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Saturday, March 31, 2012

Important Treatment Option for Depression Receives Medicare Coverage

Important Treatment Option for Depression Receives Medicare Coverage

3/30/12 11:16 AM
Providence, R.I. - Transcranial Magnetic Stimulation (TMS), an FDA approved treatment for depression that Butler Hospital began offering in 2008, is now covered by Medicare. Thanks to the work of advocates like Dr. Linda Carpenter, Butler’s Chief of Mood Disorders and the Neuromodulation, patients in New England with Medicare coverage are able to receive this innovative, effective treatment for acute depression.

Butler was one of the first hospitals in the region to offer TMS therapy three years ago. At the time, Dr. Carpenter was excited for the hope this treatment could bring to patients unable to find symptom relief through medication. What Dr. Carpenter didn’t anticipate was that in addition to providing treatment and care for her patients using TMS, she’d also spend months advocating on their behalf, writing countless appeals letters to insurance companies who were reluctant to pay for the treatment, and representing the patients in legal and community hearings to make the case for coverage of the new treatment.

“The initial FDA approval of TMS therapy gave hope to many psychiatrists who saw patients whose symptoms were not relieved through traditional medications,” states Dr. Carpenter, adding that it wasn’t until she began treating patients with TMS that she realized how difficult an obstacle she and her patients would face trying to convincing insurers that this was the best and only line of treatment that could relieve their symptoms.

Treatment with TMS is reserved for patients whose depression does not improve with antidepressant medication therapy. Unlike more invasive options after medication, like vagus nerve stimulation (VNS) which requires surgery, and electroconvulsive therapy (ECT) which requires anesthesia, TMS uses a noninvasive device that beams magnetic pulses through the skull of an awake patient, to stimulate the brain and induce electrical activity in circuits throughout the brain involved in major depression. During TMS Therapy, patients sit in a chair that resembles something one might find at a dentist office. An MRI-strength magnet is positioned near the patient’s scalp on the left side, aimed at the prefrontal cortex. The treatment sessions each take about 30 minutes and are recommended five times a week for up to six weeks.

“TMS is a game changer for the treatment of depression. And now that Medicare has approved coverage of TMS for the patients who need it, we’re hopeful that other insurers will follow,” said Dr. Carpenter. “Since it was approved by FDA in 2008, ongoing research has consistently shown the benefits of TMS for patients with depression. Medicare’s decision to cover the treatment really reflects how strong the science is, which will in turn help many clinicians and patients realize that TMS is safe and effective.”

Butler Hospital is the only private, nonprofit psychiatric and substance abuse hospital serving adults, adolescents and children in Rhode Island and southeastern New England. Founded in 1844, it was the first hospital in Rhode Island and has earned a reputation as the leading provider of innovative psychiatric treatments in the region. The flagship hospital for the Department of Psychiatry and Human Behavior at the Alpert Medical School of Brown University, Butler is recognized worldwide as a pioneer in conducting cutting-edge research.,66462

3 comments on this story|Add your comment
Herbert wrote:
This article is seriously misleading in my opinion especially the following quotation:

"And now that Medicare has approved coverage of TMS for the patients who need it, we’re hopeful that other insurers will follow,”

I strongly feel Dr. Carpenter was probably misquoted and made no such statement. While maybe there have been instances of Medicare approving coverage on a case by case basis, upon additional investigation and several conversations, I've learned there is no formal CMS (Centers for Medicare/Medicaid Services) approval for this therapy option.

Had there been such an approval I'm certain the sponsor of the therapy would be all over the media promoting its formal approval.

I am an advocate for additional treatment options knowing that many of the conventional therapies have proven ineffective for this unique population of patients.


Yesterday at 4:10 AM

Severon wrote:
Herb, not hard to determine the motive for your blatant lies given your user name vns therapy (vagal nerve stimulation therapy- the surgical implantation of a electronic stimulator, a now defunct treatment not longer covered by insurance companies or Medicare for depression)

TMS DOES HAVE MEDICARE COVERAGE IN NEW ENGLAND, please click below to read the press release from the company that makes the policy decisions for Medicare in New England, and the company, NHIC's own update to announce the coverage:

You are an advocate of your treatment, which requires a surgical procedure, and has been proven inneffective for depression.
You are either very ill-informed, malicious, or jealous. After posting your retraction, please do not speak for Medicare or their local coverage determinations, unless your intention is to mislead, which of course you seem very effective at when unchecked by the truth.

7 hours ago

Herbert wrote:
Hi Severon,

First, I say thank you for the informational links you’ve listed.

Secondly, I live and learn every day and most often from those who would politely take the time to share with me. As for my motives and any other personal assessment you may have of me, you’re grossly off base.

What is truly fascinating to me is the fact that there has been no national determination by CMS to the best of my knowledge as was the case with VNS Therapy for Depression. Those many years ago, being a total novice, I thought once the FDA approved a treatment that was it. Go know, I believe for the first time, a medical device treatment was FDA approved but CMS – National declined reimbursement and the rest is history along with a number of other issues.

Now, I learn from you by way of citing those two links that it appears each and every state or district can make their own Medicare determination. Again, thank you. I was not aware of that fact.

I am an advocate for patient education while encouraging hope and persistence. I also advocate for research into newer treatment options because the conventional therapies have proven ineffective for this seriously ill large population of patients. As a very, very long-time support person and health care advocate for my spouse I personally am happy to read about this decision as TMS would be an option I would consider before for ECT or VNS for a number of reasons.

I do not endorse or promote the use of any treatments, products and/or companies contrary to any of your beliefs.

Now I would like to see if in fact Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont actually follow through on this decision and if the private insurance carriers follow suit?

Since you are familiar with the situation and you do have my email address I’d appreciate your taking time, if you don't mind, to try to keep me updated as events unfold. I shall share this information with a number of others who do have interest in this and other alternative treatment options.

Thanks again, your reply was most appreciated.


12 minutes ago

Local Coverage Decision from Medicare Administrative Contractor Cites CEPAC in Coverage Policy  

-- Draft non-coverage policy changed, noting the role played by an adapted comparative effectiveness report from the Agency for Healthcare Quality and Research and the New England Council public votes --

Boston, Mass., January 30, 2012 –The Medicare Administrative Contractor for most of New England, NHIC, Corp, has issued a final local coverage decision granting first-in-the-nation Medicare coverage for repetitive transcranial magnetic stimulation (rTMS) for patients with treatment-resistant depression. The new coverage policy, which takes effect in March, reverses a non-coverage draft policy posted in November 2011, and represents the first positive local Medicare coverage policy for rTMS in the nation. In describing the factors considered for this policy change, the Medicare Contractor cited numerous comments and statements received from patients and clinicians, several of which cited the comparative effective review produced by the federal Agency for Healthcare Research and Quality (AHRQ), supplementary analyses of this report prepared for the New England Comparative Effectiveness Public Advisory Council (CEPAC), and the votes taken by the CEPAC as part of its public deliberation on the evidence.

CEPAC convened in Providence, Rhode Island in December 2011 to consider the evidence on the comparative clinical effectiveness and comparative value of a variety of nonpharmacologic interventions for patients with treatment-resistant depression. CEPAC is the central component of a project funded by AHRQ and directed by staff from the Institute for Clinical and Economic Review (ICER), a leading academic comparative effectiveness research group based at the Massachusetts General Hospital’s Institute for Technology Assessment in Boston.
“Our goal in creating CEPAC was to improve the application of good evidence to policy decisions by regional health insurers, and to encourage the use of evidence by clinicians and patients as well,” stated Steven D. Pearson, MD, MSc, President of ICER. “We are gratified that the AHRQ report, our supplemental analyses, and CEPAC’s deliberation and voting were all noted by stakeholders engaged in the coverage process, and ultimately cited by the Medicare Contractor as influential elements in his final coverage decision for the use of rTMS in treatment-resistant depression. Having an independent group of physicians and public representatives deliberate on these issues and render specific judgments about the evidence is an important step in reaping the benefits of comparative effectiveness research.”

The full coverage policy from the Medicare Administrative Contractor is available online. NHIC, Corp is the Medicare Administrative Contractor for Jurisdiction 14, which covers Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont, serving 1.3 million Medicare beneficiaries and more than 53,000 healthcare providers.

At its December 2011 meeting, CEPAC voted 10 to 5 that the evidence was adequate to demonstrate that for patients with treatment-resistant depression rTMS was as good, or better, than usual care (i.e. general supportive psychotherapy with or without continued use of antidepressant medication). CEPAC also voted 9 to 6 that the evidence was adequate to demonstrate equivalent or superior outcomes for rTMS compared to electroconvulsive therapy (ECT). CEPAC then reviewed evidence on the cost-effectiveness and potential budget impact of rTMS and the majority voted that, at current Medicare reimbursement rates, the use of TMS represents “reasonable value” when compared to usual care and a “low value” when compared to ECT. The final CEPAC meeting report includes supplementary analyses to augment the AHRQ review of nonpharmacologic interventions for treatment-resistant depression in adults. The report also reviews the results of all the votes taken by CEPAC on the adequacy of evidence to demonstrate the comparative clinical effectiveness and value of different approaches to treatment-resistant depression.

CEPAC is a regional body whose goal is to provide objective, independent guidance on the application of medical evidence to clinical practice and payer policy decisions across New England. Supported by a federal grant from the Agency for Healthcare Research and Quality (AHRQ), and with backing from a consortium of New England state health policy leaders, CEPAC holds public meetings to consider evidence reviews of medical tests and treatments and provide judgments regarding how the evidence can best be used across New England to improve the quality and value of health care services. CEPAC consists of practicing physicians with experience in evaluating and using evidence in the practice of healthcare, as well as patient/public members with experience in health policy, patient advocacy and public health.

ICER is managing the day-to-day operations of CEPAC as part of its federally funded RAPiD (Regional Adaptation for Payer Policy Decisions) initiative meant to develop and test new ways to adapt federal evidence reviews to improve their usefulness for patients, clinicians, and payers. Nominations are currently open for new members of CEPAC. A list of CEPAC members, information on nominations and other information about the project, is available online at

About ICER
The Institute for Clinical and Economic Review (ICER), based at the Massachusetts General Hospital’s Institute for Technology Assessment (ITA) and an affiliate of Harvard Medical School, provides independent evaluation of the clinical effectiveness and comparative value of new and emerging technologies. Structured as a fully transparent organization, ICER seeks to achieve its ultimate mission of informing public policy and spurring innovation in the use of evidence to improve the value of health care for all. For more information, please visit

Friday, March 30, 2012

Depression linked with sleep breathing problems, study finds

Depression linked with sleep breathing problems, study finds

  • Myth #4: Naps are disruptive to your sleep schedule
Experiencing breathing problems during sleep may raise your risk of depression, a new study suggests.

Women with sleep apnea, in which breathing becomes shallow or pauses briefly during sleep, were 5.2 times as likely to have depression compared with women without the condition. Men with sleep apnea were 2.4 times as likely to have depression as men without the condition, according to the study from researchers at the Centers for Disease Control and Prevention (CDC).

Participants in the study who had other breathing problems during sleep also had an increased risk of depression. However, the researchers found no increased likelihood of depression among people who snore.

"Snorting, gasping or stopping breathing while asleep was associated with nearly all depression symptoms, including feeling hopeless and feeling like a failure," said study researcher Anne Wheaton, an epidemiologist with the CDC. "We expected persons with sleep-disordered breathing to report trouble sleeping or sleeping too much, or feeling tired and having little energy, but not the other symptoms."

Both depression and breathing problems during sleep are common, and both are underdiagnosed, the researchers wrote. Screening people who have for one disorder for the other could lead to better diagnosis and treatments, they said.

The researchers took into account other factors that might influence the results, such as age, sex and weight. The results are in line with those of the other studies, the researchers said.

The study found an association, not a cause-and-effect link. However, the researchers wrote that evidence from other research suggests that breathing problems during sleep may contribute to the development of depression. For example, one previous study found a link between the severity of breathing problems during sleep and the odds of later developing depression. And other studies have shown that people who received treatment for sleep apnea showed improvement in their depression.
"Mental health professionals often ask about certain sleep problems, such as unrefreshing sleep and insomnia, but likely do not realize that [breathing problems during sleep] may have an impact on their patients' mental health," the researchers wrote in their conclusion.

Although exactly how the link might work is unclear, it could partly be explained by the fact that people with breathing problems experience sleep that is fragmented, or may have low levels of oxygen in the blood during sleep.

The researchers used data collected from 9,714 adults who participated in the National Health and Nutrition Examination Survey, which is an ongoing study conducted by the CDC.

Participants were considered to have depression based on their answers to a questionnaire asking about how often they experienced symptoms of depression.

Six percent of men and 3 percent of women in the study reported having physician-diagnosed sleep apnea.

The study was limited in that participants' depression and sleep problems were measured at only one point in time, and in that it relied on self-reported symptoms. People may not be aware they have breathing problems during sleep, and there was no information about whether participants were being treated for depression.

The study is published in the April issue of the journal Sleep.

Read more:

Tuesday, March 20, 2012

Deep brain stimulation studied for depression, other disorders

Published: Wednesday, March 21, 2012, 12:02 AM
Body and Mind staff
People who struggle with depression know the frustration of that familiar descent into darkness that comes when medications fail — will nothing restore hope?
What if treatment were available that would work directly on the neurons in the brain, in effect jamming their circuits to relieve debilitating symptoms of depression?

One option might be deep brain stimulation.

“It’s just in the experimental stages, but right now, it has a lot of promise,” said Dr. Stephen Powers, referring to the use of DBS as a treatment for depression.

Used to treat movement disorders since the late 1990s, deep brain stimulation involves implanting electrodes into the brain through which electrical impulses are sent to block or modify the firing of the neurons that cause the problems. The amount of stimulation is externally controlled by a pulse generator, a pacemaker-like device placed under the patient’s skin in the upper chest.

Powers, now president of the Pennsylvania Neurosurgery and Neuroscience Institute Inc. in Lower Paxton Twp., was among the first neurosurgeons in Pennsylvania to use deep brain stimulation when he worked at Penn State Milton S. Hershey Medical Center in 1997. It is currently approved for use on Parkinson’s disease, uncontrollable movements called benign essential tremors and primary dystonia, a birth defect where a person has uncontrollable twisting of a body part.

For Parkinson’s patients, it has transformed lives by giving them tremor control and other relief from symptoms. “It works dramatically well, like throwing a switch,” said Dr. James McInerney, a neurosurgeon who specializes in deep brain stimulation at Hershey Medical Center.

These positive results have researchers eyeing the procedure for depression, epilepsy, stroke and more, although its use for the other disorders is in experimental stages only.

“The potential for DBS is close to unlimited,” McInerney said.

Psychiatric applications of deep brain stimulation show great promise, doctors said. It is already approved by the Food and Drug Administration for use in obsessive compulsive disorder on a “humanitarian device exemption” meaning it may only be done at certain institutions that establish a review board to supervise clinical testing.

Though there have been a handful of published studies in the last seven years on its use for depression, the number of patients involved is small, so there is still much research to be done, Powers said.

He said the research looked at two areas of the brain that are associated with behavior. “The studies found that DBS is safe and some patients got significantly better and could return to work,” Powers said. However, there is a caveat: Some patients entered an abnormal mental state known as hypomania and two committed suicide.

“There is still work to be done. The real concern is that by affecting an individual’s behavior like this, you may be somehow doing mind control,” said Powers, who noted that deep brain stimulation got its start in the early 1970s when it was first used to treat pain disorders. The societal atmosphere of the early ‘70s led to fears of government intrusion into individual’s lives and so DBS was dropped for about 20 years, he said.

Unlike the lobotomy, an irreversible procedure that interrupted abnormal pathways in the brain by cutting the connection, DBS is not destructive and can be undone simply by stopping its use, McInerney said. “It’s actually a restorative procedure and it’s done on a much more targeted area of the brain,” he said.

Though FDA approval is expected, McInerney said the FDA admits difficulty in assessing DBS for depression because it is hard to qualify its application for “quality of life” vs. concrete usage for something like tremor control in Parkinson’s disease.

“Many people in this country are on anti-depressants and most would not be a candidate for DBS,” McInerney said. “This would be for people being hospitalized for depression — the extreme sufferers who are at high risk for suicide.”

Aside from depression, DBS is expected to win FDA approval for use in epilepsy, doctors said. For epilepsy, a special response neuro stimulator with closed loop programming allows for information exchange between the brain and the programming unit to control the needed stimulation signal, Powers said. It has shown a 50 percent reduction in seizures, he said.
Deep brain stimulation also shows promise for another problem that is fast becoming a national health crisis — obesity.

“We’re not sure how it works. It may speed up the metabolism by stimulating different parts of the brain or work on the reward center,” McInerney said.

Use of DBS on brain injury from stroke is hard to qualify because everyone’s injury can be so different, but doctors say research is ongoing.

“It has been tried for severe head injuries where people are in a vegetative or minimally responsive state and they have become more interactive. While it has not brought them back to normal, it has improved their rehabilitative outlook,” McInerney said.

The cost effectiveness of deep brain stimulation for all these things has yet to be proven, doctors said.

For example, the standard DBS treatment for Parkinson’s requires $40,000 in hardware and $14,000 in a battery pack that must be replaced every three years over the patient’s lifetime, so it is an expensive treatment, Powers said.

If approved for depression use, the key would be in narrowing criteria for use or else insurance companies would likely not cover it, McInerney said.

However, he added, “for those extreme sufferers, it might be cheaper than ongoing hospitalizations over an indefinite number of years.”

Written by CAROLYN KIMMEL For The Patriot-News

Study shows how electrotherapy may treat depression

Study shows how electrotherapy may treat depression

  • 694940094001_1409784734001_640-brain.jpg
Scientists have discovered how electroconvulsive or electric shock therapy - a controversial but effective treatment - acts on the brains of severely depressed people and say the finding could help improve diagnosis and treatment of mental illness.

Electroconvulsive therapy (ECT) involves first anaesthetizing the patient and then electrically inducing a seizure.

It has a controversial reputation - gained in part because of its role in the 1975 film "One Flew Over The Cuckoo's Nest" starring Jack Nicholson - but is a potent and effective treatment for patients with mood disorders like severe depression.

Yet despite it being used successfully in clinical practice around the world for more than 70 years, scientists have until now not been entirely clear how or why it works.

Now a team from Aberdeen University in Scotland has shown for the first time that ECT affects the way different parts of the brain involved in depression communicate with each other.

In a study published in the Proceedings of the National Academy of Sciences (PNAS) journal they found ECT appears to turn down overactive connections between parts of the brain that control mood and parts that control thinking and concentrating.

This stops the overwhelming impact that depression has on patients' ability to enjoy life and carry out day-to-day activities, they said.

"We've solved a 70-year-old therapeutic riddle," said Ian Reid, a professor of psychiatry at the University of Aberdeen who led the study.

"Our key finding is that if you compare the connections in the brain before and after ECT, ECT reduces the connection strength," he said in a statement.

"For the first time we can point to something that ECT does in the brain that makes sense in the context of what we think is wrong in people who are depressed."

In recent years, experts have developed a new theory on how depression affects the brain that suggests there is a "hyperconnection" between the areas of the brain involved in emotional processing and mood change and the parts of the brain involved in thinking and concentrating.
David Nutt, a professor of neuropsychopharmacology at Imperial College London who was not involved in the ECT study, said its findings "make a lot of sense.

"The disabling of connections between different areas of the brain is what I would have predicted from the depression literature," he said in an emailed comment.

He said the results also chime with a study Nutt published in January which found that psilocybin, the active ingredient in the psychedelic drug known as magic mushrooms, also disrupts this network of connections and may also be effective in treating severe depression.

The electrotherapy study involved using functional magnetic resonance imaging (fMRI) to scan the brains of nine severely depressed patients before and after ECT and then applying complex mathematical analysis to investigate brain connectivity.

Aberdeen University's chair of neuroimaging Christian Schwarzbauer, who devised the new method for analyzing the connectivity data, said it enabled the team to see to what extent more than 25,000 different brain areas communicated with each other.

He said the new method could also be applied to a wide range of other brain disorders such as schizophrenia, autism, or dementia, and "may lead to a better understanding of the underlying disease mechanisms and the development of new diagnostic tools."

The researchers said they now hope to continue monitoring the patients to see if the depression and hyperconnectivity returns. They also want to compare their ECT findings with the effects of other therapies used to treat depression such as psychotherapy and anti-depressants.

Read more:

Proven Non-Drug Treatment for Major Depression Now Available

Proven Non-Drug Treatment for Major Depression Now Available

Posted Monday March 19, 2012– 11:50am
Depression has long been a battle for many, and for those who continue to suffer even with medication, there is finally an option that is restoring the lives of thousands.
Transcranial Magnetic Stimulation (TMS), approved by the FDA in October 2008 and recently featured on the Dr. Oz Show, is a major technological breakthrough in psychiatric treatment. This cutting edge technology for depression is now available at Southern California TMS Centers in Beverly Hills and Pasadena, CA.
TMS can relieve depression when antidepressants are ineffective or cause intolerable side effects. This non-drug treatment is ideal for patients such as pregnant or nursing women, or those who want to avoid medication altogether due to side effects such as weight gain or sexual dysfunction.
TMS stimulates an area of the brain known to be underactive in patients with depression. An MRI strength magnet is positioned over the head to deliver repetitive magnetic pulses. Mood pathways are stimulated and become more active, restoring normal brain function and improving depressive symptoms.
TMS treatments are highly effective, safe, and well tolerated. No anesthesia or sedation is required, so patients are able to drive to and from treatment and continue their everyday activities.
In addition to depression, TMS is also used for other psychiatric and neurologic conditions such as Bipolar Disorder, chronic pain, Fibromyalgia, anxiety, migraines, and auditory hallucinations. Research is also being done using TMS for post-stroke recovery.
Dr. Eric Levander, a Beverly Hills psychiatrist trained in TMS has said, “A majority of my depressed patients who have failed to get much relief using different antidepressant medication combinations have gotten considerably better with TMS.“
SoCal TMS Center is the largest provider of TMS in the country with multiple locations and 9 affiliated doctors. 80% of their patients have experienced improvement, with profound recovery in over half.
There is now an alternative for those suffering from depression. Southern California TMS Center has the experience and compassion to help you overcome your depression.
For information contact Southern California TMS Center (866) 322-7776,
By: Todd Hutton, MD

Low Field Magnetic Stimulation (LFMS) in Mood Disorders: 6 Treatments (LFMS6tx)

Low Field Magnetic Stimulation (LFMS) in Mood Disorders: 6 Treatments (LFMS6tx)
This study is currently recruiting participants.
Verified March 2012 by Mclean Hospital

First Received on March 14, 2012. Last Updated on March 15, 2012 History of Changes
Sponsor: Mclean Hospital
Information provided by (Responsible Party): Michael Rohan, Mclean Hospital Identifier: NCT01557192
To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation (LFMS) as an antidepressant treatment in subjects with mood disorders.

Bipolar Depression
Unipolar Depression
Device: Low Field Magnetic Stimulation Device Phase I

Study Type: Interventional
Study Design:Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title:Low Field Magnetic Stimulation in Mood Disorders in Six Visits

Resource links provided by NLM:

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Change in Montgomery-Asberg Depression Rating Scale (MADRS)score [ Time Frame: at baseline and at week 3 ] [ Designated as safety issue: No ]
    MADRS scores will be compared between the baseline and week 3, one week after the final treatment.
  • Change in Positive-Negative Affect Scale (PANAS)score [ Time Frame: at baseline and at one and at week 3 ] [ Designated as safety issue: No ]
    PANAS scores will be compared between the baseline and week 3, one week after the final treatment.

Secondary Outcome Measures:
  • Immediate mood improvement as measured by the difference in post and pre treatment PANAS ratings [ Time Frame: at baseline and immediately before and after each treatment, 6 treatments across 2 weeks ] [ Designated as safety issue: No ]
    PANAS scores will be assessed at baseline and before and after each treatment. There are six treatments (Monday, Wednesday and Friday for two weeks).
  • Change in Montgomery-Asberg Depression Rating Scale (MADRS)score [ Time Frame: at baseline and at week 4 ] [ Designated as safety issue: No ]
    MADRS scores will be compared between the baseline and week 4, two weeks after the final treatment.
  • Change in Positive-Negative Affect Scale (PANAS)score. [ Time Frame: at baseline and at one and at week 4 ] [ Designated as safety issue: No ]
    PANAS scores will be compared between the baseline and week 4, two weeks after the final treatment.

Estimated Enrollment:200
Study Start Date:May 2010
Estimated Study Completion Date:May 2015
Estimated Primary Completion Date:May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active LFMS treatment
20 minute exposure to the LFMS electromagnetic field treatment
Device: Low Field Magnetic Stimulation Device
The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. Subjects will be given one 20 minute exposure to either the LFMS or sham electromagnetic field treatment.
Other Name: LFMS
Placebo Comparator: Sham LFMS treatment
20 minute exposure to either the sham (inactive) electromagnetic field treatment
Device: Low Field Magnetic Stimulation Device
The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. Subjects will be given one 20 minute exposure to either the LFMS or sham electromagnetic field treatment.
Other Name: LFMS

Detailed Description:
The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. The field and timing parameters of the LFMS pulses, such as pulse timing, duration, frequency, and electric and magnetic field distribution and direction are different from other neurostimulation methods.
The mechanism of action for the antidepressant effects of LFMS is hypothesized to be an effect on dendritic or synaptic activity in the cortex, brought about by low level electrical stimulation applied with particular timing. This is analogous to the synaptic effects of pharmaceutical antidepressants in providing a "boost" to synapses in certain brain regions.
Previous investigations of LFMS included depressed subjects with bipolar disorder. This study will evaluate the antidepressant effects of multiple LFMS treatments in bipolar disorder and major depressive disorder.

Ages Eligible for Study: 21 Years to 55 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. Subjects MUST be significantly depressed, currently.
  2. Subjects must not have serious physical illnesses, neurological diseases or dementias.
  3. Subjects will meet DSM-IV criteria for Bipolar Disorder Type I or II, Major Depressive Disorder, Post Traumatic Stress Disorder, or Obsessive Compulsive Disorder, and be currently depressed.
  4. Subject must have a Ham-D score > 17, YMRS score < 7 (bipolar subjects only), and a MADRS score > 18.
  5. Subjects must be capable of providing informed consent.
  6. Subjects must have an established residence and phone.
  7. Subjects may be medicated or unmedicated.
Exclusion Criteria:
  1. Dangerous or active suicidal ideation.
  2. Pregnant or planning on becoming pregnant.
  3. Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no major polysubstance abuse history, no history of dependence in last year, no drug use within last month).
  4. Mixed mood state or rapid cycling.
  5. Presence of a pacemaker, neurostimulator, or metal in head or neck.
Contacts and Locations
Please refer to this study by its identifier: NCT01557192

Contact: Rinah T Yamamoto,

United States, Massachusetts
McLean HospitalRecruiting
Belmont, Massachusetts, United States, 02478
Contact: Rinah T Yamamoto, Ph.D. 617-855-2862
Sponsors and Collaborators
Mclean Hospital
Principal Investigator:Michael L. Rohan, Ph.D.Mclean Hospital
More Information


Responsible Party:Michael Rohan, Imaging Physicist, Mclean Hospital Identifier:NCT01557192 History of Changes
Other Study ID Numbers:2010-P-001097
Study First Received:March 14, 2012
Last Updated:March 15, 2012
Health Authority:United States: Institutional Review Board

Keywords provided by Mclean Hospital:
Bipolar Depression
Electromagnetic Stimulation

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder
Mood Disorders
Affective Disorders, Psychotic
Mental Disorders
Behavioral Symptoms processed this record on March 18, 2012

Monday, March 19, 2012

Electroconvulsive Therapy For Depression - How It Works

Electroconvulsive Therapy For Depression - How It Works

Editor's Choice
Academic Journal
Main Category: Depression
Also Included In: Psychology / Psychiatry
Article Date: 19 Mar 2012 - 18:00 PDT

Electroconvulsive therapy (ECT) works by altering how different parts of the brain involved in depression communicate with each other, Scottish researchers reported in the journal PNAS (Proceeding of the National Academy of Sciences). ECT has been an effective and controversial therapy for depression for over seven decades; doctors knew it would often work, but were never sure why.

For individuals with serious mood disorder, using ECT, which involves anesthetizing them and using an electric shock to induce a seizure, has been the most effective treatment available for a long time.

A team of doctors and scientists from the University of Aberdeen and the University of Dundee, both in Scotland, have demonstrated that ECT impacts on how parts of the brain communicate - parts involved in depression.

When a patient has depression, parts of the brain that control mood and those involved in concentration and thinking have an overactive connection - ETC "turns down" that connection. When the connection goes back to normal, the patient can start enjoying life and performing daily tasks again.

The authors detected a close association between reduced connectivity after ECT and a considerable improvement in depressive symptoms.

Professor Ian Reid and team used fMRI (functional magnetic resonance imaging) to scan the brains of nine patients; six male and three female. All of them had been diagnosed with severe clinical depression and were successfully treated with ECT - two sessions per week, an average total of 8 treatments. None of the patients had responded to chemical antidepressants. They were scanned before ECT was applied, and then again afterwards. They used a new and complex mathematical analysis to measure any changes in brain connectivity.

Co-author, Professor Schwarzbauer said:

"With this new method we were able to find out to what extent more than 25,000 different brain areas 'communicated' with each other and how the brain's internal communication patterns differed before and after ECT treatment in severely depressed patients."

Professor Reid said:

"ECT is a controversial treatment, and one prominent criticism has been that it is not understood how it works and what it does to the brain. However we believe we've solved a 70 year old therapeutic riddle because our study reveals that ECT affects the way different parts of the brain involved in depression connect with one another.

For all the debate surrounding ECT, it is one of the most effective treatments not just in psychiatry but in the whole of medicine, because 75% to 85% of patients recover from the symptoms. Over the last couple of years there has been an emerging new perspective on how depression affects the brain.

This theory has suggested a 'hyperconnection' between the areas of the brain involved in emotional processing and mood change and the parts of the brain involved in thinking and concentrating. Our key finding is that if you compare the connections in the brain before and after ECT, ECT reduces the connection strength between these same areas - it reduces this hyperconnectivity.

For the first time we can point to something that ECT does in the brain that makes sense in the context of what we think is wrong in people who are depressed. "As far as we know no-one has extended that 'connectivity' idea about depression into an arena where you can show a treatment clearly treating depression, changing brain connectivity.

And the change that we see in the brain connections after ECT reflects the change that we see in the symptom profile of patients who generally see a big improvement."

The team members say they want to continue following-up on their patients to determine whether the hyperconnectivity, and the subsequent depression that comes of it, returns. They also plan to compare their ECT findings with those produced in studies that looked at other depression treatments, such as antidepressant medications and psychotherapy.

Professor Reid said:

"Although ECT is extremely effective, it is only used on people who need treatment quickly: either people who are very severely depressed, who are at risk from taking their own life and who perhaps can't look after themselves - or patients who have not responded to other treatments. The treatment can also affect memory, though for most patients this is short-lived. We monitor the memory function of all our patients receiving ECT in Grampian, and we find that function returns to normal within a few months.

Given the impact of depression itself on memory, it is perhaps unsurprising that such a rapidly acting treatment has this effect: certainly, the patterns of brain changes we have observed are consistent with this. However if we understand more about how ECT works, we will be in a better position to replace it with something less invasive and more acceptable. At the moment only about 40% of people with depression get better with treatment from their GP.

Our findings may lead to new drug targets which match the effectiveness of ECT without an impact on memory."

Professor Schwarzbauer said:

"The new method we devised for analysing the brain's functional connectivity in depression could be applied to a wide range of other brain disorders such as schizophrenia, autism, or dementia, and may lead to a better understanding of the underlying disease mechanisms and the development of new diagnostic tools."

Written by Christian Nordvist

Thursday, March 15, 2012

"The Dr. Oz Show" Introduces TMS, a New Treatment for Depression

SOURCE: West Coast TMS Institute

March 15, 2012 11:08 ET

"The Dr. Oz Show" Introduces TMS, a New Treatment for Depression

Dr. Kira Stein and The West Coast TMS Institute Offer Innovative TMS Treatment in Los Angeles

LOS ANGELES, CA--(Marketwire - Mar 15, 2012) - On March 14, 2012, nationally-known Dr. Mehmet Oz introduced the audience of "The Dr. Oz Show" to transcranial magnetic stimulation (TMS,) an innovative treatment for depression that is non-invasive and drug-free. Dr. Oz discussed TMS in an episode about exciting new treatments for chronic pain, depression and weight conditions. "I believe this could be an effective treatment," said Dr. Oz. "Why is every psychiatrist in the country not thinking about this for their patients?"

TMS is available in the Los Angeles area at The West Coast TMS Institute, founded and directed by psychiatrist Kira Stein, MD. Dr. Stein uses the NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy system, demonstrated on "The Dr. Oz Show," which offers state-of-the-art TMS treatment for depression. The U.S. Food and Drug Administration (FDA) approved NeuroStar® TMS in 2008 for the treatment of major depressive disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication.

Several medical societies, including the American Psychiatric Association and the Canadian Network for Mood and Anxiety Treatment have listed TMS therapy in their guidelines for the management of clinical depression that is unresponsive to other treatment.

"Depression, the most common mental disorder in the United States, is a debilitating disease that affects a rapidly-growing number of people. Unfortunately, many people do not achieve sufficient relief with antidepressant medications or suffer systemic side-effects from them" says Dr. Kira Stein. "Transcranial magnetic stimulation is a breakthrough technology that offers a safe, effective and proven alternative treatment to those who suffer from depression. Due to our individualized approach to TMS, about 80% of our patients respond positively, which is a better success rate than that of patients treated with medications alone."

TMS is available by medical prescription only and is delivered under the supervision of Dr. Stein. The outpatient procedure takes less than an hour and is typically administered in the institute's office for five days a week for four to six weeks. "We offer a calm, relaxing environment for patients, who can remain awake during the procedure, listening to the sound of the ocean or watching television," says Dr. Stein. "When the procedure is over, patients can drive and pursue normal daily activities."


Dr. Kira Stein is a board-certified psychiatrist with extensive experience in the treatment of psychiatric conditions using medication and non-medication approaches. Dr. Stein started the West Coast TMS Institute to help people who suffer from treatment-resistant depression or who cannot tolerate drug-related side effects. Dr. Stein is certified by Neuronetics in the clinical application of TMS therapy, and has completed intensive coursework on TMS at Harvard Medical School's Berenson-Allen Center for Noninvasive Brain Stimulation.

Dr. Stein graduated from the University of Rochester School of Medicine. She trained at the UCLA Neuropsychiatric Institute and was Chief Resident at the UCLA Anxiety Disorders Program from 2000-2001. Dr. Stein has been elected by her peers for inclusion in the Best Doctors in America® database from 2003 to 2012.

The West Coast TMS Institute offers TMS treatment in Los Angeles at its Sherman Oaks clinic. For more information, please call (818) 855-1694 or visit

Contact Information

Medtronic Receives Health Canada License for Deep Brain Stimulation Therapy in Refractory Epilepsy Patients

press release
March 15, 2012, 10:05 a.m. EDT

Medtronic Receives Health Canada License for Deep Brain Stimulation Therapy in Refractory Epilepsy Patients

Another Medtronic First in Neuromodulation in Canada

BRAMPTON, Ontario & MINNEAPOLIS, Mar 15, 2012 (BUSINESS WIRE) -- Medtronic, Inc. /quotes/zigman/233680/quotes/nls/mdt MDT +1.09% today announced that it has received from Health Canada a license for Medtronic Deep Brain Stimulation (DBS) Therapy for refractory epilepsy patients. Medtronic DBS therapy for refractory epilepsy delivers controlled electrical pulses to a location inside the brain which is involved in seizures.

The Health Canada license was based on data collected in Medtronic's clinical trial called SANTE(R) (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy). The SANTE trial was a prospective, randomized, double-blind pivotal study to evaluate the use of DBS therapy for patients with medically refractory epilepsy with partial-onset seizures. The trial collected data from 110 patients who were implanted with a Medtronic DBS system at 17 centers in the United States.

Medtronic DBS Therapy for refractory epilepsy is also approved in Europe. The therapy is not currently approved by the U.S. Food and Drug Administration for use in the United States for the treatment of refractory epilepsy.

To date, more than 85,000 patients worldwide have received Medtronic DBS therapy. The therapy is currently licensed in Canada and approved in other regions including the European Union and the United States, for the treatment of the disabling symptoms of essential tremor, advanced Parkinson's disease and dystonia, for which approval in the United States is under a Humanitarian Device Exemption (HDE)(1). The therapy is also approved for the treatment of severe, treatment-resistant obsessive-compulsive disorder not adequately controlled by medications in the European Union and in the United States under an HDE(2).

"Medtronic is a pioneer in the field of neuromodulation," said Lothar Krinke, Ph.D., vice president and general manager for the Deep Brain Stimulation business in Medtronic's Neuromodulation division. "We are proud of the expansion of indications to include epilepsy, which will allow more patients to benefit from our DBS therapy. This Medtronic First innovation provides a viable option for patients who are not responsive to other therapies. This follows closely the Canadian launch of the RestoreSensor(TM) neurostimulator for chronic pain, another Medtronic first. "

Medtronic's Leadership in Neuromodulation Medtronic developed and leads the field of neuromodulation, the targeted and regulated delivery of electrical pulses and pharmaceuticals to specific sites in the nervous system. The company's Neuromodulation business includes neurostimulation and implantable, targeted drug delivery systems for the management of chronic pain, common movement disorders, spasticity and urologic and gastrointestinal disorders.

Medtronic of Canada's innovative neuromodulation portfolio includes the following technologies:

-- RestoreSensor(TM) neurostimulator with AdaptiveStim(TM) technology: the world's first and only pain-management device designed to sense a change in the patient's body position or activity and automatically adjust stimulation to deliver the right amount of pain relief.

-- Activa(R) PC (Primary Cell), Activa(R) SC (Single Channel), and Activa(R) RC (Rechargeable Cell): The Activa line of neurostimulators includes the first rechargeable neurostimulator in Canada, with all three products featuring the most advanced multi-programming capabilities in Canada. Activa(R) PC is the neurostimulator licensed for use in refractory epilepsy. Only the ACTIVA family of neurostimulators provides clinicians with the ability to deliver stimulation in constant voltage or constant current mode, providing physicians with a choice based on their preference and clinical needs.

About Medtronic of Canada Ltd. Medtronic of Canada ( ) sells, services and distributes Medtronic products in Canada: medical devices used in cardiovascular medicine, diabetes, spinal and neurosurgery, and ear, nose and throat surgery. Medtronic of Canada employs over 745 Canadians, it is headquartered in Brampton, Ontario, has regional offices in Vancouver and Montreal and an atrial fibrillation (AF) ablation catheter manufacturing facility -- Medtronic CryoCath -- in the Montreal metropolitan area.

About Medtronic Medtronic, Inc. ( ), headquartered in Minneapolis, is the global leader in medical technology -- alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission.

(1) Humanitarian Device in the U.S.: The effectiveness of this device for the treatment of dystonia has not been demonstrated. (2) Humanitarian Device in the U.S.: The effectiveness of this device for the treatment of obsessive-compulsive disorder has not been demonstrated.

SOURCE: Medtronic, Inc.
        Medtronic, Inc. 
        Public Relations: 
        Melicent Lavers-Sailly, 905-460-3681 
        Donna Marquard, 763-526-6248 
        Investor Relations: 
        Jeff Warren, 763-505-2696

Tuesday, March 13, 2012

Vagus nerve stimulation ameliorated deficits in one-way active avoidance learning and stimulated hippocampal neurogenesis in bulbectomized rats.

Brain Stimul. 2012 Feb 24. [Epub ahead of print]

Vagus nerve stimulation ameliorated deficits in one-way active avoidance learning and stimulated hippocampal neurogenesis in bulbectomized rats.


O.-v.-Guericke University, Faculty of Medicine, Institute of Pharmacology and Toxicology, Leipziger Str. 44, D-39120 Magdeburg, Germany.



Vagus nerve stimulation (VNS) has been introduced as a therapeutic option for treatment-resistant depression. The neural and chemical mechanisms responsible for the effects of VNS are largely unclear.


Bilateral removal of the olfactory bulbs (OBX) is a validated animal model in depression research. We studied the effects of vagus nerve stimulation (VNS) on disturbed one-way active avoidance learning and neurogenesis in the hippocampal dentate gyrus of rats.


After a stimulation period of 3 weeks, OBX rats acquired the learning task as controls. In addition, the OBX-related decrease of neuronal differentiated BrdU positive cells in the dentate gyrus was prevented by VNS.


This suggests that chronic VNS and changes in hippocampal neurogenesis induced by VNS may also account for the amelioration of behavioral deficits in OBX rats. To the best of our knowledge, this is the first report on the restorative effects of VNS on behavioral function in an animal model of depression that can be compared with the effects of antidepressants.
Copyright © 2012 Elsevier Inc. All rights reserved.
[PubMed - as supplied by publisher]

Is there a role for vagus nerve stimulation therapy as a treatment of traumatic brain injury?

Br J Neurosurg. 2012 Mar 10. [Epub ahead of print]

Is there a role for vagus nerve stimulation therapy as a treatment of traumatic brain injury?


Department of Neurosurgery, Wessex Neurological Centre , Southampton.


This paper aims to review the current literature on vagus nerve stimulation (VNS) use in animal models of traumatic brain injury (TBI) and explore its potential role in treatment of human TBI. A MEDLINE search yielded four primary papers from the same group that demonstrated VNS mediated improvement following fluid percussion models of TBI in rats, seen as motor and cognitive improvements, reduction of cortical oedema and neuroprotective effects. The underlying mechanisms are elusive and authors attribute these to attenuation of post traumatic seizures, a noradrenergic mechanism and as yet undetermined mechanisms. Reviewing and elaborating on these ideas, we speculate other potential mechanisms including attenuation of peri-infarct depolarisations, attenuation of glutamate mediated excitotoxicity, stabilisation of intracranial pressure, enhancement of synaptic plasticity, upregulation of endogenous neurogenesis and anti-inflammatory effects may have a role. Although this data unequivocally shows that VNS improves outcome from TBI in animal models, it remains to be determined if these findings translate clinically. Further studies are warranted.
[PubMed - as supplied by publisher]

Sunday, March 11, 2012

Device helps Paradise woman deal with seizures

Device helps Paradise woman deal with seizures

By Trevor Warner
Assistant Managing Editor

Click photo to enlarge
Tina Lewis
An epileptic Paradise woman has found a way to control her seizures and she wants to get the word out.
After a snowmobile accident in Butte Meadows in 2002, Tina Lewis, 45, began suffering epileptic seizures - sometimes up to 20 uncontrolled seizures a day -- not to mention splitting headaches. She was taking numerous prescribed medications - at one point, 16 different pills four times a day. All the medications weren't to control her seizures, some were to counter the side effects of other medications.

Over the course of two years since the accident, her weight dropped to about 98 pounds and she was confined to a wheelchair. The several medications also affected her coherency and her speech. She said she spent a good two years in her bedroom because she was basically immobilized. Her eyesight was also affected. After a visit to her eye doctor, she was told her eyes weren't the problem, it was her medication.

Lewis finally took to the Internet to look for help.

"I was sick of being sick," she said.
That's when she came across Vagus Nerve Stimulation Therapy. Made by Cyberonics, Lewis describes it as a sort of "pacemaker for the brain."

"I spent days on the Internet researching," she said. "Research, research, research. I wanted to know everything about it."

She found out the VNS is not only FDA approved but is covered by most insurance plans. The VNS device was finally implanted on September 2006.

"Yeah, I was nervous, I was going to get my throat cut open," she said.

She was weaned off her medication and an electronic box was implanted near her left shoulder. A wire runs from the device, up her neck and into her brain.

"Seizures are about a misfire in your brain," she said.

From the box, electric pulses are sent to her brain to keep her stable. It was an outpatient process and she was finished with the operation and released within hours. Now when she begins to feel a seizure coming on, she runs a provided magnet over the box, which either stops or greatly reduces the severity of the seizure.

And it works, she said.

"Instead of 10 to 20 seizures a day uncontrolled with medication, I have two or three a month, with no medication and no wheelchair," she said.

Lewis always keeps her little black magnet with her in case she senses a seizure about to occur. She also keeps several black magnets stashed at various places around her house. And she never goes anywhere alone. There are side effects, she said. She goes hoarse when the box sends its electric pulse to the brain.

"You can feel it in your throat," she said.

There is also the sensation of minor electrocution, but she can live with it, she said.

"I'll take the side effects over the splitting headaches and the alternative," she said.

Now Lewis wants others to know about VNS therapy and she hopes her story will help stop the stigma of seizure disorders.

"Seizure disorders are hard to prove," she said.

She said a lot of people think seizures are drug and alcohol related fits, or a psychological disorder. Since the implant, her quality of life has shown clear improvement.

"I have more independence, no in-home care and no more meds," Lewis said. "I can think straight, I'm not cloudy like I was when I was on medication."

Friday, March 9, 2012

Pretreatment cerebral metabolic activity correlates with antidepressant efficacy of vagus nerve stimulation in treatment-resistant major depression: A potential marker for response?

J Affect Disord. 2012 Mar 5. [Epub ahead of print]

Pretreatment cerebral metabolic activity correlates with antidepressant efficacy of vagus nerve stimulation in treatment-resistant major depression: A potential marker for response?


Department of Psychiatry, Washington University, St. Louis, MO, USA; Department of Neurology and Psychiatry, Saint Louis University, St. Louis, MO, USA.



Pretreatment brain activity in major depressive disorder correlates with response to antidepressant therapies, including pharmacotherapies and transcranial magnetic stimulation. The purpose of this trial was to examine whether pretreatment regional metabolic activity in selected regions of interest (ROIs) predicts antidepressant response following 12months of vagus nerve stimulation (VNS) in 15 patients with treatment-resistant major depression (TRMD).


Fluorodeoxyglucose positron emission tomography (FDG PET) was used to assess regional mean relative cerebral metabolic rate for glucose (CMRGlu) in four ROIs (anterior insular, orbitofrontal, anterior cingulate, and dorsolateral prefrontal cortices) at baseline (prior to VNS activation). Depression severity was assessed at baseline and after 12months of VNS using the Hamilton Depression Rating Scale (HDRS), with response defined as ≥50% reduction in HDRS from baseline.


Baseline CMRGlu in the anterior insular cortex differentiated VNS responders (n=11) from nonresponders (n=4) and correlated with HDRS change (r=.64, p=.01). In a regression analysis, lower anterior insular cortex CMRGlu (p=.004) and higher orbitofrontal cortex CMRGlu (p=.047) together predicted HDRS change (R(2)=.58, p=.005). In a whole brain, voxel-wise analysis, baseline CMRGlu in the right anterior insular cortex correlated with HDRS change (r=.78, p=.001).


Sample size was small, limiting statistical power; patients remained on their psychiatric medications; study was open-label and uncontrolled.


This preliminary study suggests that pretreatment regional CMRGlu may be useful in predicting response to VNS in TRMD patients.
Copyright © 2012. Published by Elsevier B.V.
[PubMed - as supplied by publisher]