, who underwent TMS in July 2011. Like Rhodes, Moceri was a prime candidate for TMS – she’d experienced depression for years and encountered numerous side effects with medications.

“There isn’t a ton of research on TMS, but what my husband and I found was promising, and we could see that insurance companies were becoming more likely to cover it,” Moceri says. “We knew about the firmly established effectiveness of treatments like ECT and this seemed to be based on a similar theory. So we decided to take a gamble.” 

Initially, Moceri says, TMS made her feel better almost immediately. “Significantly, markedly better, with no side effects,” she says. “Everyone on staff [at the clinic] was very encouraged by my progress.” 

But her success didn’t last: Moceri once again slipped into depression and didn’t want to pay for follow-up treatments.

Additionally, doctors note, TMS patients often need a “top off” of sorts – brief booster treatments in case depressive symptoms return. Fortunately, Carpenter says, most TMS patients respond well to these maintenance TMS sessions. “If it got you better once, it’s extremely likely to get you better again,” she says, and much more quickly than the first go-around. Nevertheless, researchers still don’t know how to predict how long the benefits of TMS will last until a patient gets sick again.           

Rhodes doesn’t take antidepressants anymore, but she receives maintenance TMS once a month. Although it helps manage her depression, she says, serious depressive illnesses like hers are lifelong and recurring. “TMS is a tool, not a cure,” she says. The year following her first TMS treatment, Rhodes had several “tune up” treatments. She later experienced a depressive relapse and countered it with another 10 TMS sessions. If she goes too long without receiving it, she says, she experiences obsessive thought patterns, weepiness and agitation.

Overall, Rhodes says her life has been restored – even if her depression never quite leaves her side. “What I have achieved with this therapy,” she says, “is a sense of vitality – a sense of wanting to be alive.”

http://health.usnews.com/health-news/patient-advice/articles/2014/12/15/transcranial-magnetic-stimulation-what-is-it-and-who-needs-it

Tuesday, November 18, 2014

Magnetic therapy gains favor in battling depression

Magnetic therapy gains favor in battling depression

Neuropsychiatrist Dami Salami (left), medical director of the repetitive transcranial magnetic stimulation program at Froedtert & the Medical College of Wisconsin, says rTMS has been successful in treating depression. With Salami is Yagna Pathak, an rTMS technologist and researcher.

Michael Sears
Neuropsychiatrist Dami Salami (left), medical director of the repetitive transcranial magnetic stimulation program at Froedtert & the Medical College of Wisconsin, says rTMS has been successful in treating depression. With Salami is Yagna Pathak, an rTMS technologist and researcher.

By John Keilman, Chicago Tribune

Nov. 18, 2014 10:07 a.m.

 

Chicago — A machine that sends magnetic pulses into a patient's brain has become the new frontier of depression treatment, promising to ease symptoms for those who have found little relief from medication or talk therapy.

The treatment, known as transcranial magnetic stimulation, or TMS, is part of a wave of technologies that attempt to jolt the brain back to health. It caught on quickly after the Food and Drug Administration approved its use six years ago.

A form of it called repetitive transcranial magnetic stimulation, or rTMS, is being used with success at Froedtert & the Medical College of Wisconsin, according to neuropsychiatrist Dami Salami, an assistant professor of psychiatry and behavioral medicine at the Medical College of Wisconsin. Salami is medical director of the Froedtert & Medical College rTMS program.

"It's very promising, and I suspect it's going to be a major tool going forward," he said, noting that there's "limited awareness of this new treatment option." It has been used at Froedtert & the Medical College since 2011.

Though some have questioned the technology's effectiveness, more insurance companies are starting to cover it, helping with a price tag that can reach $10,000 for six weeks of treatment. It's covered by Medicare, Salami noted.

"What this does is raises (your mood) up to normal," a 55-year-old woman from the western Chicago suburbs said after finishing a treatment session at Linden Oaks at Edward in Naperville, Ill. "You can operate."

Stimulative brain therapies have been around for decades, the best known being electroconvulsive therapy, a technique that uses an electric current to cause a seizure. It was portrayed as a mind-erasing menace in the movie "One Flew Over the Cuckoo's Nest," though psychiatrists say the procedure is safe today.

Other methods use implanted devices to send electrical pulses to the vagus nerve — a transmission line that carries messages to the brain's mood center — or to the brain itself. Some studies have found that these techniques help to elevate the moods of people with severe depression.

Mark George, a South Carolina psychiatrist who edits the medical journal Brain Stimulation, said TMS produces similar effects without the need for surgery.

A patient sits in a chair that resembles something from a dentist's office as a device containing the magnetic coil is placed on his head. When it's activated, George said, magnetic pulses penetrate the skull and stimulate nerve cells — the Linden Oaks patient described the sensation as "having a woodpecker sitting on your head" — provoking a therapeutic response.

George acknowledged that the technology doesn't work for everyone. Early studies, which relied on subjects who had been taken off their medications, found that only about 15% saw their depressive symptoms go away.

But later research that allowed subjects to stay on their meds, which George called a more true-to-life test, found that 40% had complete relief from their symptoms, while 60% got at least somewhat better.

Salami says the repetitive TMS he uses involves a brain MRI to identify a specific treatment site, is more targeted than traditional TMS and has been effective in 80% of cases. By contrast, he notes, the response rate for medication is 50% to 60%.

The treatment is especially helpful in what he called resistant cases of depression, defined as those who have not experienced remission of depressive symptoms after at least two treatment modalities — meaning medications and/or therapy.

"It uses magnetic field pulses over a specific period of time," he said of the method used at Froedtert & MCW. "The repetitive nature is key with treatment resistant cases. We can modify the way we deliver treatment, and the treatment parameters ... the strength of treatment parameters. ... We can increase the magnetic field current and frequency, and the band width."

It's not as effective as electroconvulsive therapy, which has full remission rates of around 60%, but George said that treatment requires patients to be anesthetized and is known to cause memory and cognitive problems in some.

TMS, by contrast, requires no sedation, and its biggest complication appears to be discomfort where the magnets are placed on the head.

Salami said rTMS doesn't carry with it the side effects of medications, and patients can return to work or other activities after a treatment session. The treatment has been used for patients with Parkinson's disease and for chronic pain at other centers, he said, and there are ongoing studies looking into its effectiveness in other disorders, including obsessive compulsive disorder.

"It's a highly effective treatment and has only trivial side effects," said physician Jesse Viner, medical director at north suburban Evanston's Yellowbrick psychiatric health care center. "There's no persistent adverse effect. You can have a little bit of a headache or facial pain, but that quickly subsides, and in our experience, by the time people have their third or fourth treatment, they're OK."

The effectiveness of TMS came into question in 2007 when the FDA was considering its use as a depression treatment. The Washington-based advocacy group Public Citizen, which often tangles with the agency over what it considers lax standards for medical devices, claimed the study the FDA relied on was unreliable.

The data at first showed that TMS was not significantly superior to a "sham treatment" that didn't subject patients to the magnetic pulses, the group said: Better results from TMS were evident only when some subjects were removed from the trial, and even then the difference was small.

What's more, the group said, patients receiving TMS knew they were getting something because unlike the sham treatment, the pulses produced a painful sensation.

"Given the small differences we were seeing, that could have been explained by the placebo effect," said physician Michael Carome, director of Public Citizen's health research group.

Physician David Brock of Neuronetics, the Pennsylvania-based company that sought FDA approval for its TMS machines, pointed to a rebuttal by the study's authors that defended their methodology and cited the improvement made by patients who received the treatment. Subsequent research, Brock said, has further demonstrated the effectiveness of the technology.

The FDA decided to allow TMS as a depression treatment, and many Medicare contractors have since covered the service. Though private insurance companies remain split, with companies such as Blue Cross and Blue Shield of Illinois paying for TMS and others declining to do so, more than 100 million people now have coverage for the treatment, Brock said

That has encouraged more health care providers to invest in the machines, which physicians say cost $75,000 to $90,000. But Rad Gharavi, a suburban Oak Park, Ill., psychiatrist who has offered the service for four years, said insurance problems remain.

Coverage begins only after a patient has failed to get better after trying antidepressants. Gharavi said that can force patients to endure the side effects of medications for months.

"That means we are essentially delaying treatment," he said. "TMS can literally take away all the symptoms in six weeks."

It was more complicated than that for the Linden Oaks patient, who has dealt with depression since she was a teenager. She first received the treatment four years ago but comes for follow-up treatments every three months or so when she "can feel the beast creeping up," she said.

"It's apparently very individualized," she said. "There's been a bit of fine-tuning in terms of knowing when to come back for a booster."

Philip Janicak, a psychiatrist who has researched and performed TMS and is now helping Linden Oaks set up its program, said a recent study to which he contributed found that, generally speaking, the effects of the treatment last for a year.

With TMS now firmly established as a depression treatment, Janicak said research is turning to other possible uses, from migraines to Parkinson's disease to post-traumatic stress disorder.

"I see us really at the opening of this era," he said. "There's a lot of things we can do with this technology to help people, and we're just starting to touch the surface of it with depression."

For information on repetitive TMS at Froedtert and the Medical College of Wisconsin, call (414) 955-8952.

Jan Uebelherr of the Journal Sentinel staff contributed to this report.

http://www.jsonline.com/news/health/magnetic-therapy-gains-favor-in-battling-depression-b99380178z1-283055921.html

Friday, October 17, 2014

A patient’s experience with rTMS…

To the readers,

As many of you know I have through the years primarily devoted my efforts toward educating and sharing my knowledge and experiences as it relates to one particular therapy option; VNS Therapy for Depression.

While I continue to do so I am also a strong vocal mental health advocate/activist for any therapy option which safely and reasonably offers the potential for wellness with minimum potential for serious side-effects. One such treatment I have been following has been TMS (Transcranial Magnetic Stimulation). I have been allowed to share some recent correspondence I’ve had with a young woman currently utilizing TMS for her depressive illness. The correspondence is self-explanatory and copied and pasted below.

Herb

 

………………………………………………………………………………………………………………………………………

Paulette (Redacted)
Oct 12 (5 days ago)

to me

Hi Herb,

On the one hand, I wish I had responded to you sooner.  On the other hand, had I been able to, I would not so desperately have needed the treatments.  I have finished my first four weeks out of six weeks of daily treatments; then I will taper from three to two  to once per week.

I was happy to have been considered eligible for the treatments, but I think the treatment is so new, they will qualify anybody just to build a data-base of outcomes.

I was told the chances were only 50% that it would work; then I was given the three strikes against me: the very strong and broad family history; my unspeakably brutal childhood; and the decades I went without treatment.  But I can clearly tell it is working.

In Ohio, rTMS is covered by Medicare and, because I am so very poor, I'm on state QMB - Qualified Medicaid Beneficiary - which picked up the co-pay that would have been around $1500.  I forget how soon, but I will be allowed at least one "tune-up."

I hope this info helps.  Feel free to respond should you like more.

Peace,

Paulette

………………………………………………………………………………………………………………………………………..

Herb <vnsdepression@gmail.com>

Oct 12 (5 days ago)

to Paulette

Dear Paulette,

I am so very glad to hear from you and more importantly I am absolutely thrilled to not only read you were able to obtain the rTMS Therapy but most importantly the fact that you're responding to the treatment.  Bravo for you that you were willing to venture forth and try something new and different.  When Joyce enrolled in the trial for VNS Therapy for Depression we had absolutely no idea of the potential efficacy for depression.  Then again, it wouldn't have made any difference to us as we were desperate and at that point anything was worth a try. 

As it turned out it was the best decision we could have made and the results for Joyce have been nothing less than remarkable.

I hope you continue to improve and that your insurance covers all your costs.

Thanks for letting me know as it makes me feel good to know others are finding relief one way or another.

I wonder if you would allow me to share our email discussions on my blog site as a means to encourage others to not give up while I also endorse patient education and encourage hope. I shall redact any reference to your email address and only leave your first name. Please do let me know and from time to time please update me on how you’re doing.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

……………………………………………………………………………………………………………………………………………

Paulette (Redacted)

6:35 PM (4 hours ago)

to me

Hi Herb,

Thanks for your good wishes.  Yes, you may use my story in your blog.

Peace,

Paulette

Wednesday, October 15, 2014

Magnetic stimulation gains in depression treatment

Magnetic stimulation gains in depression treatment

Transcranial magnetic stimulation offers new treatment for depression

Transcranial magnetic stimulation offers new treatment for depression

By John Keilman, Chicago Tribunecontact the reporter

 

Though some question effectiveness of TMS, more health care providers offering the service

Patient says sensation of TMS electromagnetic pulses like "having a woodpecker sitting on your head"

A machine that sends magnetic pulses into a patient's brain has become the new frontier of depression treatment, promising to ease symptoms for those who have found little relief from medication or talk therapy.

The treatment, known as transcranial magnetic stimulation, or TMS, is part of a wave of technologies that attempt to jolt the brain back to health. It caught on quickly after the Food and Drug Administration approved its use six years ago, and more than 25 Chicago-area hospitals and psychiatrists now use TMS devices.

Though some have questioned the technology's effectiveness, more insurance companies are starting to cover it, helping with a price tag that can reach $10,000 for six weeks of treatment.

"What this does is raises (your mood) up to normal," a 55-year-old woman from the western suburbs said after finishing a treatment session at Linden Oaks at Edward in Naperville. "You can operate."

Magnetic pulses that battle depression

Magnetic pulses that battle depression

by Phil Geib

Stimulative brain therapies have been around for decades, with the best known being electroconvulsive therapy, a technique that uses an electric current to cause a seizure. It was portrayed as a mind-erasing menace in the movie "One Flew Over the Cuckoo's Nest," though psychiatrists say the procedure is safe today.

Other methods use implanted devices to send electrical pulses to the vagus nerve — a transmission line that carries messages to the brain's mood center — or to the brain itself. Some studies have found that these techniques help to elevate the moods of people with severe depression.

Dr. Mark George, a South Carolina psychiatrist who edits the medical journal Brain Stimulation, said TMS produces similar effects without the need for surgery.

 

A patient sits in a chair that resembles something from a dentist's office as a device containing the magnetic coil is placed on his head. When it's activated, George said, magnetic pulses penetrate the skull and stimulate nerve cells — the Linden Oaks patient described the sensation as "having a woodpecker sitting on your head" — provoking a therapeutic response.

George acknowledged that the technology doesn't work for everyone. Early studies, which relied on subjects who had been taken off their medications, found that only about 15 percent saw their depressive symptoms go away.

But later research that allowed subjects to stay on their meds, which George called a more true-to-life test, found that 40 percent had complete relief from their symptoms, while 60 percent got at least somewhat better.

That's not as effective as electroconvulsive therapy, which has full remission rates of around 60 percent, but George said that treatment requires patients to be anesthetized and is known to cause memory and cognitive problems in some.

 

TMS, by contrast, requires no sedation, and its biggest complication appears to be discomfort where the magnets are placed on the head.

"It's a highly effective treatment and has only trivial side effects," said Dr. Jesse Viner, medical director at Evanston's Yellowbrick psychiatric health care center. "There's no persistent adverse effect. You can have a little bit of a headache or facial pain, but that quickly subsides, and in our experience, by the time people have their third or fourth treatment, they're OK."

The effectiveness of TMS came into question in 2007 when the FDA was considering its use as a depression treatment. The Washington-based advocacy group Public Citizen, which often tangles with the agency over what it considers lax standards for medical devices, claimed the study the FDA relied on was unreliable.

The data at first showed that TMS was not significantly superior to a "sham treatment" that didn't subject patients to the magnetic pulses, the group said: Better results from TMS were evident only when some subjects were removed from the trial, and even then the difference was small.

What's more, the group said, patients receiving TMS knew they were getting something because unlike the sham treatment, the pulses produced a painful sensation.

"Given the small differences we were seeing, that could have been explained by the placebo effect," said Dr. Michael Carome, director of Public Citizen's health research group.

Dr. David Brock of Neuronetics, the Pennsylvania-based company that sought FDA approval for its TMS machines, pointed to a rebuttal by the study's authors that defended their methodology and cited the improvement made by patients who received the treatment. Subsequent research, Brock said, has further demonstrated the effectiveness of the technology.

The FDA decided to allow TMS as a depression treatment, and many Medicare contractors have since covered the service. Though private insurance companies remain split, with companies such as Blue Cross and Blue Shield of Illinois paying for TMS and others declining to do so, more than 100 million people now have coverage for the treatment, Brock said

That has encouraged more health care providers to invest in the machines, which doctors said cost $75,000 to $90,000. But Dr. Rad Gharavi, an Oak Park psychiatrist who has offered the service for four years, said insurance problems remain.

Coverage begins only after a patient has failed to get better after trying antidepressants. Gharavi said that can force patients to endure the side effects of medications for months.

"That means we are essentially delaying treatment," he said. "TMS can literally take away all the symptoms in six weeks."

It was more complicated than that for the Linden Oaks patient, who has dealt with depression since she was a teenager. She first received the treatment four years ago but comes for follow-up treatments every three months or so when she "can feel the beast creeping up," she said.

"It's apparently very individualized," she said. "There's been a bit of fine-tuning in terms of knowing when to come back for a booster."

Dr. Philip Janicak, a psychiatrist who has researched and performed TMS and is now helping Linden Oaks set up its program, said a recent study to which he contributed found that, generally speaking, the effects of the treatment last for a year.

With TMS now firmly established as a depression treatment, Janicak said research is turning to other possible uses, from migraines to Parkinson's disease to post-traumatic stress disorder.

"I see us really at the opening of this era," he said. "There's a lot of things we can do with this technology to help people, and we're just starting to touch the surface of it with depression."

jkeilman@tribune.com

Twitter @JohnKeilman

Copyright © 2014, Chicago Tribune

http://www.chicagotribune.com/lifestyles/health/ct-brain-stimulation-met-20141015-story.html

Tuesday, September 30, 2014

Transcranial Magnetic Stimulation Offers Hope for Treatment-Resistant Depression

Therese Borchard
Sanity Break

Help for depression and anxiety

 

Transcranial Magnetic Stimulation Offers Hope for Treatment-Resistant Depression

By Therese Borchard

Published Sep 29, 2014

In December of 2012, Stephanie S. was taking 300 mgs of sertraline (Zoloft), 300 mgs of (bupropion Hcl) Wellbutrin, 300 mgs of trazodone hydrochloride (Desyrel), 200 mgs of risperidone (Risperdal), and 8 mgs of alprazolam (Xanax), but was as depressed as she has ever been. She had also gained 100 pounds as a side effect of all the medications. Having tried a total of 10 different kinds of drugs with no success, her doctor recommended transcranial magnetic stimulation (TMS), a non-invasive procedure that stimulates nerve cells in the brain with short magnetic pulses. A large electromagnetic coil is placed against the scalp which generates focused pulses that pass through the skull and stimulate the cerebral cortex of the brain, a region that regulates mood. The procedure was approved by the FDA in 2008.

She didn’t feel any difference after 11 treatments, but she can vividly remember the morning after her 12th treatment. She explained:

I woke up… I mean WOKE UP!! I felt so light, instead of feeling weighed down. The sun was brighter. My overall feeling was JOY. This was unfamiliar to me, and I loved it. I came downstairs grinning from ear to ear and just looked at my husband. He knew! I just threw my arms around his neck and laughed. The feeling was indescribable. It was NIRVANA!! I felt better than I had felt before my breakdown. It was MAGICAL! I think that was the first time in my life that I felt pure joy!

She continued and finished the 30 treatments.

Dr. Kira Stein, MD, board certified psychiatrist and medical director of West Coast TMS Institute in Sherman Oaks, Los Angeles, is excited about the success she’s had in treating her patients with TMS. She usually does five sessions a week, for a total of 30 sessions; the entire procedure lasts about six to eight weeks, though some patients may need more treatment to respond.

She estimates that about one-third of TMS patients have a full remission and no longer experience depression symptoms.

One-half of TMS patients respond signficantly, where their depression symptoms are improved by at least 50 percent, but do not reach complete remission. The more depressive cycles they have had in their lives, the more difficult it is to treat them in general.

Dr. Stein’s experience is that TMS success rates are higher when TMS is used as an augmentation strategy for patients who have only partially responded to medication, or who cannot tolerate higher medication doses. She usually recommends a person stay on a dose of maintenance antidepressants and finds that some patients need maintenance TMS treatments to stay well.

The treatment is expensive. Dr. Stein says that each session (and on average people usually require 30) run from $300 to $450, a session; however, more and more insurance companies are picking up at least some of the bill.

Stephanie paid $7,450 out of pocket. Her insurance chipped in $7,000 (the total cost was about $14,000).

Stephanie stayed in remission for a year and a half until a cascade of tragic events, including the suicide of her sister, caused a relapse of depressive symptoms. When different kinds of medication again did little to relieve her pain, she decided to do TMS for a second time.

She’s been participating in the online depression support group I moderate on Facebook. About a month ago, I remember a distinct change in the tone of her posts. They went from being desperate to hopeful, from cynical to curious, and from flat to playful.

“What’s the matter with me?” she asked the group. “On the way to my husband’s work, I’m noticing everything for the first time.”

“I think your TMS treatment is working,” I replied.

“Yes!” she said. “I laughed again!!”

She has eight treatments left, and hopes she continues to laugh for a very long time.

Posted in: Depression

6 Comments

http://www.everydayhealth.com/columns/therese-borchard-sanity-break/transcranial-magnetic-stimulation-tms-offers-hope-for-treatment-resistant-depression/

New study reports how TMS treatment works in people with depression

New study reports how TMS treatment works in people with depression

Published on September 30, 2014 at 12:21 PM · No Comments

 

A new study in Biological Psychiatry reports how magnetic stimulation treatment works

On Star Trek, it is easy to take for granted the incredible ability of futuristic doctors to wave small devices over the heads of both humans and aliens, diagnose their problems through evaluating changes in brain activity or chemistry, and then treat behavior problems by selectively stimulating relevant brain circuits.

While that day is a long way off, transcranial magnetic stimulation (TMS) of the left dorsolateral prefrontal cortex does treat symptoms of depression in humans by placing a relatively small device on a person's scalp and stimulating brain circuits. However, relatively little is known about how, exactly, TMS produces these beneficial effects.

Some studies have suggested that TMS may modulate atypical interactions between two large-scale neuronal networks, the frontoparietal central executive network (CEN) and the medial prefrontal-medial parietal default mode network (DMN). These two functional networks play important roles in emotion regulation and cognition.

In order to advance our understanding of the underlying antidepressant mechanisms of TMS, Drs. Conor Liston, Marc Dubin, and their colleagues conducted a longitudinal study to test this hypothesis.

The researchers used functional magnetic resonance imaging in 17 currently depressed patients to measure connectivity in the CEN and DMN networks both before and after a 25-day course of TMS. They also compared the connectivity in the depressed patients with a group of 35 healthy volunteers.

Related Stories

TMS normalized depression-related hyperconnectivity between the subgenual cingulate and medial prefrontal areas of the DMN, but did not alter connectivity in the CEN.

Liston, an Assistant Professor at Weill Cornell Medical College, further details their findings, "We found that connectivity within the DMN and between nodes of the DMN and CEN was elevated in depressed individuals compared to healthy volunteers at baseline and normalized after TMS. Additionally, individuals with greater baseline connectivity with subgenual anterior cingulate cortex - an important target for other antidepressant modalities - were more likely to respond to TMS."

These findings indicate that TMS may act, in part, by selectively regulating network-level connectivity.

Dr. John Krystal, Editor of Biological Psychiatry, comments, "We are a long way from Star Trek, but even the current ability to link brain stimulation treatments for depression to the activity of particular brain circuits strikes me as incredible progress."

Dubin, also an Assistant Professor at Weill Cornell Medical College, adds, "Our findings may inform future efforts to develop personalized strategies for treating depression with TMS based on the connectivity of an individual's default mode network. Further, they may help triage to TMS only those patients most likely to respond."

http://www.news-medical.net/news/20140930/New-study-reports-how-TMS-treatment-works-in-people-with-depression.aspx

Wednesday, September 17, 2014

Response to TMS Sustained in Depression

Medscape Medical News > Psychiatry

Response to TMS Sustained in Depression

Pam Harrison

September 17, 2014

 

 

The final analysis of a study evaluating transcranial magnetic stimulation (TMS) confirms that the majority of patients with resistant depression who respond to TMS in the acute setting continue to have a sustained response for a period of 1 year, an observational trial shows.

David Dunner, MD, director, Center for Anxiety and Depression, Mercer Island, Washington, and colleagues reported that 68% of 257 patients who had received TMS during the acute treatment phase had improved by the end of the 12-month follow-up and that 45% had experienced complete remission at 1 year.

"These are patients with treatment-resistant depression who are difficult to treat, who generally do not get better easily. TMS not only got people better with the usual course of about 30 treatments in the acute treatment phase, but we showed that the benefit was maintained over a 1-year period in the majority of patients who improved," Dr. Dunner told Medscape Medical News.

Courtesy of Neuronetics, Inc.

"So I view TMS as a treatment for people who have a new depression and who have a history of failing 3 or 4 prior treatments for depression, where it is unlikely that the antidepressant is going to work. In that population, I think we get good results, and the results justify the use of TMS and the cost of treatment as well."

The final results of the observational study were published online on September 16 in the Journal of Clinical Psychiatry. Preliminary long-term results were first reported from the American Psychiatric Association meeting in 2013 by Medscape Medical News. The study was supported by Neuronetics Inc.

Long-term Results

As investigators previously reported ( Depress Anxiety. 2012;29:587-596), 62% of patients had achieved symptomatic improvement, and 41% had achieved a complete remission by the end of the acute treatment phase.

http://www.medscape.com/viewarticle/831860

Sunday, September 7, 2014

TMS brings “shock” to science of memory loss

TMS brings “shock” to science of memory loss

By SAMHITA ILANGO
Published: September 4th, 2014
Views: 8 views


UQ.EDU.AU

UQ.EDU.AU

With a few shocks to the brain, scientists have made it possible to never forget a friend’s birthday, lose track of keys or have to deal with uncomfortable encounter of forgetting an acquaintance’s name. A research team at Northwestern University’s Feinberg School of Medicine has used this knowledge for more than just key tracking but for enhancing the retention network of memory-impaired individuals. 

The Transcranial Magnetic Stimulation (TMS) is a noninvasive method to depolarize or hyperpolarize neurons in the brain through electromagnetic induction. Essentially, the treatment will control neurons to be stronger or weaker in an individual. This recent study covers the therapeutic uses of TMS. Joel Voss, assistant professor of medical social sciences at Northwestern University, and his team worked on this project. 

“I am most interested in my research because it has at least some promise for helping individuals with memory impairments,” Voss said. “I’ve spent a lot of time with people after their lives have been essentially destroyed by severe memory impairment, and the desire to figure out some way to improve their lot is what gets me going in the morning.” 

They tested TMS’s impact on memory by understanding the memory-related regions of the brain. Voss and his team tested 16 healthy individuals without memory impairment with an MRI and looked at the treatment’s influence on the regions. This established a standard for proper cognitive function. Afterwards, the same test subjects were brought in for memory tasks over a span of five days with 20 minutes of TMS each time, while an MRI mapped their brain functions. The final analysis of the study revealed that the five days of TMS treatment resulted in the different regions working better together than how they worked at the standard level.

Further analysis sets hopes for this treatment to be able to be used on stroke victims and Alzheimer’s patients.

“I imagine — or rather hope — that in the near future, we devise a superior method for controlling brain function noninvasively,” Voss said. “When I imagine the effects of TMS on neurons, what comes to mind is trying to thread a needle with a shotgun. We will need better if we are to achieve a sophisticated understanding of brain function.”

Chirag Mehra, a neurodevelopment research fellow at the Kennedy Krieger Institute, gave his input on the present and the future of TMS.

“TMS, while stimulating brain regions in this study, is often used to suppress brain regions for research purposes. So far, no long term consequences have been found secondary to this suppression — the suppression ends when the TMS probe is removed,” Mehra said.

He further discussed the prospects of this treatment.

“Perhaps in the future we could apply TMS to treating psychiatric and neurological disorders. For this, we might need to create a much smaller TMS device that remains in our bodies, providing stimulation — intermittently or continuously — on a long term basis, analogous to a pacemaker used to treat cardiac arrhythmias.” 

With the speed at which current neuroscience advancements are occurring, the next 50 years are unpredictable.

“Honestly, advancement is such a moving target that it is impossible to predict very far into the future, much like the weather,” Voss said.

http://www.jhunewsletter.com/2014/09/04/tms-brings-shock-to-science-of-memory-loss-53971/

Saturday, September 6, 2014

Magnet therapy zaps depression

Magnet therapy zaps depression

Frank Gluck, (Fort Myers, Fla.) News-Press8:55 p.m. EDT September 4, 2014

depressionmagnets01.jpg

Jessica Marra, a transcranial magnetic stimulation technician for Dr. Robert Pollack, prepares patient Kimberly Depaz for a treatment. Transcranial magnetic stimulation is used to treat patients for depression by placing a magnetic coil on the scalp that targets the cortex that controls mood.(Photo: Andrew West/The News-Press )

Kimberly Depaz experienced the first signs of depression when she was 5 years old, mostly as feelings of being "really down" and different from everyone else.

Throughout her adult life, she tried every medication and anti-depressant under the sun — Prozac, Zoloft, Wellbutrin and a variety of anti-anxiety medications that provided little more than side effects.

The depression, and even detailed suicidal thoughts, never went away.

Then her Fort Myers psychiatrist offered her a seemingly novel treatment to go along with her counseling: employing high-powered magnets to stimulate the region of her brain that governs mood.

"I have noticed a difference. I would say that I feel more alive," said Depaz, 51. "I'm really happy this is happening, and I'm real optimistic. It was my last, honest to God, last resort."

The treatment — transcranial magnetic stimulation — was approved by the Food and Drug Administration in 2008 for the treatment of patients with medication-resistant depression. The FDA cleared it for use in migraines in December.

Researchers are now probing its efficacy in other disorders, such as anxiety and post-traumatic stress disorder. Other studies suggest it may help with memory.

Regulatory approval has led to a growing number of psychiatric clinics offering the treatment to patients who have otherwise found no relief.

Psychiatric Associates of Southwest Florida in south Fort Myers began offering it in August. Depaz is its first patient.

"As a process, it's probably the most magnificent aspect of the treatment of patients that I've seen in all of my, almost half century (in practice)," said Dr. Robert Pollack, CEO of the clinic and Depaz's psychiatrist. "The living proof is how many people are getting it, how many people are getting better."

Many insurers do not cover the procedure, reflecting the uncertainty the medical community still has about the procedure. And others will pay only on a case-by-case basis. For those uninsured, the price is a steep one: A seven-week course of treatment might run as high as $15,000.

Family Psychiatry, another Fort Myers psychiatric practice, has offered the treatment since April 2013. About a dozen patients have received treatment since then, said Jonathan Hart, the clinic's TMS coordinator.

"It's not a lot because, frankly, it's limited by insurance coverage," Hart said. "But we've had a lot of success stories."

Hart said clinic patients have mostly shown at least some improvement since undergoing treatment. Just under half have had their depression go into remission, he said.

Depaz said she usually feels the fog of her depression lift shortly after the treatment.

"Just clearer, is the best way I can describe," she said. "A lot clearer."

How it works

Magnets generate a directed, pulsed magnetic field — similar to an MRI in strength — to the prefrontal cortex, the front part of the brain behind the forehead. The magnetic fields induce small electrical currents, which encourage a mood-lifting chemical reaction in the brain.

The treatment is daily, for four to six weeks. If the patient improves enough, the treatment is then provided as a periodic booster.

Unlike electro-convulsive therapy, patients don't need sedation and/or anesthesia while undergoing the procedure. It also does not produce the minor memory loss that can come with the shock treatment.

depressionmagnetics02.jpg

Depaz undergoes treatment at Dr. Robert Pollack’s office in Fort Myers.She says she has felt the difference since starting the treatment. (Photo: Andrew West/The News-Press )

Patients are seated on what looks like a dental chair. A technician straps their heads in place to prevent movement, and then attaches magnets to their heads. Patients may read or watch TV while undergoing the procedure, but they may not sleep.

The room is dimly lit, and extra noise is avoided to minimize patient anxiety. Ten-pulse bursts are delivered each second, for four seconds at a time, at intervals of 26 seconds. The whole process lasts 37 minutes and 30 seconds.

Patients and technicians wear ear plugs as the machine emits a sound of rapid knocks, a sound reminiscent of a woodpecker. Depaz likened the sensation of electromagnetic pulses to a hard flicking on the same spot of her skull, over and over.

"Initially, it seemed a bit painful. But it wasn't like, 'Oh, my gosh, I can't take this!' Nothing like that," she said.

Doubts remain

Despite regulatory approval and studies suggesting the treatment may help patients with depression resistant to medication, not everyone in the psychiatric community is convinced magnetic stimulation of the brain works.

They say not enough studies have proven its efficacy, and that many of those done were not done rigorously enough. And these critics worry increased marketing of this treatment could detract patients from effective medications and, in cases of particularly hard-to-treat cases, the current gold standard therapy — electro-convulsive (or "electro-shock") therapy.

Fort Myers psychiatrist and researcher Frederick Schaerf said he is a TMS skeptic and even doubts the concept of "treatment-resistant" depression. He said such patients likely have not found the right medication regimen.

"I don't see its value as a treatment," Schaerf said. "There are other ways to treat patients with pharmacology."

The National Institute of Mental Health describes the treatment as effective for some patients, but notes that studies of its efficacy have been "mixed." The American Psychiatric Association's guidelines for depression treatment states the procedure conveys "relatively small to moderate benefits."

Pollack dismissed critics of the treatment and compared TMS skeptics to those who initially questioned the benefits of anti-depressants. He said the proof is in the growing body of evidence that the treatment can help certain patients.

"There is skepticism always in anything that you do. That's just the way it is," he said. "I'll stand by anything I see data on."

http://www.usatoday.com/story/news/nation/2014/09/04/magnet-therapy-depression/15101705/

Neurostimulation for Mood Disorders

Neurostimulation for Mood Disorders

September 05, 2014 | US Psychiatric & Mental Health Congress 2014, Electroconvulsive Therapy, Mood Disorders, Transcranial Magnetic Stimulation

By Scott T. Aaronson, MD

Q&A

We have asked Dr Scott Aaronson to answer questions on neurostimulation as it relates to the treatment of mood disorders. He is speaking at this year’s PsychCongress in a presentation titled “Neurostimulation in the Treatment of Mood Disorders.” Dr Aaronson is Clinical Associate Professor in Psychiatry at the University of Maryland School of Medicine and Director of Clinical Research Programs and TMS Services at the Sheppard Pratt Health System in Baltimore, Maryland.

Q: What is neurostimulation and why do we need it?

A. Neurostimulation is a modulation of the central or peripheral nervous system by electrical or magnetic impulses. This is commonly used in neurosurgery and neurology for a variety of applications, including pain management, hearing and visual prostheses, and control of Parkinsonism. There is a long history of psychiatric use related to electroconvulsive therapy (ECT), but more recently, devices providing vagus nerve stimulation (VNS) and transcranial magnetic stimulation (TMS) have both been cleared by the Federal Drug Administration (FDA) for use in depression. Several other devices are currently in the process of review by the FDA or undergoing clinical trials.

There is a tendency to look at somatic therapies for depression being exclusively through neurochemicals, but the brain is as much electrical as it is chemical. After 4 decades of antidepressant drug development, we have not moved much beyond the monoamine hypothesis. We have drugs that can effect serotonin, norepinephrine, and—to a lesser extent—dopamine. Many other neurotransmitters are involved with mood disorders, but we have no medications yet to target them. We can alter neurochemicals by neurostimulation as well as alter aberrant neuronal activity. Neurostimulation offers a non-systemic somatic approach to depression, often with an improved side effect profile.

Q: What methods of neurostimulation are currently available and how do they work?

A. electroconvulsive therapy (ECT), vagus nerve stimulation (VNS), and transcranial magnetic stimulation (TMS).

ECT

The oldest neurostimulation intervention, ECT has been used since 1938. It has the highest rate of response for treatment resistant depression (TRD) of any somatic intervention, up to 60%. (1)

Treatment involves inducing a generalized seizure, either through unilateral or bilateral electrical stimulation done while the patient is under general anesthesia along with a paralytic agent. The adverse effect burden is quite high and includes the effects of anesthesia, post-ictal confusion, and short term memory loss. There is a high frequency of relapse with 65% of successfully treated patients ill again within 6 months. (2) Newer techniques under investigation may reduce adverse effects—ultra brief pulse induction, magnetic seizure therapy, or more focally induced seizures. It is more acceptable as an acute treatment than a chronic one. Most insurance will support the use of ECT.

VNS

Treatment involves the implantation of a small battery driven device in the upper chest with electrical leads that are tunneled under the skin and wrapped around the left vagus nerve in the neck. Stimulation is delivered continuously throughout the day for 30 seconds every 5 minutes. This stimulation is carried through the vagus nerve into the brain and has an effect on neurotransmitter synthesis and release. Response to this intervention takes up to 6 months to build and continued improvement has been shown over 5 years.

While having FDA approval since 2005, the use of VNS has been severely limited because of the reluctance of insurance carriers, including Medicare, to provide support, claiming that the evidence for its use has not justified the expense. A recent study looked at dosing of VNS and even low doses show efficacy over time. (3) It is hoped that the coming release of new data looking at the efficacy of VNS over 5 years of treatment might encourage a re-evaluation of its use in patients with chronic severe unipolar and bipolar depression.

TMS

The use of TMS has experienced significant growth in its use since its FDA clearance in 2009. TMS involves the use of a rapidly moving magnetic field to induce a small electric current in the left dorsolateral prefrontal cortex of the brain, an area that has decreased activity when patients are depressed. There are now 2 devices cleared by the FDA—the Neuronetics device (since 2009) and a device from Brainsway (since 2013). The latter uses a different magnetic configuration and purports to offer deeper stimulation.

Outcomes studies on the Neuronetics device demonstrate a 58% response rate in normal clinical practice in a population with moderately treatment resistant depression (patients failed an average of 2.5 antidepressants prior to treatment). (4) The Brainsway study has yet to be published, so comparisons are difficult, but the treatment paradigm uses 5 treatments a week for 5 weeks, rather than 6 with TMS and 20 minutes rather than 37.5 minutes of treatment during every session.

Insurers are slowly increasing their support of this intervention, and many companies now have coverage policies. Issues about treatment of bipolar depression and the use of maintenance treatment have yet to be clarified from research studies. Several other devices are in the process of either FDA review or in clinical trials.

Q. Who are the right patients for neurostimulation?

A. ECT candidates are patients who require quick responses due to severity, suicide risk, or psychosis and are usually fully disabled by their depressions. They have often failed several other interventions, including medications and psychotherapy.

Should VNS become a more reliably covered intervention, one of the best populations would be patients with severe illness that has been chronic. In my experience, ECT responders who require maintenance ECT are ideal candidates. Often they can be maintained with VNS and no longer require ECT. As well, VNS has demonstrated efficacy and has FDA approval for use with bipolar depression, often a population that has limited options for treatment.

TMS, in its current format, is likely not as reliable with severe depression as ECT. It probably will work best with moderate to marked depressions. My experience suggests a better response when used in addition to antidepressant medication but it may also be useful in patients who have been intolerant of multiple antidepressant medications given the lack of systemic side effects. TMS is very well tolerated with only a small incidence of mild to moderate headache during the time of stimulation which is usually for only 4 seconds during each 30 seconds of treatment. The main barriers to use are insurance coverage, time commitment (45 minutes, 5 days a week for up to 6 weeks), and availability of equipment which varies by location.

Q. What does the future hold for neurostimulation?

A.Neurostimulation will likely occupy a greater piece of the psychiatric treatment paradigm. It offers effective interventions for people with severe illness and a non-pharmacologic intervention for patients with moderate to marked presentations. New devices in development may permit shorter courses of treatment and even the possibility of home use.

Suggested reading: Cusin C, Doherty DD. Somatic therapies for treatment-resistant depression: ECT, TMS, VNS, DBS. Biol Mood Anxiety Disord. 2012;2:14.

Disclosures

Dr Aaronson reports that he is a consultant for Neuronetics; an investigator for Neuronetics, Cervel Neurotech, and Neosync; and received a research grant from Stanley Medical Research Institute for Transcranial Direct Current Stimulation.

References

1. Kellner CH, Knapp RG, Petrides G, et al. Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE). Arch Gen Psychiatry. 2006;63:1337-1344.

2. Sackheim HA, Haskett RF, Mulsant BH, et al. Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: A randomized controlled trial. JAMA. 2001;285:1299-1307.

3. Aaronson ST, Carpenter LL, Conway CR, et al. Vagus nerve stimulation therapy randomized to different amounts of electrical charge for treatment-resistant depression: acute and chronic effects. Brain Stimul. 2013;6:631-640.

4. Carpenter LL1, Janicak PG, Aaronson ST, et al. Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of acute treatment outcomes in clinical practice. Depress Anxiety. 2012;29:587-596. - See more at: http://www.psychiatrictimes.com/uspc2014/neurostimulation-mood-disorders#sthash.q22xAP3P.dpuf

http://www.psychiatrictimes.com/uspc2014/neurostimulation-mood-disorders

Tuesday, September 23 • 10:15am - 11:45am

Neurostimulation in the Treatment of Mood Disorders

Neurostimulation will continue to provide a novel, nonpharmacologic, somatic treatment for mood disorders and eventually other psychiatric illnesses, including obsessive-compulsive disorder, anxiety disorders, and addictive behaviors. This session will provide an up-to-date overview of developments in the use of transcranial magnetic stimulation, direct current stimulation, and electroconvulsive therapy. Relevant data pertaining to patient selection, treatment outcomes, and possible mechanisms of action will be discussed along with a look at the future of neurostimulation with regard to expanding patient populations and insurance support.

Faculty

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Scott T. Aaronson, MD

Director, Clinical Research Programs, Sheppard Pratt Health System, Baltimore, Maryland; Director, TMS Services, Sheppard Pratt Health System, Baltimore, Maryland | | Scott T. Aaronson, MD, is Director of Clinical Research Programs at Sheppard Pratt Health System in Baltimore, Maryland, where he has been responsible for developing a research program dedicated to the development of medications, devices, and genetic tests for the treatment of illnesses across the spectrum of psychiatric...
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Tuesday September 23, 2014 10:15am - 11:45am
Room 2 - TBA (Rosen Shingle Creek Hotel)

Thursday, September 4, 2014

TMS NeuroHealth Centers Now Accepting Medicare and Reaches Treatment Milestone

TMS NeuroHealth Centers Now Accepting Medicare and Reaches Treatment Milestone

Medicare’s coverage of TMS therapy offers assistance to clients needing depression treatments. TMS NeuroHealth surpasses 10,000 treatments.

 

We are excited to provide Medicare and Blue Cross members with the opportunity to utilize TMS therapy for their battle against Major Depressive Disorder

(PRWEB) September 04, 2014

TMS NeuroHealth Centers, a leading provider of TMS Therapy to patients located in the Washington DC Metro Area, Virginia, and Maryland, is pleased to announce that it is now accepting Medicare in order to make this groundbreaking treatment available to a broader range of patients suffering from Major Depressive Disorder. TMS NeuroHealth Centers, which has been in operation since 2011, has also reached a proud milestone; 10,000 TMS Therapy treatments have been administered since opening.

TMS Therapy is a non-drug, non-invasive, and FDA-cleared medical treatment for patients suffering from depression. It uses highly focused magnetic pulses to gently stimulate the area of the brain that controls mood. This specific area in the prefrontal cortex of the brain is stimulated to release chemical neurotransmitters, relieving the symptoms of depression. Each treatment is approximately a 45 minute outpatient procedure; typically administered five days a week for 4-6 weeks in its acute phase. TMS Therapy is a proven form of treating depression when patients are suffering from side effects of medication and/or have not benefited from antidepressant medication.

Medicare offers competitive coverage for TMS Therapy and we are thrilled that our list of insurance providers is expanding for this depression treatment which also includes Blue Cross and Blue Shield. As part of TMS NeuroHealth Centers’ ongoing dedication to provide top quality care to our patients, we are committed to helping our patients manage the process for reimbursement and discuss options for financing of their TMS therapy.

"We are excited to provide Medicare and Blue Cross members with the opportunity to utilize TMS therapy for their battle against Major Depressive Disorder,” said Bill Leonard, President of TMS NeuroHealth Centers. “TMS is a proven therapy that has benefited thousands and thousands of patients suffering from depression."

TMS NeuroHealth Centers is also very proud that we have now administered over 10,000 treatments to our patients since opening in 2012. "It’s fantastic that we have hit this milestone,” commented Dr. Singh, Medical Director of TMS NeuroHealth Centers in Tysons Corner, VA. “This is an indication that TMS therapy is becoming more accepted as a treatment by the community. We can also see this from the increase in referrals from local psychiatrists”. A contributing factor to reaching this milestone is the fact that 3 out of every 4 patients have had success in reducing or relieving depression symptoms at TMS NeuroHealth Centers and they are sharing their experiences.

As of July, it is easier to get to TMS NeuroHealth Centers Tysons Corner location with the opening of the new Silverline Metro. Spring Hill Station is less than 1 block from the center. By offering a convenient alternative to driving, the Silver Line is expected to transform Tysons, previously an automobile-centric area into a more walkable, bikeable, and livable community. The opening gives more people much easier access to our location and this depression treatment.

About TMS NeuroHealth Centers
TMS NeuroHealth Centers are medical centers dedicated to helping those affected by neurological disorders live better lives. TMS NeuroHealth Centers provide access to the best medical expertise and the latest medical technology in the field of neurology and mental health. The first TMS NeuroHealth Center opened in Tysons Corner (McLean, Virginia) in November, 2011. To find out more, visit http://www.tmsneuro.com.

http://www.prweb.com/releases/2014/09/prweb12141814.htm

Friday, August 1, 2014

Stimulation Device Shows 'Immediate' Impact on Depression

Stimulation Device Shows 'Immediate' Impact on Depression

Pauline Anderson

July 31, 2014

Stimulation with a low-strength electromagnetic field device immediately improves mood in patients with major depressive disorder (MDD) and bipolar disorder (BPD), new research shows.

Results from a randomized, double-blind, sham-controlled study are exciting, especially because the effects were so rapid, lead author Michael L. Rohan, PhD, a physicist at McLean Hospital and Harvard Medical School, Belmont, Massachusetts, told Medscape Medical News.

"I think we have something that is working on the depressed state in either major depressive disorder or bipolar disorder," said Dr. Rohan. "Whether it's more effective in either one of them, we don't know, but it seems to have an immediate effect on the depressed state."

The device holds "great potential" as a clinical tool for psychiatrists, Dr. Rohan added.

The study was published in the August 1 issue of Biological Psychiatry.

Serendipity

The ability of the rapidly oscillating electromagnetic field, called low-field magnetic stimulation (LFMS), to improve mood was discovered "serendipitously" about a decade ago. Researchers who were carrying out experimental MRI scans to assess brain chemistry noticed changes in depressed bipolar patients.

"The subjects started coming out of the baseline scan with improved mood," said Dr. Rohan.

After further research, Dr. Rohan designed and built the portable tabletop device that is now being studied. It consists of a magnetic coil, an amplifier, a waveform generator, and a computer.

The US Food and Drug Administration (FDA) has determined that the device carries a nonsignificant risk.

Dr. Rohan described the LFMS device as being similar in size and shape to "an old-fashioned mailbox." Patients lie on a bed with a padded headrest. The top of their head fits into the device, leaving the rest of their head, including their eyes, exposed.

Compared with transcranial magnetic stimulation (TMS), which uses electromagnetic pulses to stimulate nerve cells, and electroconvulsive therapy (ECT), which induces "small self-repairing seizures," LFMS uses fields that are "at least 100 times weaker," said Dr. Rohan.

Although ECT is "the most successful treatment for depression," it carries a cost, he said. "Patients come in regularly and they get sedated; the treatments are invasive."

High Hopes

The new study included 63 patients aged 18 to 65 years with BPD or MDD who were stably medicated but still symptomatically depressed and who scored 17 or more on the observer-rated 17-item Hamilton Depression Rating Scale (HDRS-17). Most patients took multiple medications throughout the study.

Patients were randomly assigned to receive 20 minutes of active (n = 34) or sham (n = 29) treatment. The inactive device resembled the real one in every way, down to the faint beeping noise it emitted. Neither the patients nor the operators could tell the difference.

"Because the placebo effect is so high in antidepressant studies, we had to be very careful about that sham," stressed Dr. Rohan. "When you have an exciting new device like this, people have high expectations."

Directly before and after the treatment, the mood of the patients was determined with the HDRS-17 and the self-rated visual analogue scale (VAS), which is designed to be responsive to an immediate change in mood.

The study showed that the mean improvements in VAS score were greater for active compared to sham treatment by 0.8 points for BPD (95% confidence interval [CI], -.6 to 2.1; P = .60), 1.6 points for MDD (95% CI, -.4 to 3.6; P = .17), and 1.1 points for the combined sample (95% CI, .2 to 1.9; P = .01).

Mean improvements in HDRS-17 score were greater for LFMS than for sham by 2.5 points for BPD (95% CI, -1.2 to 6.2; P = .34), 3.2 points for MDD (95% CI, -3.3 to 9.6; P = .74), and 3.1 points for the combined sample (95% CI, .5 to 5.8; P = .02).

Dr. Rohan believes that the differences between active and sham treatments were not significant in the individual diagnostic groups because these groups did not have enough participants. He pointed out that the differences did reach significance when the data were combined across groups.

Mood was also assessed with the self-rated Positive and Negative Affect Schedule (PANAS). There was greater improvement in scores among both BPD and MDD patients receiving the active treatment. In this case, the difference was statistically significant not only for the combined sample but also for BPD patients alone, although not for MDD patients alone.

No adverse effects linked to the device were reported.

Potential Mechanisms

There is evidence that rapidly fluctuating magnetic fields that are below the threshold for depolarization can still influence neuronal activity. This, noted the authors, suggests potential cellular mechanisms of action.

Although this is still speculative, Dr. Rohan suggests the device may interact with the nerves in the area of the dendrites where synapses are located.

"The synapses have an electrical function as well as a chemical function, and I suspect that we are interacting with the electrical function in the dendrites."

Because the device seems to provide immediate relief, it might prove useful as a treatment "bridge" in the emergency department, where psychiatric patients may end up in crisis, although the psychiatric community will eventually determine the best application, said Dr. Rohan.

He pointed out that antidepressant medications take several weeks to exert a clinically meaningful improvement in mood and that even ECT requires 2 to 3 treatments per week during a period of up to 4 weeks.

Researchers are now studying the properties of LFMS to determine the optimal frequency, spatial distribution, and timing of the electromagnetic field needed to produce an antidepressant effect.

Dr. Rohan is doing further investigation of the potential mechanisms of the device. He is also participating in a study of 72 patients that is looking at the effect and duration of multiple treatments, the results of which he estimated would be available by the end of next year.

Elsewhere, a multisite study funded by the National Institutes of Health is comparing the device with antidepressant interventions, said Dr. Rohan.

Encouraging Results

Commenting on the study for Medscape Medical News, Paul E. Holtzheimer, MD, associate professor of psychiatry and surgery, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, said the study was "great," the results "encouraging," the design "reasonably straightforward," and that he had "no major criticisms" of the research.

"There does seem to be an antidepressant effect; it's not a huge effect, but that's also true for transcranial magnetic stimulation and other approved treatments," said Dr. Holtzheimer. "It warrants further investigation, but in terms of trying to figure out how much of a splash this is going to make, it's too early to say."

The "exciting" aspect of LFMS, said Dr. Holtzheimer, is that it is mechanistically different from TMS in that it is less focal and could be affecting a broader area of the brain involved in mood regulation.

"Mechanistically, it's probably doing something different: it's a similar brain region and a similar idea in terms of altering electrical activity in the brain, but it's different in terms of how focal it is and how much it's altering that activity."

Dr. Holtzheimer warned against being overly enthusiastic about rapid results after using LFMS. He noted that when TMS and deep brain stimulation were first being studied, there were also reports of immediate effects. "Now, we have learned that it's not necessarily related to whether patients get better longer term."

He noted that some patients have an immediate response to drug therapies. "Even though we say that it takes 8 to 12 weeks to have a full effect, some patients get better very quickly."

The same is true for ECT, he added. "We say it takes 9 treatments, but some patients are well within the first 1 or 2 treatments."

McLean Hospital has been awarded patents for the low-field magnetic stimulation treatment and device. Dr. Rohan is listed as an inventor of these patents. He has received consulting fees from Taj Medical, which McLean Hospital approves and limits. Dr. Holtzheimer reports no relevant financial relationships.

Biol Psychiatry. 2014;76:186-193. Full text

Medscape Medical News © 2014  WebMD, LLC

Send comments and news tips to news@medscape.net.

http://www.medscape.com/viewarticle/829208

Thursday, July 24, 2014

Low field magnetic stimulation may offer immediate relief for patients with depression

 

Low field magnetic stimulation may offer immediate relief for patients with depression

By Tina Shah, Tech Times | July 23, 1:01 PM

 

Van Gogh depicts depression

Researchers at Harvard Medical School and Weill Cornell Medical College discovered that a single treatment of low field magnetic stimulation produced mood-elevating effects in depressed patients.
(Photo : Vincent Van Gogh (Wikipedia Commons))

Depression affects every part of a person's life-how he or she thinks, behaves, interacts with other people-and the diagnosis of clinical depression can sometimes require long-term treatment. Combinations of medication and counseling can often help a person through the disorder.

Other treatment options include electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS). ECT sends electrical currents through the brain and TMS sends magnetic pulses to the nerve cells that regulate mood and depression.

However, these treatments often take weeks to produce a full response. Researchers have been searching for a way to immediately produce mood-elevating effects. It seems that a lucky accident may have led researchers at Harvard Medical School and Weill Cornell Medical College to an answer.

The researchers found that low field magnetic stimulation (LFMS) produces the desired effects.

The researchers, led by Dr. Michael Rohan, were conducting an imaging study of healthy participants when they found some of the parameters that seem to induce the response of antidepressants. They went ahead and made an LFMS device that would send low strength, high frequency electromagnetic waves to the brain and tested it on depressed patients.  According to Rohan, LFMS uses only a fraction of the strength of the magnetic fields in TMS and ECT but produces a higher frequency.

63 depressed patients were given the LFMS treatment. In a randomized order, some patients were given a real treatment and some were given a fake in which the electromagnetic fields were deactivated.

"An immediate and substantial improvement in mood was observed in the patients who received real LFMS, compared to those who received the sham treatment. There were no reported side effects," said a statement.

The results show that this method, as well as the designed device for delivering it, might be effective in helping depressive patients find relief immediately, such as in emergency situations.

The study was published in the journal Biological Psychiatry. The editor of the journal, Dr. John Krystal, explains that the finding that weak electrical stimulation can alleviate depressive symptoms is quite surprising, but the case that Rohan and colleagues make is "compelling" and should be further studied.

Rohan's study only administered a single LFMS-treatment to patients, so additional studies are already underway to determine the effects of multiple treatments. Other aspects of the treatment that will soon be researched include how long lasting the effects of the treatment are, and what other parameters produce the best LFMS response.

http://www.techtimes.com/articles/11002/20140723/low-field-magnetic-stimulation-may-offer-immediate-relief-for-patients-with-depression.htm

Monday, July 21, 2014

Study: Trying harder makes it more difficult to learn language

Study: Trying harder makes it more difficult to learn language

Tuesday, 22 July 2014

When it comes to learning languages, adults and children have different strengths. Adults excel at absorbing the vocabulary needed to navigate a grocery store or order food in a restaurant, but children have an uncanny ability to pick up on subtle nuances of language that often elude adults. Within months of living in a foreign country, a young child may speak a second language like a native speaker.

Brain structure plays an important role in this "sensitive period" for learning language, which is believed to end around adolescence. The young brain is equipped with neural circuits that can analyze sounds and build a coherent set of rules for constructing words and sentences out of those sounds. Once these language structures are established, it's difficult to build another one for a new language.

In a new study, a team of neuroscientists and psychologists led by Amy Finn, a postdoc at MIT's McGovern Institute for Brain Research, has found evidence for another factor that contributes to adults' language difficulties: When learning certain elements of language, adults' more highly developed cognitive skills actually get in the way. The researchers discovered that the harder adults tried to learn an artificial language, the worse they were at deciphering the language's morphology -- the structure and deployment of linguistic units such as root words, suffixes, and prefixes.


"We found that effort helps you in most situations, for things like figuring out what the units of language that you need to know are, and basic ordering of elements. But when trying to learn morphology, at least in this artificial language we created, it's actually worse when you try," Finn says.

The findings support a theory of language acquisition that suggests that some parts of language are learned through procedural memory, while others are learned through declarative memory. Under this theory, declarative memory, which stores knowledge and facts, would be more useful for learning vocabulary and certain rules of grammar. Procedural memory, which guides tasks we perform without conscious awareness of how we learned them, would be more useful for learning subtle rules related to language morphology.


"It's likely to be the procedural memory system that's really important for learning these difficult morphological aspects of language. In fact, when you use the declarative memory system, it doesn't help you, it harms you," Finn says.


Still unresolved is the question of whether adults can overcome this language-learning obstacle. Finn says she does not have a good answer yet but she is now testing the effects of "turning off" the adult prefrontal cortex using a technique called transcranial magnetic stimulation. Other interventions she plans to study include distracting the prefrontal cortex by forcing it to perform other tasks while language is heard, and treating subjects with drugs that impair activity in that brain region.

http://macedoniaonline.eu/content/view/25746/56/