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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.”

Wednesday, December 17, 2014

An electrical cause of stridor: Pediatric vagal nerve stimulators.

Int J Pediatr Otorhinolaryngol. 2014 Nov 21. pii: S0165-5876(14)00592-8. doi: 10.1016/j.ijporl.2014.10.037. [Epub ahead of print]

An electrical cause of stridor: Pediatric vagal nerve stimulators.

Kelts G1, O'Connor PD2, Hussey RW3, Maturo S4.

Author information
  • 1San Antonio Uniformed Services Health Education Consortium, Otolaryngology, United States. Electronic address:
  • 2San Antonio Uniformed Services Health Education Consortium Center, Otolaryngology, United States.
  • 3San Antonio Uniformed Services Health Education Consortium, Pediatric Neurology, United States.
  • 4San Antonio Uniformed Services Health Education Consortium, Otolaryngology, United States.

Vagal nerve stimulators (VNS) are surgically implantable medical devices which are approved by the food and drug administration (FDA) for treatment of medically refractory epilepsy in children. Two children with seizures disorders presented to the pediatric otolaryngology clinic with complaints of stridor and sleep apnea following implantation of VNS devices. Both children were evaluated with flexible laryngoscopy, direct laryngoscopy and bronchoscopy. The children were noted to have contraction of their vocal folds and supraglottis and the settings of their VNS were adjusted until no further contractions were noted. Each child had resolution of their symptoms following adjustment.

Published by Elsevier Ireland Ltd.


Direct laryngoscopy; Sleep apnea; Stridor; Vagal nerve stimulator

[PubMed - as supplied by publisher]
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Vagus nerve stimulation could increase cardiac stability and reduce risk of SUDEP


Vagus nerve stimulation could increase cardiac stability and reduce risk of SUDEP

Journal name:
Nature Reviews Neurology
Year published:
Published online
16 December 2014

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An ECG study of individuals receiving vagus nerve stimulation (VNS) for drug-resistant focal epilepsy has demonstrated that VNS induces favourable changes in T-wave alternans, possibly reflecting improved balance between sympathetic and parasympathetic activity. T-wave alternans is an established noninvasive marker for risk of sudden cardiac death; the study finding, therefore,…

Monday, December 15, 2014




When insurance companies deny the mentally ill the treatment their doctors prescribe, seriously ill people are often discharged, and can be a danger to themselves or others


· 2014 Dec 14

· Correspondent Scott Pelley

Editor's Note: A statement from Dr. Samuel Nussbaum, chief medical officer, Anthem, Inc.

"Mental illness impacts millions of Americans, and is a serious medical issue that demands the attention of the entire country. Throughout the care of these individuals, our behavioral health professionals explored and provided the patients and families numerous care options that went beyond their covered benefits. In our experience, successful outcomes require a partnership between patients, families, medical professionals and health plans. As a company, we are dedicated to working together to help those whose lives are affected."

The following is a script from "Denied" which aired on Dec. 14, 2014. Scott Pelley is the correspondent. Michael Rey and Oriana Zill-de Granados, producers.

Two years ago tonight, we were reeling from the shock of the murders of 20 first graders and six educators at Sandy Hook Elementary School. Since then, we've learned that the killer suffered profound mental illness. His parents sought treatment but, at least once, their health insurance provider denied payment.

Because of recurring tragedies and an epidemic of suicides, we've been investigating the battles that parents fight for psychiatric care. We found that the vast majority of claims are routine but the insurance industry aggressively reviews the cost of chronic cases. Long-term care is often denied by insurance company doctors who never see the patient. As a result, some seriously ill patients are discharged from hospitals over the objections of psychiatrists who warn that someone may die.


Katherine West

In the pictures, there's no sign of the torment of Katherine West. But by the age of 14 she was wasting away, purging her food. Nancy West, Katherine's mother, was told by her doctors that the bulimia was rooted in major depression.

Nancy West: In fact, prior to the eating disorder, she was cutting so there were self-harming behaviors from, I would probably say, at least 12 on.

To stop purging she had to be watched around the clock. Her doctors prescribed treatment that could cost more than $50,000 at a hospital, for 12 weeks.

Scott Pelley: The insurance company stopped paying after six weeks?

Nancy West: Six weeks pretty much was it for them. They were done. And if you know about a mental illness, you don't cure a mental illness in six weeks.

The health insurance company was Anthem, second largest in the nation. An Anthem reviewer found Katherine should leave the hospital because she had put on enough weight. Her doctor warned that she was desperate to shed those pounds.


Nancy West

CBS News

Nancy West: They were telling the insurance company, "She needs to stay here. She needs more long-term treatment. She isn't ready for this."

The insurance company overruled the doctor. Katherine West came home as an outpatient.

Nancy West: I was texting her, no response. I got home at 12:30 that day and I found my daughter in bed. She'd been gone for hours. And I just remember running through the house screaming. I couldn't believe it. My beautiful girl was gone. She was gone.

Katherine was dead at the age of 15. As her doctors predicted, she'd been purging again, which led to heart failure.

Scott Pelley: Did it make sense to you that a doctor at the insurance company was making these decisions based on telephone conversations?

Nancy West: No. No, they didn't observe my daughter. You're talking about a psychiatrist, a pediatrician, a therapist who observed my daughter on a daily basis. But some nameless, faceless doctor is making this decision. And I was furious. Because basically to me he was playing God with my daughter's life.

The kind of review that resulted in the discharge of Katherine West works like this; after a patient is admitted, an insurance company representative starts calling the doctor every day, or every few days. If that representative decides that the patient is ready for a lower level of care, then the case is referred to an insurance company physician who reads the file, calls the doctor and renders a judgment. We have found in these chronic, expensive cases that judgment is most often a denial. How often the results are tragic, no one can say. But we have found examples.

"...some nameless, faceless doctor is making this decision. And I was furious. Because basically to me he was playing God with my daughter's life."

In 2012, Jacob Moreno's further hospitalization was denied even after a doctor warned, "the patient states that he wanted to kill other people, many people." The next day, Moreno was naked in the street, swinging at strangers and attacking a police officer. They used a Taser to take him down. The state ordered him back to the mental hospital. Richard Traiman's hospital stay was also cut short. As he was being discharged, he said he would throw himself off a bridge. He didn't. He hung himself the next day.

Harold Koplewicz: They're called managed care, but it's really managed cost.

Dr. Harold Koplewicz knows insurance review calls well, he's a leading psychiatrist and founder of a research organization, the Child Mind Institute.

Harold Koplewicz: When I was running an inpatient unit, I would have to literally speak to a clerk on the phone to say, "I need approval for this patient to stay here another five days." And they would say to me, "Well, is the patient acutely suicidal or acutely homicidal?" "Well, not right now because he's in the hospital. We took the knife away. We took the gun away. We took the poison away." And they would say, "Well, then why does he have to be in the hospital?" You think to yourself, "Am I in--is this Oz?"

Scott Pelley: The insurance company wants to send 'em home?

Harold Koplewicz: Well, it's a lot cheaper in the short run. And if you're managing costs on a quarterly basis, you can understand why from a business point of view for that quarter it makes sense. For the sake of the child, for the sake of our society, for the sake of the child's future it doesn't make any sense

Of all the cases we looked at, one of the most revealing was Ashley's. She suffers from bipolar disorder.

Ashley: In 2012, I had had a suicide attempt. I couldn't find a way out.

Scott Pelley: Was this a cry for help or did you want to die?

Ashley: This one was real. I was alone. I tried my best.

Ashley's mother, Maria, asked us not to mention the family name.

Maria: One of the doctors told me on the phone, "I'm really sorry, but you will probably bury your daughter."

In 2012, Ashley was in the hospital for the fourth time that year. They thought they had taken away everything that could hurt her. But she smashed her cell phone and cut her wrists with the glass.

Scott Pelley: What did that tell you, in terms of the treatment that she needed?

Maria: It told me that she needed long-term treatment to survive.

Maria says that Anthem recommended treatment at Timberline Knolls, a residential facility. A doctor said Ashley needed 90 days. But after sending her to Illinois from California, Anthem denied payment after six days saying that Ashley could be, "safely treated with outpatient services."

Scott Pelley: Did the people at Timberline Knolls believe that?

Maria: No, they didn't--

Scott Pelley: That she was well?

Maria: No. They absolutely didn't believe it. They gave us the option of paying $22,000. For-- to complete the 30 days. And at that, we-- there wasn't a chance that we could do that.

Now, look at how Ashley's care was denied. This log shows Dr. Tim Jack, a psychiatrist working on behalf of Anthem, called Ashley's doctor three times in 32 minutes. One call was disconnected. He left two messages. Dr. Jack waited 22 minutes for a call back, and then denied coverage. From the first call to denial, 54 minutes, speaking to no one.

Why so fast? Well, it may be, in part, because many insurance doctors are paid by the case. Dr. Jack, is a contractor who gets $45 per patient. In court records, Dr. Jack says he does 550 reviews a month. So, working from home, that comes to $25,000 a month. We spoke to 26 psychiatrists from across the country, and every one brought up Dr. Jack's name. Some called him "Dr. Denial." This is a recording of Dr. Jack telling a physician that a patient's level of care should be lowered.

Dr. Tim Jack: Because given what his current progress is and his current symptoms are, he can be managed at a lower level of care as effectively as in an intensive outpatient program.

Doctor: You know doctor, I just want to say that I have spoken to you on so many different occasions, and with so many different clients, and I've never really had a positive outcome as far as authorization from you, so...I just needed to bring that to your attention.

Dr. Tim Jack: This is not a personal matter.

Doctor: I understand sir, but the client appears to meet the criteria, so...

We found Dr. Jack's denial rate averaged 92 percent in one six month period in 2011. But that was typical among 11 reviewers contracted by Anthem. Some of them had denial rates of 95 and 100 percent.

Scott Pelley: What's the impact on a family after a phone call like that?

Kathryn Trepinski: Devastating.

Kathryn Trepinski is a lawyer who represents patients. She does not represent Ashley's family, but she has filed suit against Anthem and other insurers.

Kathryn Trepinski: There's untold suffering and the family is usually left in the very difficult-- position of either paying for the care out of pocket, which is tens of thousands of dollars. Or they say no to their loved one, to their child.

Anthem says that reviews are checked by a supervising doctor but when we obtained Ashley's denial letter we found her review by Tim Jack, MD, was supervised by Timothy Jack, MD.

Scott Pelley: So he signs the documents twice?

Kathryn Trepinski: Yes, except that he doesn't actually sign them himself. It's a robo-signature.

Dr. Jack has acknowledged an Anthem computer put his name to letters he doesn't see and on cases he didn't review.

Kathryn Trepinski: It suggests a layer of review that's not there. Because the signing doctor is described in the letter as having made that coverage determination and he didn't.

We tried to reach Dr. Jack in calls and a letter. We stopped by his home. But he declined to speak. Katherine West's and Ashley's parents gave us permission to ask Anthem about their cases. Anthem declined an interview but its chief medical officer wrote that they, "explored and provided the...families numerous care options that went beyond their covered benefits." He goes on to say "successful outcomes require a partnership between [sic] patients, families, medical professionals and health plans."

For the insurance industry's view, we found Anthem's former California medical director, Dr. Paul Keith. He retired in March after years supervising Anthem reviews, including those of Dr. Jack. He told us that, too often insurance companies are abused by care providers.


Dr. Paul Keith

CBS News

Dr. Paul Keith: Doctors will spin the clinical information. They will make things appear more serious than, perhaps, they are, because they feel strongly the patient needs this level of care for a little longer. So you do have a somewhat adversarial relationship between the reviewer and the attending physician.

Scott Pelley: You're saying the-- the doctor will overstate the case to get the insurance company to approve the client?

Dr. Paul Keith: Unquestionably that happens. Not all the time and I've been doing this for, you know, over 30 years.

Scott Pelley: You describe these conversations as "adversarial," is that best for the patient?

Dr. Paul Keith: Well, it's like our legal system if you, each side, does a good job in presenting their case and asking the right questions, you ultimately arrive at the truth.

Scott Pelley: But these can be life and death decisions and you don't know till it's too late.

"Doctors will spin the clinical information. They will make things appear more serious than, perhaps, they are, because they feel strongly the patient needs this level of care for a little longer..."

Dr. Paul Keith: I cannot, offhand, think of a situation where a decision was made to discharge a patient from a hospital and some terrible consequence occurred soon thereafter. I'm sure it happens, but--

Scott Pelley: We found quite a few.

Dr. Paul Keith: I'd have to look at them to see. There's one that occurs to me that I was involved with where the child left the hospital with his parents, escaped from his parents, drove cross country to another state, and days later, committed suicide. Keeping that individual in the hospital longer is not likely to have made any difference.

Scott Pelley: I would have to imagine that the parents would say, "If you'd kept him in the hospital, he wouldn't have been in another state killing himself."

Dr. Paul Keith: Parents become fearful that if they leave too soon, the same thing's gonna happen that may have happened in previous occasions, but you can't keep an individual in the hospital forever.

Scott Pelley: So to the parent who says the insurance company is just trying to get my child out of the hospital, you say what?

Dr. Paul Keith: It's half true; the insurance company may very well want that child to go to a lesser level of care, but money is not the basis for the decision.

Scott Pelley: A lot of people watching this interview are gonna have trouble with the idea that insurance companies are not trying to save money.

Dr. Paul Keith: Of course, your insurance companies are trying to save money. There's a lot of treatment that is not medically necessary that is provided, and that is a waste of healthcare dollars and the resources are scarce.

Ashley's family hired a lawyer and appealed to the California Insurance Board which overturned Anthem's denials. Now, she is in treatment for bipolar disorder, treatment that may last a lifetime. Katherine West was buried a year ago this month, her mother has filed suit against Anthem.

After the mass murder at Newtown, the state of Connecticut's Sandy Hook Commission studied mental health. A draft of its upcoming report calls the insurance review process a "formidable barrier... to care" and recommends a state agency review all denials.

© 2014 CBS Interactive Inc. All Rights Reserved.

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herb1008 5ptsFeatured
57 minutes ago

Dear Mr. Pelley,

Nice media presentation on your part except for the fact it doesn’t even scratch the surface of the inequities, discrimination and subterfuge perpetrated against those with mental health issues.

I have been battling with HHS and CMS as well as Madam Secretary Sylvia Mathews Burwell as well as Stephen J. Hemsley - CEO, United Healthcare to rightfully cover patients who have benefitted from VNS Therapy for Depression.

How’s about this fact?I finally cajoled CMS to cover the Medicare/Medicaid study subjects and patients for their medical insurance.Here’s the sad joke.United Healthcare as a result of CMS’s prompting has covered Medicare patients but refused to cover private pay patients.Same company, same therapy but Stephen J. Hemsley - CEO, United Healthcare, who’ve I written to many times, refuses to cover at least one of his private pay patients.

Volunteer study subjects with implanted medical devices left to their own challenges to obtain medical coverage and care.Screwed up and discriminatory mental health care system; you bet.

My efforts to overcome this abortion can be found in my writings on blog site:

Mr. Pelley if you’d like another interesting and convoluted story to add to your portfolio I’m readily available to share details.



Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

Wednesday, December 10, 2014

Laughing gas found helpful as treatment for severe depression

December 10, 2014 by Donna Crepeau

Laughing gas found helpful as treatment for severe depression

Laughing gas found helpful as treatment for severe depressionPatients that suffer from severe depression and would not respond to normal therapies have been found responding to nitrous oxide or laughing gas treatment.

A research conducted at the Washington University School of Medicine in St. Louis has shown patients with treatment-resistant clinical depression improved significantly within a day or two of being administered with nitrous oxide.

Nitrous oxide, also known as laughing gas, is an inhalation anesthetic used in dentistry and surgery – but has been found helpful for treating depression. Twenty patients were administered with this gas, and two-thirds reported significant improvements 24-hours after receiving laughing gas, while a one-third that received placebo reported they were not in any way better.

In order to be certain of the results achieved with nitrous oxide, the researchers replicated their trials and the same findings were obtained. Patients with severe depression were given two kinds of treatments – but neither the patients nor the researchers understood the order for administering the treatments; a group of patients were given a mixture of half oxygen and half nitrous oxide, and the other group was given a placebo mixture of oxygen and nitrogen – the two atmospheric gases we breathe in the air.

The first group that got half oxygen-half nitrous oxide reported a day after the gas was administered that feelings of sadness, guilt, anxiety, suicidal thoughts, and insomnia was greatly diminished: seven patients reported significant improvements, seven confirmed they had mild improvements, three confirmed that their conditions were almost disappeared, but no patients reported any side-effects.

The second group that had placebo treatment reported very little improvements: one’s condition worsened after the treatment, two others experienced considerable improvement, and five reported they only felt better.

But according to Dr. Charles R. Conway, “most patients that received nitrous oxide reported rapid and significant improvements in their health conditions.”

Published in the journal Biological Psychiatry, the researchers are interested in knowing if laughing gas could be administered to other groups of patients with depression – and they intend to test out various concentrations of the gas to determine how it influences the treatment of depression symptoms.

Monday, December 8, 2014

Cyberonics Reports Consistently Positive Results From The E-36 And E-37 Studies For VNS Therapy Delivered By AspireSR®

Cyberonics Reports Consistently Positive Results From The E-36 And E-37 Studies For VNS Therapy Delivered By AspireSR® Generator New Results Presented at the 68th American Epilepsy Society (AES) Annual Meeting

HOUSTON, Dec. 8, 2014 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ: CYBX), maker of the VNS Therapy® System implanted in more than 80,000 patients, announced new results from two multi-site clinical studies of the AspireSR generator, E-36 (NCT01325623) and E-37 (NCT01846741), at the AES Annual Meeting in Seattle, Washington.  The AspireSR generator is currently investigational in the U.S. and not approved for commercial use.  The AspireSR generator attained the CE Mark and is now available in an increasing number of European countries.

Investigators presented results from the European E-36 study and the U.S. E-37 study, which assessed the acute impact of the AspireSR generator on seizure duration and termination, as well as the long-term evaluation of safety, clinical benefit of the automatic stimulation feature, and quality of life.  Assessments of seizure severity and quality of life were made using validated scales scored by patients[1],[2] and physicians[3].

The acute impact of the AspireSR generator on seizure duration and termination was evaluated during the Epilepsy Monitoring Unit stay period experienced by all patients in both studies.  Seizure activity was recorded using concurrent video-EEG and ECG monitoring.  Patients in both studies experienced termination of seizures as well as reduced seizure duration during automatic stimulation compared to historical controls.

During three- and six-month follow-up, patients in both studies experienced clinically significant reduction in several key components of seizure activity compared to baseline, including overall seizure severity, movements that could result in harm, and various aspects of post-ictal recovery. 

"These clinical results show that the AspireSR VNS Therapy System is safe and effective for detecting and reducing the burden of seizures in patients with drug-resistant epilepsy," said Paul A.J.M. Boon, MD, PhD, Professor and Chairman of the Department of Neurology and Director, Institute for Neuroscience, Ghent University Hospital.  "The AspireSR generator shows a similar clinical benefit to the manual magnet-activated stimulation provided by the existing VNS Therapy systems, but with added convenience to both the patient and caregiver."

"More than 60% of patients receiving VNS Therapy report benefits from manual magnet activation[4], yet not all patients can use this feature during a seizure as the result of the disabling effects of the seizure, cognitive impairment, seizures that occur during sleep, or seizures that occur without an aura," added Robert Fisher, MD, PhD, Director of the Stanford Epilepsy Center, Palo Alto, CA.  "The AspireSR generator delivers programmed VNS Therapy with the addition of automatic stimulation based upon the increased heart rate that accompanies many seizures.  This feature can provide the acute stimulation benefit to more patients with drug-resistant epilepsy."

About Drug-Resistant Epilepsy and VNS Therapy

Epilepsy is the fourth most common neurological disorder and one in 26 people will develop epilepsy at some point in their lifetime.  Antiepileptic drugs are typically the first option for treating epilepsy.  While many people with epilepsy have success with these drugs, as many as one-third of people with epilepsy experience seizures that persist in spite of treatment with medications alone.[5],[6]

Cyberonics' VNS Therapy System is an FDA-approved medical device specifically developed for the adjunctive treatment of drug-resistant (medically refractory) epilepsy.  Treatment with VNS Therapy does not involve brain surgery, but rather the implanted medical device delivers mild, pulsed electrical signals to the vagus nerve, which projects to areas of the brain that are known to be implicated in seizures.  Studies show that a majority of people with drug-resistant epilepsy experience a 50-90% reduction in seizures with VNS Therapy[7] and report improvements in quality of-life[8].

More information about VNS Therapy is available at or by contacting  

Safe harbor statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended.  These statements can be identified by the use of forward-looking terminology, including "may," "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or other similar words.  Statements contained in this press release are based on information presently available to us and assumptions that we believe to be reasonable.  We are not assuming any duty to update this information if those facts change or if we no longer believe the assumptions to be reasonable.  Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning obtaining FDA approval for and expanding the commercial market for the AspireSR generator.  Our actual results may differ materially.  Important factors that may cause actual results to differ include, but are not limited to:  continued market acceptance of the VNS Therapy System and sales of our products; the development and satisfactory completion of clinical studies; the achievement of regulatory approval for new products, including use of the VNS Therapy System for the treatment of other indications; satisfactory completion of the post-market registry required by the U.S. Food and Drug Administration as a condition of approval for the treatment-resistant depression indication; adverse changes in coverage or reimbursement amounts by the Centers for Medicare & Medicaid Services, state Medicaid agencies and private insurers; the presence or absence of intellectual property protection and potential patent infringement claims; maintaining compliance with government regulations; product liability claims and potential litigation; reliance on single suppliers and manufacturers for certain components; the accuracy of management's estimates of future expenses and sales; the potential identification of material weaknesses in our internal controls over financial reporting; and other risks detailed from time to time in our filings with the Securities and Exchange Commission ("SEC").  For a detailed discussion of these and other cautionary statements, please refer to our most recent filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended April 25, 2014, and our Quarterly Report on Form 10-Q for the fiscal quarters ended July 25, 2014 and October 24, 2014.

Contact information

Greg Browne, CFO
Cyberonics, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
Main:  (281) 228-7262
Fax:  (281) 218-9332

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SOURCE Cyberonics, Inc.