Cyberonics reneged on its "Lifetime Reimbursement Guarantee". Click on the image to learn how you can help...

Thursday, April 25, 2013

Transcranial magnetic stimulation benefits in Parkinson’s disease

Transcranial magnetic stimulation benefits in Parkinson’s disease

Published on April 25, 2013 at 9:15 AM        

By Eleanor McDermid, Senior medwireNews Reporter

A course of low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) improves motor symptoms in patients with Parkinson's disease (PD), shows results from a randomized controlled trial.

The effects lasted for at least 3 months after treatment, making rTMS of the SMA a "good candidate as an add-on therapy" for patients with PD, say lead researcher Yuichiro Shirota (The University of Tokyo, Japan) and colleagues.

The benefit was also seen over and above the placebo response to rTMS. The researchers stress the importance of having a "realistic" sham rTMS treatment, which reproduces the sensation on the skin and also the clicking sound of genuine treatment. By week 9, which was 1 week after the conclusion of the 8-week treatment period, sham treatment of 34 patients produced an average 4.03-point improvement in the primary endpoint of change on the Unified Parkinson's Disease Rating Scale (UPDRS) part III.

The 34 patients given low-frequency (1 Hz) rTMS had a 4.91-point improvement in the primary endpoint and the 34 given high-frequency (10 Hz) rTMS had a 4.71-point improvement. The were no significant differences between the groups, which the team attributes to a "substantial sham effect" concealing the true benefits of treatment.

The effect of sham treatment had largely disappeared by 20 weeks after treatment, with these patients' UPDRS part III scores improved by an average of 2.71 points relative to baseline. By contrast, the average score in patients given low-frequency rTMS was 6.84 points improved from baseline, and this change was significantly better than that in the sham rTMS group. There were no improvements in nonmotor symptoms, apathy, or depression, however.

At week 20, the average UPDRS part III score in patients given high-frequency rTMS was just 0.71 points lower than at baseline. "Because the time course of change in UPDRS part III score was similar to that in the sham group, the transient improvement was likely caused by a nonspecific, placebo-like effect," write Shirota et al in Neurology.

They note that low- and high-frequency rTMS are thought to work by suppressing and stimulating brain activity, respectively. The benefits of low-frequency stimulation of the SMA are therefore in line with the benefits of deep-brain stimulation of the subthalamic nucleus, which also appears to result in reduced activity in the SMA.

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Tuesday, April 23, 2013

NIH Shines a Bright Light on Cocaine Addiction

NIH Shines a Bright Light on Cocaine Addiction

Optogenetic stimulation using laser pulses lights up the prelimbic cortex.
Optogenetic stimulation using laser pulses lights up the prelimbic cortex. Courtesy of Billy Chen and Antonello Bonci

By Dr. Francis Collins
  • National Institutes of Health
  • 3:00 PM ET

  • By Dr. Francis Collins
    April 23, 2013

    Wow—there is a lot of exciting brain research in progress, and this week is no exception. A team here at NIH, collaborating with scientists at the University of California in San Francisco, delivered harmless pulses of laser light to the brains of cocaine-addicted rats, blocking their desire for the narcotic.

    If that sounds a bit way out, I can assure you the approach is based on some very solid evidence suggesting that people—and rats—are more vulnerable to addiction when a region of their brain in the prefrontal cortex isn’t functioning properly. Brain imaging studies show that rat and human addicts have less activity in the region compared with healthy individuals; and chronic cocaine use makes the problem of low activity even worse. The prefrontal cortex is critical for decision-making, impulse control, and behavior; it helps you weigh the negative consequences of drug use.

    Addiction is an enormous public health issue. Currently, 1.4 million Americans are addicted to cocaine—and no treatment has been approved by the U.S. Food and Drug Administration, making it one of the National Institute on Drug Abuse’s top research priorities.

    So let me first say that nerve cells, or neurons, don’t typically respond to laser beams. The rats in this experiment were engineered to carry light-activated neurons within a part of their prefrontal cortex called the prelimbic cortex. The rats were then fitted with optic fibers to transmit the laser pulses.

    This technique, called optogenetics, was actually invented by a recipient of the NIH’s Pioneer Award, and it will likely contribute significantly to the BRAIN initiative just announced by President Obama.
    The researchers studied rats that were chronically addicted to cocaine. Their need for the drug was so strong that they would ignore electric shocks in order to get a hit. But when those same rats received the laser light pulses, the light activated the prelimbic cortex, causing electrical activity in that brain region to surge. Remarkably, the rat’s fear of the foot shock reappeared, and assisted in deterring cocaine seeking. On the other hand, when the team used a different optogenetics technique to reduce activity in this same brain region, rats that were previously deterred by the foot shocks became chronic cocaine junkies.

    Clearly this same approach wouldn’t be used in humans. But it does suggest that boosting activity in the prefrontal cortex using methods like transcranial magnetic stimulation (TMS), which is already used to treat depression, might help. In fact, clinical trials at the NIH are scheduled to begin soon.

    The researchers plan on using TMS to bump up activity in the prefrontal cortex and see if it decreases addictive behaviors in people.

    Francis S. Collins, M.D., Ph.D. is the Director of the National Institutes of Health (NIH). In that role he oversees the work of the largest supporter of biomedical research in the world, spanning the spectrum from basic to clinical research. Dr. Collins is a physician-geneticist noted for his landmark discoveries of disease genes and his leadership of the international Human Genome Project, which culminated in April 2003 with the completion of a finished sequence of the human DNA instruction book. He served as director of the National Human Genome Research Institute at the NIH from 1993-2008.

    Efficacy of vagus nerve stimulation in brain tumor-associated intractable epilepsy and the importance of tumor stability.

    2013 Apr 19. [Epub ahead of print]

    Efficacy of vagus nerve stimulation in brain tumor-associated intractable epilepsy and the importance of tumor stability.


    Departments of Neurological Surgery.


    Object Vagus nerve stimulation (VNS) is a viable option for patients with medically intractable epilepsy. However, there are no studies examining its effect on individuals with brain tumor-associated intractable epilepsy. This study aims to evaluate the efficacy of VNS in patients with brain tumor-associated medically intractable epilepsy. Methods Epilepsy surgery databases at 2 separate epilepsy centers were reviewed to identify patients in whom a VNS device was placed for tumor-related intractable epilepsy between January 1999 and December 2011. Preoperative and postoperative seizure frequency and type as well as antiepileptic drug (AED) regimens and degree of tumor progression were evaluated. Statistical analysis was performed using odds ratios and t-tests to examine efficacy. Results Sixteen patients were included in the study. Eight patients (50%) had an improved outcome (Engel Class I, II, or III) with an average follow-up of 39.6 months. The mean reduction in seizure frequency was 41.7% (p = 0.002). There was no significant change in AED regimens. Seizure frequency decreased by 10.9% in patients with progressing tumors and by 65.6% in patients with stable tumors (p = 0.008). Conclusions Vagus nerve stimulation therapy in individuals with brain tumor-associated medically intractable epilepsy was shown to be comparably effective in regard to seizure reduction and response rates to the general population of VNS therapy patients. Outcomes were better in patients with stable as opposed to progressing tumors. The authors' findings support the recommendation of VNS therapy in patients with brain tumor-associated intractable epilepsy, especially in cases in which imminent tumor progression is not expected. Vagus nerve stimulation may not be indicated in more malignant tumors.
    [PubMed - as supplied by publisher]

    Thursday, April 18, 2013

    NeuroStar TMS Therapy, a Non-Drug Depression Treatment, Demonstrates Statistically Significant Benefits on Patient-Reported Pain Outcomes

    PR Newswire  

    NeuroStar TMS Therapy, a Non-Drug Depression Treatment, Demonstrates Statistically Significant Benefits on Patient-Reported Pain Outcomes

    Study Participants Experienced Improvement in Pain and Well-Being that Persisted Through One Year

    SAN DIEGO, March 19, 2013 /PRNewswire/ -- New data released today at the annual meeting of the American Academy of Neurology show that transcranial magnetic stimulation (TMS) administered using the NeuroStar TMS Therapy System® significantly reduced pain-related symptoms in patients with Major Depressive Disorder (MDD), with improvement sustained through one year.  Pain-related symptoms are present in more than 75 percent of patients living with depression, indicating a need to offer patients effective treatment options.
    "A majority of people living with depression experience pain-related symptoms, which often interfere with patients' quality of life and may result in greater treatment costs," said Dr. Mark George , M.D., Director of the Brain Stimulation Laboratory at the Medical University of South Carolina. "The data in this preliminary study indicate that TMS may serve as a promising, effective, non-drug option to relieve symptoms of moderate to extreme pain in patients with MDD without the systemic side effects of oral medications."  
    In this subset analysis of a Neuronetics-sponsored multisite, naturalistic, observational study involving 42 TMS clinical practice sites based in the United States, 307 outpatients with a primary diagnosis of MDD were treated with NeuroStar TMS Therapy and received an average of 28 TMS sessions during acute treatment.  Investigators evaluated improvement in pain measures using two quality of life instruments, the EuroQol Questionnaire (EQ-5D) and the Short Form 36-Item Questionnaire (SF-36).
    At baseline, 47.1 percent of patients indicated moderate pain and discomfort while 11.7 percent of patients indicated extreme pain and discomfort, which decreased significantly by the end of acute treatment to 41.4 percent and 6.6 percent of patients, respectively. The improvement in the percent of patients reporting extreme pain and discomfort was sustained through 12 months of follow-up, demonstrating durability in the most extreme pain cases.
    The percentage of patients reporting general pain-related problems significantly reduced from 58.8 percent at baseline to 48 percent at the end of acute treatment, as measured by the EQ-5D. In addition, the SF-36 bodily pain scores improved significantly following acute NeuroStar TMS Therapy from 44.5 to 48.1, which persisted through 12 months. There was a significant correlation between the improvement of the SF-36 bodily pain scores and the improvement of depressive symptomatology, as measured by the Patient Health Questionnaire (PHQ-9).
    About NeuroStar TMS Therapy®
    Neuronetics' NeuroStar TMS Therapy System was cleared by the FDA in October 2008 for the treatment of Major Depressive Disorder (MDD).  NeuroStar TMS Therapy is indicated for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. NeuroStar TMS Therapy is a non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation.  It stimulates nerve cells in an area of the brain that has been linked to depression by delivering highly-focused MRI-strength magnetic field pulses. The treatment is available by prescription and typically administered daily for 4-6 weeks.  For full safety and prescribing information, visit
    About Depression
    Depression is a serious illness that affects about 20 million Americans annually.  People with depression may experience a range of physically and emotionally debilitating symptoms, including anxiousness, sadness, irritability, fatigue, changes in sleep patterns, loss of interest in previously enjoyable activities and digestive problems.  It is estimated that about four million patients do not benefit from standard treatments for depression, even after repeated treatment attempts. 
    About the StudyThis study was designed to assess patient-reported pain outcomes following Transcranial Magnetic Stimulation (TMS) treatment for major depression disorder (MDD) in clinical practice. Three hundred and seven depressed patients were part of a prospective, multi-site, observational clinical trial studying the utilization and outcomes of the NeuroStar TMS Therapy system in naturalistic clinical practice. Patients who received benefit from acute TMS treatment (N= 257) consented to long-term follow up over 12 months, and were evaluable for statistical analysis. The objectives of the study were to assess the change in depressive symptomatology and functional capacities across the duration of the study. Data for the pain domains in the Short Form 36-Item Questionnaire (SF-36) and the EuroQol Questionnaire (EQ-5D) were collected at baseline, end of acute treatment (EOA), 3-, 6-, 9-, and 12-months follow-up, in order to evaluate the effect of NeuroStar TMS therapy on pain in patients with MDD.
    About Neuronetics, Inc.Neuronetics, Inc., is a privately-held medical device company focused on developing non-invasive therapies for psychiatric and neurological disorders using MRI-strength magnetic field pulses.  Based in Malvern, PA, Neuronetics is the leader in the development of TMS Therapy, a non-invasive form of neuromodulation.  For more information, please visit
    NeuroStar®, NeuroStar TMS Therapy® and TMS Therapy® are registered trademarks of
    Neuronetics, Inc.

    SOURCE Neuronetics, Inc.

    Wednesday, April 17, 2013

    'Pacemakers for brain' offer new treatment options for depression at N.J. center

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    'Pacemakers for brain' offer new treatment options for depression at N.J. center
    April 17, 2013
    By Maiken Scott @maikenscott

    A new University of Medicine and Dentistry of New Jersey center in Cherry Hill offers a slew of cutting-edge options for people with depression and anxiety who have not responded to medications, or can't tolerate the side effects.

    At the Center for Mood Disorders and Neuromodulation Therapies, psychiatrist John O'Reardon reclined on a comfy chair to test a transcranial magnetic stimulation machine. When a patient is in the chair, a wand hovers close to their head and delivers weak electric currents to jolt specific regions of the brain into action.

    The center specializes in different forms of brain stimulation techniques, which director O'Reardon likens to advances in another medical field.

    "This is the same as cardiology ... cardiology had medications, but they didn't have pacemakers or stents," explained O'Reardon. "Once they had devices for the heart, they advanced greatly. These are devices for the brain -- they are pacemakers for the brain."

    Different types of brain stimulation, under study since the mid-'90s, have shown strong results in treating those with severe depression, anxiety, and obsessive compulsive disorder. TMS, which as been approved by the Food and Drug Adminstration, is covered by Medicare and some insurance companies.

    These treatments have a major advantage compared with medications; they have no side effects.
    "The brain is like a large soup the medications go into, and they go everywhere and they give you side effects," O'Reardon said. "Here, we are targeting just 1 centimeter on the cortex."

    In addition to offering a variety of brain stimulation treatments, the center also will conduct research studies.

    O'Reardon is currently testing the effectiveness of an at-home device for TMS called Synchronized TMS. A patient comes in for an EEG; the levels on the device are set accordingly; then the patient takes it home and comes back for monitoring, he explained. O'Reardon says that trial will be complete in three months.

    The center also offers a treatment called transcranial direct current stimulation or tDCS, which has shown promising results in several research studies.

    Going forward, O'Reardon said, these new approaches will become more widely available to people suffering from mental illness. "The hope is to have a suite of devices, and that everybody can get better," he said.

    The center at 2250 Chapel Ave. West, Cherry Hill, will host an open house Friday from 11 a.m. to 1 p.m.

    Monday, April 15, 2013

    Device Helps Scott Depot Woman Lead Seizure-Free Life


    Device Helps Scott Depot Woman Lead Seizure-Free Life

    Reported by: Send eMail Darrah Wilcox
    Web Producer: Heath Harrison
    Reported: Apr. 14, 2013 6:32 PM EDT
    Updated: Apr. 15, 2013 1:51 AM EDT

     Scott Depot , Kanawha County , West Virginia 

    A woman in Scott Depot who was once crippled by seizures is now living a full seizure-free life with the help of an implanted device.

    In hopes of helping others with the same debilitating diagnosis, she wanted to share her story.

    Elizabeth Haught was only a few months old when she started having seizures.

    "It was just real difficult,” Haught said. “My life was real difficult before."

    Elizabeth is one of more than 2 million Americans living with epilepsy. Dr. Ijaz Ahmad treats many patients with neurological disorders, including Elizabeth, and said seizures are debilitating in countless ways.

    "A person doesn't know when they are going to have the next one, how bad it is going to be, it affects their social life, their education,” Ahmad said. “It affects their family life, plus the expense of treating these conditions is quite enormous not only financial but social psychological."

    At her peak, Elizabeth was having 50 to 100 seizures a day, and was in and out of Cincinnati Children's Hospital, and on a different medication about every year until her mid-teens.

    "She was really in lala land,” Elizabeth’s mom, Leigh Haught, said. "It hindered her development, her education, her social activities - everything that children her age should be doing she wasn't."

    After finding out she was not a good candidate for brain surgery, Elizabeth and her family decided to go a different route. Ten years ago, she had a VNS implant, or vagus nerve stimulation therapy, surgically put in.

    It's a pacemaker-like device for the brain.

    "It stopped the seizures dead in its tracks," Elizabeth Haught said.

    She said it changed nearly everything about her life.

    "I could actually get out and do things,” she said. “I did soccer. I did track."

    Now, she can hold a job and is even learning how to drive.

    "It's been great,” she said. “It's been absolutely awesome. I like to be able to travel, and I like to make necklaces just do all kinds of things I wasn't able to do before."

    Elizabeth Haught gets the device checked every few months, and she's decreased her medication from 28 pills a day to a more manageable six.

    "It has been a steady progress at least in my lifetime how the technology has evolved,” Ahmad said.

    Elizabeth and her mom are hoping to visit Israel together one day soon.

    CYBX Resumes Reimbursement Efforts

    Analyst Blog

    CYBX Resumes Reimbursement Efforts

    by Zacks Equity Research

    April 08, 2013 | Comments : 0
    Cyberonics (CYBX - Analyst Report) recently provided further information on its reimbursement claim submission to the Centers for Medicare & Medicaid Services (CMS). The leading player in the neuromodulation space is currently seeking reimbursement coverage for all treatment-resistant depression (TRD) indications for its well-regarded VNS Therapy System.

    Cyberonics provides VNS Therapy for the treatment of refractory epilepsy and TRD. The VNS Therapy System is delivered from a small pacemaker-like generator implanted in the chest that sends preprogrammed, intermittent, mild electrical pulses through the vagus nerve in the neck to the brain.

    The VNS Therapy System was approved as treatment for TRD in 2001 in Europe and Canada.  Subsequently, the system received approval in the U.S. (for patients of 18 years or above) in Jul 2005. Regulatory bodies in the European Economic Area, Canada and Israel also approved the system for patients without age restrictions.

    However, Cyberonics no longer actively sells or markets the product for depression in the U.S. market due to reimbursement issues following CMS determination of non-coverage of VNS Therapy for patients with TRD. The company also does not actively market VNS Therapy for TRD in Europe and Canada.

    Earlier, Cyberonics submitted an appeal to reconsider reimbursement coverage for VNS Therapy for TRD to CMS. Subsequent to the request, the company expected some form of formal feedback from CMS, either affirmative or dissenting, before the end of Mar 2013. However, Cyberonics is yet to receive any acknowledgement from CMS to date.

    Although the company is still engaged in discussions with CMS to reconsider the request, the timing and result of the ongoing dialogue is uncertain. Nonetheless, Cyberonics is optimistic about securing reimbursement coverage for VNS Therapy for TRD on the back of positive clinical outcomes obtained in the last five years. We believe that the reimbursement coverage for TRD indication is likely to garner incremental revenues in the U.S. as well as in the international market.

    Uptrend in the core epilepsy business, pipeline development, strategic investments and consistently impressive quarterly performance reflects the strong growth potential of Cyberonics. Accordingly, the stock carries a Zacks Rank #1 (Strong Buy). Other Zacks Rank #1 medical stocks are Cepheid (CPHD - Analyst Report), Given Imaging (GIVN - Snapshot Report) and Medical Action (MDCI - Snapshot Report).

    We now know that many disorders are physiological, not psychological

    An image of tractography, a technique that tracks the movement of water molecules in the brain to create a 3-D map of its highly complex network of axons. By tracking these pathways, MUSC researchers are studying brain disorders including ADHD and Alzheimer's disease. The colors represent the direction water molecules are moving.

    We now know that many disorders are physiological, not psychological

    • Posted: Sunday, April 14, 2013 12:01 a.m.
      UPDATED: Sunday, April 14, 2013 9:42 a.m.
    • Text size: A A A
    Exhaustion weighs her down until she gets out of bed. Trudging to the shower and going down the grocery store aisles feel like a long slog through dark molasses.

    By the numbers

    Who are the mentally ill? They are our neighbors, friends, family — and us. Put five people in a room and one has suffered from a mental illness in the past year. One in five adults (46 million Americans) experiences mental illness each year. One in 17 suffers serious mental illness such as schizophrenia, major depression or bipolar disorder.One in 10 children lives with a serious mental or emotional disorder. The rate of mental illness is more than twice as high among those aged 18 to 25 (29.9 percent) than among those 50 and older. Less than one-third of adults and half of children with a diagnosable mental disorder receives mental health care in a given year. Half of all lifetime cases of mental illness begins by age 14, three-quarters by 24. More than 50 percent of students 14 and older with a mental disorder drop out of high school — the highest dropout rate of any disability group. 24 percent of state prisoners and 21 percent of local jail prisoners have a recent history of mental illness. 70 percent of children in juvenile justice systems have at least one mental disorder. The annual economic, indirect cost of mental illness in the U.S. is about $79 billion, mostly in lost productivity. Adults living with serious mental illness die 25 years earlier than other Americans, largely due to treatable medical conditions. An estimated 8.7 million American adults had serious thoughts of suicide in the past year. Of them, 2.5 million made suicide plans, and 1.1 million attempted suicide.

    Sources: Substance Abuse and Mental Health Services Administration, National Alliance on Mental Illness, National Institute of Health, U.S. Department of Health and Human Services, National Center for Mental Health and Juvenile Justice
    The heaviness caused by major depression has come and gone throughout Lisa Livingston Baker's life. And when her husband died in 2008, she could not even lift her body from her bed.

    Major mental illnesses

    Mental illness refers to a wide range of disorders that affect mood, thinking and behavior. More common ones include: Attention-deficit/hyperactivity disorder: Characterized by inattention, hyperactivity and impulsivity. Strong scientific evidence indicates ADHD is a biologically based disorder. Research also suggests a strong genetic basis. Bipolar disorder (formerly known as “manic-depressive disorder”): A major mood disorder in which a person experiences episodes of depression and mania (extreme irritability or euphoria). Likely caused by an imbalance of neurotransmitters or hormones. Trauma and major loss may play roles.Major depression (known as clinical depression): A combination of depressed mood, poor concentration, insomnia, fatigue, appetite disturbances, excessive guilt and suicidal thoughts. Depression is twice as common in women for reasons not fully understood. Likely caused by biological differences in the brain along with trauma or major loss. Post-traumatic stress disorder: Severe or repeated exposure to trauma can affect the brain in a way that makes a person feel like the event is happening again and again. Can induce anxiety, sleeplessness, anger or substance abuse. PTSD can affect everyone from survivors of sexual trauma and natural disasters to emergency and rescue personnel and military veterans. Generalized anxiety disorder: A severe, chronic, exaggerated worrying about everyday events. Likely caused by genetics, brain chemistry and environmental stresses. Obsessive-compulsive disorder: Obsessions are intrusive, irrational thoughts or impulses that repeatedly well up in a person's mind. Compulsions are repetitive rituals such as handwashing, counting, checking, hoarding or arranging. Evidence suggests that OCD is caused by a chemical imbalance in the brain. People whose brains are injured also can develop OCD. Panic disorder: Feelings of terror that strike suddenly and repeatedly with no warning. Symptoms include sweating, chest pain and irregular heartbeats. More common in women. Brain abnormalities, family history, major life stress and abuse of drugs and alcohol may play roles. Schizophrenia: A group of severe brain disorders in which people interpret reality abnormally. May result in hallucinations, delusions and disordered thinking and behavior. Likely caused by differences in the brain, genetic vulnerability and environmental factors that occur during a person's development. Personality disorders Borderline personality disorder: Characterized by unstable moods, interpersonal relationships, self-image and behavior. Antisocial personality disorder: A person's thinking and relating to others are abnormal and destructive, such as disregard for right and wrong, lying and behaving violently. Narcissistic personality disorder: Characterized by an inflated sense of self-importance and a deep need for admiration. Personality disorders are thought to be caused by genetic and environmental factors. Sources: National Alliance on Mental Illness, Mayo Clinic, WebMD
    She blamed herself.

    First in a series

    The mentally ill are under pressure and scrutiny like never before. Mental health budgets have been slashed. State inpatient beds are at historic lows. Emergency rooms and jails are the new front lines of care. In the wake of mass shootings — and would-be school shooters such as Alice Boland — some want registration of the severely ill. But there is promise for change. State funding may increase. Research is showing these illnesses are based in flawed physiology, not character flaws. And many who suffer are challenging the stereotypes that affect them. The Post and Courier is examining these issues in a series of stories over the next few months. We start with the stigma and its undercurrent of shame.

    Join the discussion about this story and other mental health issues at Jennifer Berry Hawes' Facebook group.
    The master's-educated teacher struggled to raise her three girls as she took medications and entered therapy. Books and tapes about coping amassed beneath her bed.
    “I've done it all,” the Summerville mom sighed. “And how many more Lisas are out there?”
    Millions. One in four adults experiences mental illness in a given year. One in 17 suffers serious mental illness such as schizophrenia, major depression or bipolar disorder, according to the U.S. Department of Health and Human Services.
    And at perhaps no other time have they received more public attention than today.
    Megachurch Pastor Rick Warren's son committed suicide a week ago after a long battle with major depression.
    Lawmakers are debating mental health care funding, gun control and registries of the mentally ill. And last week, 9th Circuit Solicitor Scarlett Wilson voiced doubt that the state can fully rehabilitate the violent mentally ill.
    What does all this attention mean for the average person with a mental illness, suffering amid a public that stigmatizes them?
    Baker can't count how often she's heard:
    Buck up. Get over it. Just cheer up!
    “People make you feel bad about yourself — and you make you feel bad about yourself,” Baker said. “I'm not a bad person. I'm not lazy or weak. I'm a good person. I'm trying.”
    She recently joined a clinical trial at the Medical University of South Carolina that administers a brain stimulation treatment based on researchers' improving knowledge of the brain as a highly complex electro-chemical organ, one that can malfunction just like any body part.
    After receiving most of her treatments, Baker can laugh again. She even tackled her taxes.
    And it's not just the relief. The boost proves to her that the depression is caused not by personal failure, as stigma insinuates, but rather by malfunctioning brain circuitry.
    It's proof that the illness isn't her fault.

    Biology trumps

    Dr. Mark George trained in psychiatry and neurology. He doesn't see a distinction between the two.
    Both deal with disorders caused by dysfunctional brain circuitry. So why are neurological disorders — Parkinson's disease, for instance — viewed without the stigma that clouds others like depression and bipolar disorder?
    “Stigma is really hard for me to deal with. I've trained across these disciplines, and to me it's all the same,” said George, director of MUSC's Center for Advanced Imaging Research and its Brain Stimulation Laboratory.
    Stigma stems from historical misunderstandings, such as when people thought the mentally ill were inherently weak-minded or evil, or when George's medical school professors taught that the brain was a fixed organ, incapable of changing and repairing itself.
    Not true.
    Modern imaging technology is allowing researchers to track the brain's activity and to examine its wiring, structures and tissue micro-architecture to see exactly what is going on inside a living, thinking organ.
    It has revolutionized knowledge of psychiatric disorders.
    “The brain is really the last frontier in medicine,” George said.
    What is now clear to researchers is that malfunctioning brain circuitry, and its interplay with genetics, trauma and environmental stress, plays a major role in many illnesses, including depression, anxiety and addictions. A new mantra rising among medical professionals calls mental illnesses “brain disorders.”
    “We have these powerful imaging tools so we can see all of these things,” George said. “This new understanding should make people wake up to stigma.”
    For instance, when imaging showed differences in the brains of people with attention deficit hyperactivity disorder, it indicated that the problem wasn't bad parenting or a lack of discipline. It was based in physiology.
    “That was huge. Imaging can add that legitimacy,” said Joseph A. Helpern, professor and vice chairman for research in radiology and endowed chair in brain imaging at MUSC.
    Today, MUSC psychiatry is the largest research department in its College of Medicine, and is especially known for research of addictions and imaging techniques. And just this month President Barack Obama announced his BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative to map the brain's activity in unprecedented detail.
    So much research promises better understanding of this final frontier, and new treatments for when its circuits malfunction.
    “In mental illness and addiction, the brain is different,” said Rhonda Faughender, clinical director for adult services at Palmetto Behavioral Health System. “But we can retrain our brains.”
    Which means there is hope for people like Baker.

    Biology of change

    Baker sits in a small room in the Institute of Psychiatry lying on what resembles a dentist's chair.
    Dr. Baron Short, clinical director of MUSC's Brain Stimulation Services, positions a plastic block containing an electromagnetic coil onto the upper left area of Baker's forehead. She wears neon yellow earplugs to block out the rapid and fairly loud tapping of electrical pulses that penetrate her scalp and skull.
    Brain tissue lacks pain receptors, so she can't feel where the pulses penetrate into her prefrontal cortex, the upper front area of the brain.
    Coils pulse for four seconds, then quiet for 20. The sensation on her skin is irritating but not painful, Baker said, like getting snapped by a rubber band.
    Transcranial Magnetic Stimulation, recently approved by the FDA for the treatment of depression, aims to rouse the prefrontal cortex. It is considered the brain's CEO, responsible for abstract thinking and regulating behavior and emotions, and it tends to be underactive in people with depression.
    This underactivity, in turn, appears to affect the brain's limbic system, a primitive area often called the “feeling and reacting brain” that is important in memory formation. This area tends to be overly active in people with depression.
    “We're helping the brain re-regulate itself,” Short explained.
    Brain stimulation may hold promise in treating other illnesses, including addiction, which imaging indicates is another form of brain disorder. This also could change societal views of addiction — after all, when it comes to stigma, few disorders carry more shame than drug addiction, George said.
    Yet it appears that some people are predisposed to addiction due to overly active brain regions that control craving and desire, while impulse-control areas are not as active. Researchers are testing ways to correct this circuitry just as they are with depression and other illnesses.
    On Monday, George and a team of researchers will publish a study in the journal Biological Psychiatry that showed high-frequency TMS significantly reduced nicotine craving even in heavy smokers.
    “People still think it's about bad behavior and not an illness,” George said. “But it's not you. It is a part of the brain that needs to exercise differently.”

    Surviving stigma

    Today, when someone is released from a psychiatric hospital, there are no sympathy cards in the mail, no meals provided by friends, no flowers or well-wishers eager to visit.
    Often, there is only the suffocating silence of fear and rejection.
    “We as a people don't look at mental illness as an illness. If we just pull up our bootstraps and go, we can go. And it's so untrue. It's an illness just like heart disease or cancer,” said Wanda Brockmeyer, emergency services director for Roper St. Francis Healthcare.
    When Baker turned 50 recently, she cried.
    “This isn't where I wanted to be,” she said. Then she reminded herself: I'm not a loser.
    She wonders if others see her that way.
    “Imagine if you said to a person, 'If you had only been stronger, you wouldn't have gotten cancer,'” Baker said.
    She agreed to share her story here to challenge the stigma, to remind people that those with mental illness are parents, children, neighbors. And that their illnesses aren't their fault.

    Reach Jennifer Hawes at 937-5563, follow her on Twitter at @JenBerryHawes or subscribe to her at

    Friday, April 12, 2013

    Altering brain activity with magnetic fields may relieve chronic pain

    Altering brain activity with magnetic fields may relieve chronic pain

    Treating the brain with magnets went mainstream a few years ago, when the technique proved successful at relieving major depression. Now the procedure, repetitive transcranial magnetic stimulation (rTMS), shows promise for another mysterious, hard-to-treat disorder: chronic pain.
    Until now, pain seemed out of reach for rTMS because the regions involved in pain perception lie very deep within the brain. The other disorders helped by rTMS all involve brain areas close to the skull. To treat depression, for example, a single magnetic coil directs a magnetic field at the dorsolateral prefrontal cortex, a region of the brain's outer folds. When aimed at different areas of these outer folds, rTMS improves the motor symptoms of Parkinson's disease, staves off the damage of stroke, lessens the discomfort that follows nerve injury and treats obsessive-compulsive disorder. The magnetic field affects the electrical signaling used by neurons to communicate, but how exactly it improves symptoms is unclear—scientists suspect rTMS may redirect the activity of select cells or even entire brain circuits.

    To extend the technique's reach, David Yeomans, a neuroscientist at Stanford University, and his colleagues used four magnets rather than one and employed high-level math to steer the resulting complex fields. Their target was an area called the anterior cingulate cortex (ACC), an area active in the experience of all types of pain, regardless of its source or nature.

    The researchers aimed the magnetic impulses at the ACC of healthy volunteers for 30 minutes. Immediately afterward, subjects underwent a PET scan of brain activity. During the scan, subjects reported minute-by-minute pain sensations from a hot plate applied to their arm. After rTMS, subjects rated their pain nearly 80 percent lower than they had before treatment, and the PET scan revealed blunted activity in the ACC.

    Next the researchers tested the treatment on chronic pain in people with fibromyalgia, a mysterious pain syndrome that causes pain and tenderness all over the body. Patients received a daily dose from the magnets for four weeks and saw a reduction in their daily pain by almost half, which lasted for four weeks beyond treatment.

    The study, presented at last October's meeting of the Society for Neuroscience in New Orleans, shows the potential of rTMS for many kinds of pain. The procedure has become increasingly common and available since 2008, when the Food and Drug Administration approved it for treating major depression. “More psychiatrists are bringing it into their armamentarium,” Yeomans says. Now that it appears this noninvasive technique “can affect pain without putting new molecules into your body,” he adds, relief may be close for people for whom drug therapies have failed or simply do not exist.

    $300 - Cost of a typical transcranial magnetic stimulation (TMS) session. TMS therapies often include 20 to 30 sessions, at a total cost of between $6,000 and $10,000.

    12/08 - Date the FDA approved TMS in the U.S. to treatmajor depression in adults who had failed to improve on an antidepressant regimen. Canada had granted the same approval six years earlier.

    1 - Number of conditions TMS is approved to treat: major depressive disorder. Research suggests the technique can also help people with post-traumatic stress disorder, bipolar disorder and Parkinson's disease, among other ailments.

    387 - Number of recent clinical trials testing TMS for a variety of conditions, including schizophrenia, anorexia, Alzheimer's disease, autism and cerebral palsy.

    1985 - Year TMS was first developed and tested. Anthony T. Barker of Royal Hallamshire Hospital in Sheffield, England, used the machine to noninvasively stimulate the cerebral cortex.

    Friday, April 5, 2013

    Cyberonics Provides Update On Submission To CMS


    Published: April 4, 2013 

    Cyberonics, Inc. By Cyberonics, Inc.

    HOUSTON, April 4, 2013 — /PRNewswire/ -- Cyberonics, Inc. (NASDAQ:CYBX) today provided an update on its recent submission to the Centers for Medicare & Medicaid Services ("CMS") seeking reimbursement coverage for the treatment-resistant depression ("TRD") indication for the VNS Therapy® System.

    As previously announced, the company submitted a request to CMS for reconsideration of coverage for VNS Therapy for TRD and expected to receive a formal acknowledgment from CMS accepting or rejecting its request by the end of March 2013. To date, the company has not received a formal response from CMS, but is engaged in an ongoing dialogue regarding the reconsideration request. At this time, the timing and ultimate outcome of the dialogue is uncertain.

    "We believe the total body of evidence that began appearing in the scientific literature in 2000 presents compelling rationale for access to VNS Therapy in a very ill subpopulation of Medicare beneficiaries," said Dan Moore, Cyberonics' President and Chief Executive Officer. "We look forward to continuing our discussion with CMS with the objective of securing this access, although there can be no assurance that the coverage objectives will be met."