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Thursday, May 31, 2012

Effects of eTNS™ on Post-Traumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD) examined as an adjunct to pharmacotherapy

Interim Results Reported for Phase I Open-Label Clinical Trial for the Treatment of PTSD and MDD Using External Trigeminal Nerve Stimulation (eTNS™) - The USB Port to the Brain™

Effects of eTNS™ on Post-Traumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD) examined as an adjunct to pharmacotherapy

Average decreases in PTSD measures of 36% recorded

LOS ANGELES, May 30, 2012 /PRNewswire/ -- Today, at the 52nd annual New Clinical Drug Evaluation Unit (NCDEU) Conference in Arizona, Ian Cook, M.D., Professor of Psychiatry at the University of California, Los Angeles (UCLA) and a Senior Medical Advisor to NeuroSigma, Inc., presented the results from the first 6-subject cohort of a 10-subject Phase I open-label clinical trial studying the effects of external trigeminal nerve stimulation (eTNS™) on Post-Traumatic Stress Disorder (PTSD) and depressive symptoms in Major Depressive Disorder (MDD) as an adjunct to pharmacotherapy. The trial is being conducted at UCLA and is funded by NeuroSigma. Mean decreases in PTSD measures of 36% and depression measures of over 50% were reported.

The study was conducted over an 8-week period and followed similarly designed eTNS trials conducted at UCLA, in which promising results were generated in treating both major depression and epilepsy. Subjects had a mean age of 54 with a median of 28 years since traumatic exposure and suffered from both PTSD and MDD. Current episodes were required to be of at least four months in duration, with non-response to at least one antidepressant. In this outpatient trial, subjects placed stimulating eTNS electrodes on their foreheads for approximately eight hours each night while asleep, and the severity of PTSD and depression symptoms was measured every two weeks using standard recognized rating scales.

"These findings are very encouraging," said Dr. Cook. "The combination of depression and an anxiety disorder, like PTSD, is usually difficult to treat effectively. The participants in the study told us that eTNS was easy to use at home and led, in some instances, to the best mental health they had experienced in years. We expect these results, along with results from the remaining subjects in this Phase I trial, to form the basis for an upcoming Phase II clinical trial that will examine efficacy, tolerability, and safety in a larger sample with a double-blind, controlled trial design."

Lodwrick Cook, Chairman of NeuroSigma, added, "PTSD is a serious global disorder drastically in need of promising new therapies. As Americans we have an obligation to do our utmost to help the thousands of fellow citizens who are stricken by PTSD as a result of both military and non-military related traumatic events. We are very pleased by the preliminary results and applaud the efforts of the clinical team at UCLA."

PTSD, commonly associated with the effects of warfare, arises after exposure to a traumatic event; such as train bombings and terrorist attacks as experienced on September 11th, or natural disasters such as Hurricane Katrina and the massive Fukushima earthquake and tsunami in Japan, or personal tragedies affecting those involved in traffic accidents, domestic violence or sexual assault. It is marked by symptoms in three groups: those of re-experiencing (nightmares, flashbacks), those of avoidance and numbing (isolation from others, avoiding reminders), and increased arousal (being on edge, hyper-alert, subject to explosive responses when startled). PTSD is often accompanied by depression, and many of the medications used to treat PTSD were first developed as antidepressants. However, recent studies suggest that having an anxiety disorder, such as PTSD, significantly reduces the likelihood that antidepressants will work, making the treatment of PTSD very challenging. The August 2011 issue of the Journal of the American Medical Association reported that a widely prescribed antipsychotic medication may be no more effective than placebo in treating PTSD.

NeuroSigma, Inc., a Los Angeles-based medical technology company established to in-license and develop early stage technologies with the potential to transform medical practice, is the exclusive worldwide licensee of UCLA's TNS intellectual property, including eTNS for PTSD and depression.

Dr. Ian Cook added, "I'm confident that the transfer of the technology from academia to the next phase of trials will go smoothly and that, with replication, this treatment has the opportunity to be made available to help many of those who suffer with PTSD and major depression. Given the external, non-invasive nature of this therapy, it might be useful in the battlefield or in an emergency room immediately after a traumatic event, with the theoretical potential to impact the development of full-blown PTSD."

Background - TNSNeuroSigma is commercializing two embodiments of trigeminal nerve stimulation (TNS): eTNS™ (external electrodes and an external pulse generator) and sTNS™ (subcutaneous electrodes and implantable pulse generator). The eTNS system utilizes a self-adhesive conductive pad applied to the forehead to stimulate branches of the trigeminal nerve, which are located very close to the surface of the skin in the forehead. The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain. In clinical studies, eTNS is well tolerated and the low-energy stimulus is confined to the soft tissues of the face without direct penetration into the brain – hence the term "USB Port to the Brain™."

The trigeminal nerve projects to specific areas of the brain, such as the locus coeruleus, nucleus tractus solitarius, thalamus and the cerebral cortex, which are involved in epilepsy, depression, PTSD and other disorders. PET imaging studies in humans confirms that eTNS activates or inhibits key regions implicated in these disorders and the changes were observed within minutes of therapy. Once approved by regulatory agencies, patients who respond well to eTNS can opt to switch to the implantable sTNS system. NeuroSigma has completed development of its eTNS system and is seeking CE Mark approval in Europe for the treatment of epilepsy and depression. NeuroSigma is concurrently developing its implantable sTNS system.

CAUTION: Both eTNS™ and sTNS™ systems are investigational devices and at this time are limited by Federal (United States) law to investigational use.

About NeuroSigma, Inc.NeuroSigma is a Los Angeles-based medical technology company established to develop early stage technologies with the potential to transform medical practice. Currently, NeuroSigma is focused on a number of neuromodulation therapies and through its majority-owned subsidiary, NSVascular, Inc., on Thin-Film Nitinol covered stents for endovascular applications. NeuroSigma employs two neuromodulation therapy platforms: Trigeminal Nerve Stimulation (TNS) and Deep Brain Stimulation (DBS). NeuroSigma has amassed significant intellectual property licensed on an exclusive basis from the University of California, Los Angeles (UCLA), including potential therapies for epilepsy, depression, post-traumatic stress disorder (PTSD) and attention-deficit hyperactivity disorder (ADHD) via TNS, and for PTSD and obesity via DBS. For more information about NeuroSigma, please visit

Forward-Looking Safe Harbor Statement: This press release contains forward-looking statements, including but not limited to, research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding our eTNS™ and sTNS™ systems. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new medical device products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations.

Friday, May 18, 2012

KTLA Health Smart: TMS Procedure Helps Fight Depression

KTLA Health Smart: TMS Procedure Helps Fight Depression

The procedure may provide relief from dozens of medications for depression that are on the market but don't always work.
VIDEO: Watch Jessica Holmes' report


4:31 AM PDT, May 18, 2012

TMS Procedure

LOS ANGELES (KTLA) -- A non-invasive, drug-free procedure is helping people with depression have breakthroughs.

Transcranial Magnetic Stimulation, known as TMS, is a method in which a magnet stimulates the frontal lobe, improving connections and activity of the brain.

The procedure has been approved by the FDA and doctors say it's ideal for pregnant women and breast-feeding mothers battling postpartum.

There may be some side effects such as headaches and nausea.

The procedure may provide relief from dozens of medications for depression that are on the market but don't always work.

Around 17 million Americans will experience depression at some point in their lives, according to the World Health Organization.

Depression rates have jumped nearly 50 percent over the past decade in Los Angeles County.

Celebrities such as Catherine Zeta-Jones, John Hamm and even the late Mike Wallace have come forward and admitted battling depression.

"Eight percent of our patients have responded favorably to TMS," said Dr. Kira Stein at the West Coast TMS Institute.

TMS Improves Quality of Life in Drug-Resistant Depression

TMS Improves Quality of Life in Drug-Resistant Depression

Caroline Cassels
May 17, 2012 (Philadelphia, Pennsylvania) — Transcranial magnetic stimulation (TMS) is not only effective in the treatment of antidepressant-resistant major depression but also appears to significantly improve patients' quality of life (QoL) and functional status, new research suggests.

Further, the observational findings from the multicenter, community-based study presented here at the American Psychiatric Association's (APA's) 2012 Annual Meeting suggest that TMS treatment has a statistically significant impact on QoL during acute treatment.

The NeuroStar (Neuronetics, Malvern, Pennsylvania) system used in the study was cleared for use by the US Food and Drug Administration (FDA) in 2008 for antidepressant-resistant major depressive disorder (MDD), as reported by Medscape Medical News at that time.

Although research indicates that TMS is effective in reducing depressive symptoms of depression, its impact on QoL was previously unclear.

"The study shows that when patients have symptom improvement with TMS, that improvement spreads out to all aspects of their lives — they can resume life again," study coauthor Ian Cook, MD, who headed up the site at the University of California, Los Angeles, told Medscape Medical News.

Dr. Ian Cook
"Prior studies have focused on symptom response, which is of course what academic medicine relies upon and what the FDA relies upon, but patients often grade on a different scale, and they want their lives back, and that's what these ratings really were assessing," he added.

Noninvasive Option
The NeuroStar TMS system is a noninvasive therapy that delivers magnetic resonance imaging (MRI)–strength pulsed magnetic fields to induce an electric current in a localized region of the cerebral cortex.

Investigators note that this modality may offer treatment-resistant patients a noninvasive therapeutic option with no systemic side effects for a condition notoriously difficult to treat.

First-line treatment for depression includes antidepressant medication and/or psychotherapy. However, research indicates that most depressed patients either do not improve or achieve only a partial response.

The study included 307 patients (205 women) with a primary diagnosis of unipolar, nonpsychotic MDD. The average age of the patients was 48.6 years. The most common primary diagnosis was recurrent, nonpsychotic unipolar MDD (92.8%). All participants had failed previous antidepressant treatment.

"These are people who are approaching 50 years old. They have had the illness before, they have been treated before, they are being treated now, typically on multidrug treatment regimens, and they are not doing very well," lead author Mark A. Demitrack, MD, chief medical officer of Neuronetics Inc, told Medscape Medical News.

Early Response
Patients received therapy 5 times per week for 4 to 6 weeks. QoL and functional data were assessed across the course of this acute treatment period at 43 clinical practice sites in the United States.

To assess QoL and functional outcomes, the researchers used the Medical Outcomes Study Short Form, 36-Item (SF-36) and the Euro-Quality of Life Questionnaire-5 Dimensions (EQ-5D).

At study completion, self-reported QoL was statistically significantly improved on all measures of the EQ-5D (P < .0001) and the SF-36 (P < .0001) compared with baseline.

Ordinarily, patients who respond to antidepressant medication experience improvement in depressive symptoms within the first 6 to 8 weeks of treatment, and these are followed by improved functional outcomes further down the road, said Dr. Demitrack.

No Systemic Exposure
In practical terms, patients are able to "participate in their usual activities, which covers everything from going to work to being a good parent and all the other things that make up human life and give it meaning, and again this was all detected within the first typically 6 weeks of treatment, which is a lot sooner and much better for patients than having to wait months and months to see these measures of improvement," said Dr. Cook.

Dr. Demitrack added that unlike antidepressants and other psychotropic medications such as atypical antipsychotics used to treat major depression, there is no systemic exposure with TMS, and therefore its side effect profile is more favorable. About one third of patients experience transient cutaneous discomfort on the scalp during treatment.

"This is a prickly or percussive-like sensation which is generally tolerable and usually resolves after the first week of treatment," he said.

According to Dr. Demitrack, next research steps include testing the durability of TMS treatment in this patient population with a pilot study comparing 2 different TMS maintenance regimens.

In one study arm, patients will undergo acute treatment followed by no maintenance therapy unless they become symptomatic. The second arm will examine the effect of acute treatment, which will be tapered until it reaches a once-monthly maintenance phase.

TMS is currently included as a treatment option in the APA depression treatment guidelines and has been assigned Current Procedural Terminology (CPT) codes by the American Medical Association.

Reassuring, Not Surprising
Commenting on the study for Medscape Medical News, Paul E. Holtzheimer, MD, director, Mood Disorders Service, Dartmouth-Hitchcock Medical Center in New Hampshire, said the QoL findings are reassuring but not surprising.

"It is good to know that quality of life does actually change and people become more functional. But since depression, even minor depression, contributes to poorer quality of life, you would fully expect that as depression symptoms improve, so would quality of life. In that sense, the results aren't surprising," he said.

Dr. Holtzheimer, who has been involved in TMS research for more than a decade, noted that there is no doubt the modality has "statistically significant antidepressant effects."

However, there are still a number of outstanding questions about the treatment that need to be answered.

Key among them, said Dr. Holtzheimer, is whether the current treatment parameters are optimized or whether more aggressive treatment can be administered in patients at the most treatment-resistant end of the spectrum.

Further, mechanism of action studies using electroencephalography or brain imaging may help identify those patients who are most likely to benefit from TMS.

"So, for example, can we identify brain activity patterns that may help us tailor the treatment for individual patients so that if they have a specific abnormality in prefrontal functioning, can we dial in the right treatment parameter?"

Finally, although the prefrontal cortex has been identified as the primary treatment target for depression, there is still a question of whether there are other areas of the brain for which treatment may be equally or possibly more efficacious in some patients, said Dr. Holtzheimer.

Dr. Demitrack is the chief medical officer of Neuronetics, Inc. Dr. Cook reports that he is a consultant for BMS and Pfizer Inc and has received grant/research support from Neuronetics Inc, Sepracor Inc, NeoSync, and Seaside Therapeutics. He also reports that he a member of Neuronetics Inc speaker's bureau. Dr. Holtzheimer reports that he is a paid consultant for St. Jude Medical Neuromodulation and Cervel Neurotech and has received an honorarium from Johnson & Johnson.

The American Psychiatric Association's 2012 Annual Meeting. Abstract #NR9-31. Presented May 8, 2012.

Wednesday, May 9, 2012

Successful removal and reimplant of vagal nerve stimulator device after 10 years.

Ann Indian Acad Neurol. 2012 Apr;15(2):128-9.

Successful removal and reimplant of vagal nerve stimulator device after 10 years.


Department of Neurosurgery, Bellaria Hospital, Bologna, Italy.


The number of implanted vagal nerve stimulators is growing and the need for removal or revision of the devices will become even more frequent. A significant concern about Vagus Nerve Stimulation (VNS) therapy is the presence of the spiral stimulating electrodes, wrapped around the nerve, once treatment is considered ineffective or is no longer desired. Our purpose is to demonstrate the feasibility of complete removal and replacement of the vagal nerve stimulator electrodes using microsurgical technique even after a long period, without damaging the nerve. We attempted removal and replacement of spiral stimulating electrodes from a patient who received a 10-year long VNS therapy for drug-resistant epilepsy. Our results indicate that the spiral electrodes may be safely removed from the vagus nerve, even after several years. The reversibility of lead implantation may enhance the attractiveness of VNS therapy. Furthermore, with a correct microsurgical technique, it is possible to respect the normal anatomy and functionality of vagal nerve and to reimplant a new VNS system with all its components, maintaining the same therapeutic efficacy after many years.
PMID: 22566727 [PubMed - in process]

Related citations in PubMed

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Patient finds TMS therapy helpful in battle with depression

Patient finds TMS therapy helpful in battle with depression

Posted: 12:00am on May 8, 2012; Modified: 9:23am on May 8, 2012

Joe Paull/jpaull@ledger-enquirer.comJanna O'Loughlin, the transcranial magnetic stimulation (TMS) coordinator at the Bradley Center, and patient Floyd Bidleman offer a demonstration of the TMS therapy that was used to treat Bidleman's depression.
    If you're interested in learning more about transcranial magnetic stimulation therapy or would like to set up a consultation, contact Janno O'Loughlin, TMS coordinator, at 706-320-3792.

In 2010 the U.S. Food and Drug Administration approved a new type of therapy for people suffering from major depressive disorder -- transcranial magnetic stimulation, or TMS.

TMS therapy uses a device that focuses magnetic pulses to a specific area of the brain in order to stimulate neurons which are believed to be underactive in patients with depression, said Rizwan Kahn, DO, a board certified psychiatrist at St. Francis Hospital. TMS therapy is available at The Bradley Center.

Kahn said that as opposed to antidepressant medication or electroconvulsive therapy (ECT, or "shock therapy"), which are systemic treatments that can improve depressive symptoms, but can also cause side effects to other parts of the body, "with TMS … it's a very localized area that we're targeting in the brain."

Kahn said when a treatment is administered, doctors look for either response or remission from the patient. Response means that the patient gets 50 percent better from his or her baseline; remission means the patient is basically free from depressive symptoms. So far, six patients who have undergone TMS therapy at The Bradley Center have achieved remission, said Kahn.

TMS has only been FDA approved to treat major depressive disorder (commonly known as clinical or severe depression), but studies and research are currently being conducted to see what other uses TMS might have for disorders such as chronic pain and anxiety.

"There's burgeoning research with this modality because it's very well tolerated," said Kahn. "If you have a treatment that's well tolerated, that can be a big plus. I think there is a very bright future with this modality as far as broadening its use in other illnesses goes because the data has been very impressive with the results as well."

Patients interested in TMS therapy first have a consultation to see if they're appropriate candidates. A patient can be referred to the treatment from a therapist or contact the TMS coordinator directly.

If approved, the patient undergoes treatment five days a week for a total of 20 to 30 treatments. Kahn said the first appointment takes about an hour, but after that appointments last about 30 minutes.

During the treatment, TMS coordinator Janna O'Loughlin conducts a counseling session with the patient. O'Loughlin, a licensed professional counselor, is also responsible for TMS consultations and administering the treatment.

Floyd Bidleman, a 43-year-old Columbus resident, recently sat down with the Ledger-Enquirer to talk about his treatment. This interview has been edited for length and clarity.

Could you start off talking about some of the other treatments you tried after being diagnosed with major depression?

I was diagnosed with major depression two years ago. I went through in-patient treatment at the Bradley Center and then I went through the out-patient treatment and that was in June of last year.

Was that largely therapy sessions?

It was therapy sessions, coping sessions and how to deal with the depression and stuff like that. During the process I was going through medication -- I went through all the different antidepressant medications and none of them seemed to work at the time. And this last year, about June this last year, I had another bout and that's when they suggested I go through the TMS.

What were your initial thoughts when they first told you about this kind of therapy and what it was going to do?

My initial thought was 'What kind of treatment is it?' and what will it be like and will it help me? And would it stop my depression.

Were you scared at all?

To be honest, the first treatment was kind of interesting, to say the least. But it was uncomfortable. But after the first session it was okay. I knew what was going to happen and what it was going to be like.

How many sessions have you gone through?

I went through 26 sessions, the whole 26 sessions. I've been through it for … end of February was my treatment, so it's been a few months.

When did you start to notice a difference?

I started to notice a difference about the fourth week. My mood began to pick up a little bit, I didn't have such a down outlook on life.

What are some of the major changes you've noticed in yourself since going through TMS therapy?

I noticed that, like I said, I don't have a (negative) outlook towards life. I've been having a lot more to do with my family. Work doesn't seem to get to me as much and everyday life has become a little better.

So are you able to handle stress better?

Yes, I am. Yes, I am.

What has the response been like from your family?

They seem like, they think I'm a different person. I'm a better person. I'm not as withdrawn as I used to be.

What were some of the things you were going through during the depressive stages that was having a major impact on your life?

My outlook on life was -- I didn't have an outlook. I just, honestly, I just didn't want to be here. Depression can do that do you. I just didn't want to be, per se, alive at the time. I didn't want to do anything. I just pretty much slept and was kind of like a zombie. And now it's a complete 180. I have a lot more to do. My outlook on life is a lot better.

What would you say to somebody who was considering going through TMS treatment?

I would say to go through the treatment because if medication hasn't worked in the past, it's a treatment that will work. And if it gets you off medication, it's well worth the process.

And have you had any follow up treatments? Or is it mostly counseling?

I have had no follow-ups. I have a maintenance drug, just one little maintenance drug that I take and I do talk to a counselor every week.

Read more here:

Fighting the Odds: How One Birmingham Mom is Working to Live With Epilepsy

Fighting the Odds: How One Birmingham Mom is Working to Live With Epilepsy

After a risky surgery in 2009, life has become somewhat normal for this mother, wife and PR executive. "I have my moments ... but I try not to feel sorry for myself."
That’s because every day, Mengason wakes up wondering: “Will I have a seizure today?”
Mengason is one of 3 million Americans who suffer from epilepsy, the incurable neurological disorder that dogs its patients with unpredictable seizures.

However, after an experimental surgery more than three years ago, this 42-year-old is now the mother to an energetic 6-year-old, has re-entered the workforce and is learning to reclaim her life.

Unexpected seizures throw 30-year-old into coma

When Mengason had her first seizure, in January 2003, everything was going right with her life, she said. She was 33, living in Maryland, working in PR at a major health care company and was planning a May wedding to her new fiancé, Andrew.

Then, she began feeling sick. “I was planning a gigantic meeting (at the time), so I thought I had the flu,” she said. “I was working pretty hard.”

Then, one night while she was sleeping, she had a grand mal seizure. According to the the Epilepsy Foundation of Michigan, a grand mal seizure involves a period of rigidity, muscle jerks, shallow breathing and the loss of control over certain bodily functions.

At the time, however, Mengason said her fiancé didn’t know what to think. “He thought I was having a heart attack,” she said.

After having four more seizures that evening, Mengason slipped into a coma. When doctors couldn’t figure out what was happening to her, Mengason’s mother immediately flew her to William Beaumont Hospital in Royal Oak. Mengason grew up in Birmingham, she said, and her mother still lived in Beverly Hills.

Beaumont doctors said her seizures had been brought on by a bout with meningitis — a diagnosis that would later turn into epilepsy. However, upon waking up from her coma, Mengason had suffered severe short-term memory loss going back three years.

Suddenly, Mengason said, she didn’t know who her fiance Andrew was. She didn’t know what September 11 was. She didn’t know what she did for a living or that her father was dead.

Mengason never regained those memories, a fact she had to accept during the next nine months of rehabilitation and therapy.

“I had to realize I wouldn’t remember my father dying,” she said.

Surgeries prove unsuccessful

But life moved on for Mengason. After initially canceling her wedding, she and Andrew later tied the knot in Puerto Rico. She slowly relearned her job, often times conducting therapy sessions at the office. In 2006, she and Andrew worked with doctors so they could have their first child, Hayden.
Still, Mengason continued to have seizures, as many as 20 a week. During the next few years, Mengason said she tried dozens of options, including the high-fat, ketogenic diet (typically used to treat children with epilepsy).

In 2006, Mengason also underwent a series of surgeries to determine if she was a candidate for brain surgery. During the process, doctors would use stress, sugar and lack of sleep to trigger Mengason’s seizures while they monitored her brain activity.

It was then that doctors discovered the seizures were originating from both sides of her brain — making her ineligible for a risky surgery that would have removed parts of her brain.

“I was deemed high functioning,” Mengason said. “They didn’t want me to lose my cognitive skills or my balance.”

New treatment 'changes my life'

In June 2007, Mengason and her family moved back to Birmingham. While her husband went to work at a textile restoration company in Berkley, Mengason began seeing more doctors.

According to Mengason, she knew she had to do whatever she could to reclaim her life from the seizures.

“I knew that my memory was getting worse,” she said. “I wanted to continue working. I had a family now. I wanted to see what we could do.”

That’s when she started seeing Dr. Aashit Shah, a Wayne State University professor and neurologist at the Detroit Medical Center's Harper Hospital who specializes in epilepsy.

Mengason said Shah convinced her to try surgery again, but this time vagus nervestimulation (VNS) therapy.

Often referred to as a pacemaker for the brain, VNS therapy involves inserting a small pulse generator in one’s chest. This generator — about the size of a silver dollar — sends mild, intermittent doses of electrical stimulation to the left vagus nerve in the neck every 55 seconds.

According to Shah, VNS therapy can be effective for epilepsy patients when medication doesn't seem to work.

"When you try one, two, three medications and they don’t help patients, or patients who can’t be helped with surgery, this is an option," he said.

“It feels like a tug on your vocal cords,” Mengason added. “It’s a noticeable tinge as it sends charges to your brain.”

Since she started using the VNS therapy in 2009, these pulses have kept her seizures in check, Mengason said. She has fewer seizures a week, her seizures are less intense and her recovery time has improved dramatically.

“My doctor told me, ‘you have nothing to lose, and plenty to gain,'” said Mengason. “For me, the answer was simple — let’s give this a try … (Now), this device has changed my life.”

Living with no regrets, sharing her story

Now, years after the VNS device was implanted in her chest, life moves at an everyday pace for Mengason and her family.

Occasionally, it is interrupted by seizures, but Mengason said she only has two to three grand mal seizures a year now. She also believes her seizures have grown shorter.

Mengason is also working full time in the PR department of a downtown hospital. Two days a week, she works from home while a friend drives her down the other three days. Because of her condition, Mengason can’t drive.

According to Mengason, she is also unable to lay flat on her back, can’t do yoga, has to sit up at the dentist’s office and had to abandon a former hobby — skiing — for fear of falling and jarring the VNS device.

She’s also had to make accommodations with her daughter, Hayden. Mengason said she’s made friends who drive her daughter to school at Cranbrook’s Brookside School everyday. And even though she’s only 6, Hayden knows what to do in case mom has a seizure.

“She knows to call 911 and then her dad,” Mengason said. “And my mom is just over in Beverly Hills.”

What Mengason doesn’t do is live with regrets.

"I have my moments,” she admitted. “But I didn’t cause this, so I try not to feel sorry for myself.”
She’s also working to improve the lives of Michigan’s epilepsy patients through her work volunteering with the Epilepsy Foundation of Michigan.

“Seizures are kind of an ugly thing,” she said. “People are afraid of them … Having the kind of epilepsy that isn’t addressed well with medications is very scary and at times can feel hopeless. If I can share my story to give someone living with epilepsy hope and let them know VNS therapy is an available option, that’s huge.”

Mengason blogs at For more information on living with epilepsy and a breakdown of the various kinds of seizures, visit the Epilepsy Foundation of Michigan. For more information on VNS therapy, talk to your doctor or visit

Sunday, May 6, 2012

When illness makes a spouse a stranger

When illness makes a spouse a stranger

Rare ailment, frontotemporal dementia, has no cure or treatment    

Video: NYT: When illness makes a spouse a stranger

Béatrice de Géa for The New York
Michael French, 71, of Manhattan, has a rare brain disease, frontotemporal dementia, that strips away personality and language. His wife, Ruth, has struggled to care for him.
updated 5/6/2012 2:33:11 PM ET2012-05-06T18:33:11
He threw away tax documents, got a ticket for trying to pass an ambulance and bought stock in companies that were obviously in trouble. Once a good cook, he burned every pot in the house. He became withdrawn and silent, and no longer spoke to his wife over dinner. That same failure to communicate got him fired from his job at a consulting firm.

By 2006, Michael French — a smart, good-natured, hardworking man — had become someone his wife, Ruth, felt she hardly knew. Infuriated, she considered divorce.

But in 2007, she found out what was wrong.

“I cried,” Mrs. French said. “I can’t tell you how much I cried, and how much I apologized to him for every perceived wrong or misunderstanding.”

Mr. French, now 71, has frontotemporal dementia — a little-known, poorly understood and frequently misdiagnosed group of brain diseases that eat away at personality and language. Although it was first recognized more than 100 years ago, there is still no cure or treatment, and patients survive an average of only eight years after the diagnosis.

But recently, researchers have been making important discoveries about the biochemical and genetic defects that cause some forms of the disease. And for the first time, they have identified drugs that may be able to treat one of those defects, the buildup of abnormal proteins in the brain. Tests in people, the first ever such drug trials in this disease, could begin as soon as early next year at the University of California, San Francisco.

“There’s really been an explosion related to the biology,” said Dr. Bruce L. Miller, a professor of neurology and psychiatry there. “I think at least some subtypes of frontotemporal dementia will be the first neurodegenerative diseases we find a cure for.”

This disease is different from Alzheimer’s, the most common form of dementia. But it is perhaps even more devastating, because it strikes younger people, progresses faster and, unlike Alzheimer’s, does not attack memory at first but begins with silence, apathy or bizarre personality changes. It is thought to afflict at least 50,000 to 60,000 people in the United States.

The scientific findings in frontotemporal dementia may also reshape thinking about the fundamental flaws involved in Alzheimer’s disease.

“I think the way dementia is going in general now is to realize there are many different subtypes,” Dr. Miller said, adding that what is now labeled Alzheimer’s disease may actually turn out to include hundreds of different illnesses.

Dementia is a formidable adversary, and the history of efforts to treat Alzheimer’s has to temper any excitement about potential medicines for frontotemporal disease. The drugs for Alzheimer’s have been a disappointment, with just temporary effects on symptoms at best.

But even if treatments or cures for frontotemporal dementia do emerge, they will almost certainly come too late for people with advanced cases, like Mr. French or Richard Rainwater, a billionaire investor who learned in 2009 that he had progressive supranuclear palsy, which some consider a form of frontotemporal dementia. Mr. Rainwater and his family have donated more than $20 million to a research consortium, but given that he has a rapidly progressive form, any advances from the consortium may be more likely to help others than to save him.

Looking for Answers

Looking back, Mrs. French, who is 66 and lives in Manhattan, recalled episodes of odd behavior over the years and realized that her husband’s mind had probably begun to slip while he was in his 50s, at least a decade before the disease was diagnosed. He had always changed jobs a lot. At the time she took it as a sign of a stubborn personality, not of illness — and it is still not clear which it was. He always wanted to do things his own way, and that did not sit well with some bosses.

“I thought it was just Michael being Michael,” she said.

A friend described Mr. French as being unable to read the tea leaves, oblivious of corporate politics. At one point Mrs. French even bought him a self-help book. But he never changed.

And he always found another job, better than the one before. But things went downhill in 2006.

“His immediate boss was so frustrated by him that she called up, and we were at the dinner table, and I could hear her screaming,” Mrs. French said.

He was fired, and this time he did not find another job. At 66, he retired.

Soon after, because he had trouble speaking, he consulted a neurologist. When they got the diagnosis, Mrs. French asked the doctor, “How do we treat it?”

“It’s brain atrophy,” he replied.

Her thoughts of divorce evaporated. Instead, she told her husband: “Whatever happens, we will go through this together. I will be there.”

From then on, the silence at the dinner table no longer troubled her. It did not seem personal anymore. He was not refusing to talk; he simply could not. Her anger melted into sadness.

But sometimes she still blew her top. Once, she came home and found him at the stove, seemingly unaware that his oven mitt was smoldering.

“I actually hit him a couple times out of frustration,” she said. What made her lose control, she said, was a toxic mix of frustration and fear — fear of what was happening to him, and fear that she would not know what to do, how to help. No amount of information from his doctors could put her at ease.

“They can tell you everything that’s ever happened to anyone, but they can’t tell you what’s going to happen to you,” she said.
The last five years have been wrenching and often lonely. Michael was the love of her life. When she married him, her sister asked, “How does it feel to hit the jackpot?” In more than 30 years of marriage, she never heard him say an unkind word about anyone. He was an engineer, lectured at conventions, did volunteer work, belonged to a history book club, ran marathons. Now he can no longer speak, read, write or walk.

If there is comfort anywhere for Mrs. French, it is in knowing one thing: she has kept her promise to be there.

The Science

Frontotemporal dementia, also called frontotemporal degeneration or Pick’s disease, refers to a group of diseases that destroy nerve centers in the frontal and temporal lobes — the home of decision-making, emotion, judgment, behavior and language. Some forms of the disease also cause movement disorders.

Most cases occur sporadically, in people with no family history of the illness — like Michael French — but a small percentage are inherited.

Patients generally receive from one to four misdiagnoses, and it may take years to finally get the right answer. Mistaken diagnoses can include Alzheimer’s disease, stroke, midlife crisis or psychiatric illnesses like depression, bipolar disorder, post-traumatic stress or anxiety. Many relatives of patients say doctors dismiss their reports of personality change. But it is real.

"They totally break down in their ability to connect with other people and care about them,” Dr. Miller said.

There are eight subtypes of frontotemporal degeneration, sorted by the symptoms they cause. Some affect behavior. Others, grouped under the heading primary progressive aphasia, affect language. Still others affect movement, leading to disorders that resemble Parkinson’s or Lou Gehrig’s disease (also called amyotrophic lateral sclerosis or A.L.S.).

But patients may match more than one category, and the subtype may change as the disease progresses.

“I see a lot who don’t present like the textbook,” said Dr. Edward Huey, an assistant professor of psychiatry and neurology at Columbia University Medical Center.

In most patients, MRI and other scans reveal shrinkage in the frontal and temporal lobes, sometimes to a shocking degree.

“If I showed you more extreme cases, you could read it from across the room,” Dr. Huey said.
He said researchers were using imaging to find out if specific symptoms could be mapped to atrophy in certain spots.

“The frontal lobes are sort of the last frontier in the brain,” Dr. Huey said, adding that the losses these patients suffer are helping researchers understand more about what the frontal lobes do. As the brain atrophy progresses, Dr. Huey said, patients “have pieces of psychiatric syndromes, but not the whole syndrome.” For instance, they have compulsions, but not the usual accompaniment, obsessions. So they may wash their hands over and over again, but not in a worried or anxious way. Some lose their inhibitions and moral judgment. Shoplifting is not uncommon. Many have the apathy and social disconnection that usually go with depression, but they do not feel depressed.

“They’re not down, but they just don’t enjoy things as much as they used to,” Dr. Huey said. “There appears to be a dysfunction in the reward circuit, where activities that were rewarding and pleasurable no longer seem to be. These patients lose themselves.”

Many seem to go on endless eating binges and gain weight. It is not clear why — whether they are actually hungry or whether the eating is just another compulsion. Some people with the illness shower repeatedly or check the mail 100 times a day. One possible reason, Dr. Huey said, is that “the part of the brain that tells you, ‘No, that task is done,’ is gone.” Some patients collect things — by the hundreds. A few have had bursts of creativity in music or painting, possibly because other brain regions come to the fore as the frontal lobes wither.

A Way of Life Cut Short

Long before her husband became ill, Mrs. French had a successful career in sales and marketing for textile companies and ultimately became a vice president at Liberty of London. But she gave it up in 1991 to do something she loved: teaching English as a second language to adults. She was doing that work when his condition was diagnosed.

One day, in a moment of inspiration, she asked her students if they knew the traditional wedding vows in English. She began to recite them. At “for better, for worse,” she choked up. Struggling to keep her composure, she quickly finished and moved on to another subject.

After teaching, she would walk home through Central Park, and in the early days of his illness Mr. French would often meet her halfway. She would see him heading toward her, smiling and strikingly handsome. “When I look at Michael, that’s what I see, that’s who he will always be to me.”

In 2007, Mrs. French joined a support group for caregivers of people with frontotemporal dementia. Jill Goldman, a genetic counselor at Columbia University Medical Center, said she started the group because patients’ relatives felt that they did not fit in at Alzheimer’s groups; their loved ones were younger and often had bizarre behaviors that were nothing like Alzheimer’s.

“One of the things that goes first is insight,” Ms. Goldman said. “‘There’s nothing wrong with me. Why can’t I do what I want to do?’ ”

Members of the group tell of loved ones who hug strangers, who fly into terrifying rages and hit family members and health aides, or who pass their days in silence cutting up newspapers or watching television. Patients are easily taken in by financial scams that can cost families thousands of dollars. Often, apathy sets in, and people once devoted to their families lose interest in everyone, even their own children.

“My son and I look out the window and see my wife out there, stepping on leaves, and we start to cry,” one member said.

Some have struggled with uncertain diagnoses because patients have symptoms of both Alzheimer’s and frontotemporal disease. One wife described trips to multiple doctors and inconclusive reports on PET scans and spinal taps. Should she have taken her husband to the Mayo Clinic? She agonized over the idea that he might have some illness other than frontotemporal dementia or Alzheimer’s, something treatable, and that there might be some way to rescue him, to bring him back.

Another said her husband, a judge who had always been mild-mannered and modest, turned boastful and began talking to strangers in the street, making jokes at the wrong time and falling for scams.
“He salutes every flag, closes every gate, kisses every hand,” she said.

Riding the bus in Manhattan, he will loudly announce, “I haven’t killed anybody lately.” Not infrequently it gets him a seat. He can turn violent and has struck a health aide with his cane.

“He’s just mean and nasty,” his wife said. “He was such a wonderful man. He’s not a person anymore.”

Ms. Goldman provides stacks of business-size cards that spouses can hand out to strangers in awkward situations.

“My husband has a terminal brain disease called frontotemporal dementia,” the cards read. “Thank you for your understanding.”

Many find that friends and family pull away. Nearly all grapple with whether and when to take away car keys, give drugs to blunt aggression, hire a health aide or put the patient in a nursing home. One group member said, “The doctor told me, ‘You’re taking good care of him, he’ll live a long time,’ and I said, ‘Why is that a good thing?’ ”

Patients are hard to care for at home, and those who are young, strong and aggressive are sometimes kicked out of nursing homes because they are seen as posing a physical threat. But employers do not necessarily sympathize with relatives called out of work in the middle of the day because a patient has punched or shoved someone at the nursing home.

“My boss says, ‘You just have to deal with this better,’ ” one group member said.

Another group member, a professor of psychotherapy and mental health counseling, said she quit her job at the height of her career to take care of her partner and after a few years became suicidal.
“Being a caregiver in this disease is a grieving process,” she said, “while the person is still alive.”

Easing the Burden

Ruth and Michael French managed on their own until May 2009, when he fell down a flight of stairs in their apartment building while she was at work. He fractured his skull and came home in a wheelchair, so weak and frail that she hired an aide to help take care of him.

Mrs. French is fine-boned and thin, and as her husband grew weaker, the physical demands on her became daunting. Streets she had thought flat revealed themselves to be hills once she found herself trying to push a 140-pound man in a wheelchair. Potholes yawned like chasms. One night at home, after helping him clean his teeth, she turned to put the toothbrush away, and in that moment he fell into the bathtub. She was barely able to pull him up.

“I said, ‘Michael, now we’re at the point where we’re both at risk,’ ” she recalled.

She injured her wrist, developed a stomach ulcer and lost so much weight that people worried about her. Mr. French became incontinent, and she would sometimes wake up in a pool of his urine. The health aide hurt her back lifting him.

“I heard myself say one day, ‘I would never want anybody to do for me what I’m doing for Michael,’ ” Mrs. French said.

She had hoped to keep him at home until the end but knew it might not be possible. “This thing is going to kill both of us, and I don’t know who’s going first,” she told him.

In one way, she had an easier time than many other caregivers. Her husband never turned hostile. He retained a sweetness, and an acceptance of his illness that she found inspiring.

At one point, worried about finances, she considered laying off the aide and taking care of Michael alone. When members of her support group worried that the stress would kill her, she told them, “That might not be so bad.”

At Ms. Goldman’s urging, she saw a psychotherapist. He recommended medications to calm her. She filled the prescription but threw the pills away.

“I kind of feel that having gone through the anxiety and the worry is what let me get to the other side,” Mrs. French said.

While Mr. French was still well enough, they had discussed the possibility of a nursing home. So when the time came, it was not really a surprise.

“He knew it was something I didn’t want to do, because every time we spoke about it I would cry,” Mrs. French said. “When I told him that I had made arrangements, he said — and this is a man who can’t speak, so he had to muster every bit of energy he could — he said, ‘You did the best you could.’ ”

In April last year, Mrs. French placed her husband in a nursing home in Manhattan. Along with her sadness came feelings of relief and freedom. Soon after he was settled, she went out to dinner with friends for the first time in two years.

“At times, I ache for him to be back in the apartment,” she said. “But I ache for him to be back as him.”

She said that long after he ceased speaking, he continues to understand what she says.
“I remember asking his neurologist, ‘Will he know me?’ ” Mrs. French said. “And he said, ‘Oh, he’ll always know you. He might not be able to express it in a way that will be familiar to you or that you’ll like, but he’ll always know you.’ ”

She wondered what longings might drive her husband’s dreams:

“I asked him, ‘Do you talk in your dreams?’ and he said, ‘Yes.’ And I asked him, ‘Do you dream about me?’ And he said, ‘Yes.’ ”

She has had time to think about mortality, his and her own.

“Death to me has always been a wake-up call to live,” she said. “This is the endgame. Sometimes I get upset because I don’t think I have enough money, and sometimes I get upset because I think I do. You don’t necessarily want to live too long, but neither do you want to die.”

On most days, she spends several hours at the nursing home with her husband. She shaves him and sometimes climbs into bed with him to hold him and to nap together.

“Where do you carry my heart?” she asks him, referring to a poem they love by E. E. Cummings.
He smiles and pats his chest.

i carry your heart with me(i carry it in
my heart)i am never without it(anywhere
i go you go,my dear;and whatever is done
by only me is your doing,my darling)
i fear no fate(for you are my fate,my sweet)i want
no world(for beautiful you are my world,my true)

Excerpt reprinted from “Complete Poems: 1904-1962” by E. E. Cummings, ed. George J. Firmage. With the permission of the Liveright Publishing Corporation.
This story, "When Illness Makes a Spouse a Stranger," was originally published in The New York Times.

Wednesday, May 2, 2012

Vagus nerve stimulation in children with intractable epilepsy: a randomized controlled trial.

Dev Med Child Neurol. 2012 Apr 28. doi: 10.1111/j.1469-8749.2012.04305.x. [Epub ahead of print]

Vagus nerve stimulation in children with intractable epilepsy: a randomized controlled trial.


Department of Neurology, Maastricht University Medical Center, Maastricht  School for Mental Health & Neuroscience, Maastricht  Department of Neurosurgery, Maastricht University Medical Center, Maastricht  Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht  Epilepsy Center Kempenhaeghe, Heeze, the Netherlands.


Aim  The aim of this study was to evaluate the effects of vagus nerve stimulation (VNS) in children with intractable epilepsy on seizure frequency and severity and in terms of tolerability and safety. Method  In this study, the first randomized active controlled trial of its kind in children, 41 children (23 males; 18 females; mean age at implantation 11y 2mo, SD 4y 2mo, range 3y 10mo-17y 8mo) were included. Thirty-five participants had localization-related epilepsy (25 symptomatic; 10 cryptogenic), while six participants had generalized epilepsy (four symptomatic; two idiopathic). During a baseline period of 12 weeks, seizure frequency and severity were recorded using seizure diaries and the adapted Chalfont Seizure Severity Scale (NHS3), after which the participants entered a blinded active controlled phase of 20 weeks. During this phase, half of the participants received high-output VNS (maximally 1.75mA) and the other half received low-output stimulation (0.25mA). Finally, all participants received high-output stimulation for 19 weeks. For both phases, seizure frequency and severity were assessed as during the baseline period. Overall satisfaction and adverse events were assessed by semi-structured interviews. Results  At the end of the randomized controlled blinded phase, seizure frequency reduction of 50% or more occurred in 16% of the high-output stimulation group and in 21% of the low-output stimulation group (p=1.00). There was no significant difference in the decrease in seizure severity between participants in the stimulation groups. Overall, VNS reduced seizure frequency by 50% or more in 26% of participants at the end of the add-on phase The overall seizure severity also improved (p<0.001). Interpretation  VNS is a safe and well-tolerated adjunctive treatment of epilepsy in children. Our results suggest that the effect of VNS on seizure frequency in children is limited. However, the possible reduction in seizure severity and improvement in well-being makes this treatment worth considering in individual children with intractable epilepsy.

© The Authors. Developmental Medicine & Child Neurology © 2012 Mac Keith Press.
PMID: 22540141 [PubMed - as supplied by publisher]