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

Wednesday, February 22, 2012

Treatment of drug-resistant epilepsy with vagus nerve stimulation - review of 45 cases.

Chin Med J (Engl). 2011 Dec;124(24):4184-8.

Treatment of drug-resistant epilepsy with vagus nerve stimulation - review of 45 cases.


Department of Functional Neurosurgery, Beijing Sanbo Brain Hospital, Capital Medical University, Beijing 100093, China.



Vagus nerve stimulation (VNS) is an alternative treatment for drug-resistant epilepsy (DRE). The study aimed to explore the potential factors of prognosis, safety and effect of VNS treatment in patients with DRE.


We retrospectively examined 45 cases of DRE that received VNS treatment in our center from June 2004 to June 2010 and analyzed the parameters (age of patient receiving VNS, seizure frequency before and after VNS as well as treatment duration) by Student's t test, Fisher's exact and Mann-Whitney U tests, and multivariate Logistic regression.


The overall response rate was 64% (29/45), 67% (6/9) for adults and 64% (23/36) for children, with no significant difference (P = 0.28). Twenty-two cases had been in VNS therapy for over 1 year with a treatment efficacy of 73% (16/22), whereas 23 cases had been in VNS therapy no more than 1 year with a treatment effecacy of 57% (13/23), and has statistically significant difference (P = 0.03). The main side effect included hoarseness of voice and cough. One patient's device was removed due to infection. One patient's VNS was half-way terminated due to seizure aggravation. One patient died due to status epilepticus.


VNS is a safe and effective treatment for DRE. Duration of VNS therapy may be a crucial factor on prognosis.
[PubMed - in process]

Tuesday, February 21, 2012

Expertise in epilepsy treatment: Prof. Dr. med. Hajo Hamer reinforces the scientific advisory board of cerbomed GmbH

Expertise in epilepsy treatment: Prof. Dr. med. Hajo Hamer reinforces the scientific advisory board of cerbomed GmbH

Pressemitteilung von: cerbomed GmbH
(openPR) - ERLANGEN, Germany, 21.02.2012 – In Prof. Dr. Hajo Hamer the medical device company cerbomed GmbH gains a renowned expert in epileptology for its scientific advisory board.

Prof. Dr. Hamer will support cerbomed GmbH in carrying out an international multi-center study to treat drug-resistant epilepsy, using transcutaneous Vagus Nerve Stimulation (t-VNS).

Since April 1st, 2011 Prof. Dr. Hamer has been the new head of the Epilepsy Center at the University Hospital, Erlangen, and a senior physician in the neurological clinic. The emphases of his research are on the investigation of inflammable changes in epilepsy, and on optimizing the care of patients with epilepsy, among others. As part of the interdisciplinary team of the Epilepsy Center Erlangen, he is responsible for treating around 3,000 patients. One of the main emphases of his clinical work is the therapy of hard-to-treat epilepsies.

"In more than 30 percent of all epilepsy patients undergoing an anticonvulsive therapy there is no significant decrease in the frequency of seizures. It is therefore important to explore new forms of therapy. Transcutaneous Vagus Nerve Stimulation could represent a new, non-invasive therapy option for treating drug-resistant epilepsy", says Prof. Dr. Hamer.

"We are very pleased that Prof. Dr. Hamer is supporting us in conducting the multi-center study, which will examine the effectiveness and safety of t-VNS in 70 patients", explains Prof. Dr. Jens Ellrich, Chief Medical Officer at cerbomed GmbH.

Cerbomed GmbH will introduce the t-VNS therapy at the 51st annual conference of the German Society for Epileptology e.V. in Stuttgart, between February 29th and March 3rd, 2012.

Transcutaneous Vagus Nerve Stimulation with NEMOS uses the fact that a branch of the vagus nerve is located directly under the skin in areas of the outer ear and therefore can be stimulated through the skin (transcutaneously) with electrical impulses. For t-VNS cerbomed developed and patented a special stimulator and a dedicated ear electrode. The stimulator, which is connected with the ear electrode, sends out the electrical impulses.

The t-VNS therapy is addressed to patients suffering from various difficult to treat neurological and psychiatric diseases. With NEMOS a targeted stimulation of the vagus nerve gets possible without the need of a surgery.

The German market entry for NEMOS is planned for the third quarter of 2012. NEMOS will then be available for patients suffering from hard-to-treat epilepsies and depressions.

Cerbomed GmbH is an innovative medical device company that concentrates on researching, developing and producing new technologies and products for neuromodulation. The company’s focus is on transcutaneous Vagus Nerve Stimulation (t-VNS), which may offer an attractive therapy option for patients with hard to treat neurological and psychiatric illnesses.

In March 2010 cerbomed received the European clearance (CE mark) for the transcutaneous vagus nerve stimulator NEMOS. In early 2012 two clinical studies will be starting regarding the effectiveness of t-VNS in patients with drug-resistant epilepsy and chronic migraine.

cerbomed GmbH
Dr. Martin Hyca, Director Marketing
Henkestrasse 91
DE-91052 Erlangen
+49 9131 9202 76 30

Using Electricity, Magnets for Mental Illness

The Wall Street Journal

Physicians have known for 2,000 years that electricity could help troubled minds—even before they knew what electricity was. Roman Emperor Claudius pressed electric eels to his temples to quell headaches. Sixteenth-century doctors induced seizures with camphor to treat psychiatric illnesses.

Research is advancing on the use of electricity to treat depression and other mental illnesses. Fisher Wallace Laboratories' cranial stimulator uses alternating current sent through the brain to boost endorphins, serotonin and dopamine, the company says. WSJ's Melinda Beck tries it on.

Now, research is advancing rapidly on a host of far more precise techniques to stimulate or calm the brain with electricity, magnets or even ultrasound and infrared waves. Most of the therapies target severe, resistant depression—a problem for nearly seven million Americans. But some are also showing promise for treating obsessive-compulsive disorder, panic disorders, schizophrenia, addictions and memory problems.

Some battery-operated brain stimulators are even being marketed for home use, so patients can treat their own depression and insomnia, though some neurologists say the evidence for these devices is thin.

"There's a stampede of these new technologies," says Mark George, a psychiatrist and neurologist at the Medical University of South Carolina and editor-in-chief of the journal Brain Stimulation. "There are all these different ways to get into the brain and figure out how to change the circuits."
Indeed, there's a growing consensus among neuroscientists that many psychiatric illnesses stem from problems in the brain's electrical circuits.

"In psychiatry, we have gone from 'It's all about your mother' a la Freud to the concept of chemical imbalances in the brain to the current focus on dysfunctional brain circuits and genetics," says Emory University neurologist Helen Mayberg, a pioneer in brain imaging and depression.

But much still isn't known, she adds. "What regions are in the game? How are they wired up? Which ones are most important to which problem?"

Using fMRIs, PET scans and other imaging technologies, neuroscientists also hope they can someday predict which patients will respond to which treatments—without having to endure years of trial and error.

At the same time, electroconvulsive therapy (ECT), the decades-old practice of using electric current to trigger a brief brain seizure, is set to face new scrutiny at a Food and Drug Administration hearing later this month. The treatment was grandfathered by the agency in 1976 without the kind of lengthy, expensive clinical trials required today. With some longtime critics charging that ECT causes cognitive defects and dementia in patients, the FDA could require that the few makers of ECT equipment run such studies now—but the companies have warned that they can't afford such research.

"The reason we still have ECT is that we need it. It's the most rapidly acting and effective approved treatment we have for major depression," says Duke University Medical Center psychiatry chairwoman Sarah Lisanby, one of many who fear that suicides might rise if ECT were unavailable. Once known for blunting personalities and breaking bones, ECT has become much safer in recent years. Patients now undergo general anesthesia, the current is far more controlled and it is often applied only on one side to minimize memory loss. More than 100,000 ECT procedures are conducted annually in the U.S.

Of the new brain-stimulation therapies, the most developed is Transcranial Magnetic Stimulation (TMS), cleared by the FDA in 2008 to treat patients who had failed on one anti-depressant. A technician holds a magnetic coil against the patient's forehead. Short electromagnetic pulses, about the strength of an MRI, travel through the skull and stimulate nerve cells in the brain's dorsal lateral prefrontal cortex, an area thought to be involved in depression. Patients feel only a slight tingling; they typically undergo 40-minute treatments daily for four to six weeks.

Peer-reviewed studies show that TMS results in remission in about 30% of depressed patients, only half the rate of ECT but twice as good as a placebo. Common side effects include headaches and scalp irritation; long-term effects are still unknown. To date, about 3,000 patients have been treated with TMS, according to Neuronetics Inc., which makes the device, and 70 insurers have covered on a case-by-case basis.

Two brain-stimulation techniques require surgery:

With Vagus Nerve Stimulation (VNS), a pacemaker-like device is implanted near the base of the neck to deliver mild electrical pulses to the vagus nerve, which tells the brain what's going on in the rest of the body. A study in the journal Appetite in the fall found that when VNS devices were implanted in obese miniature pigs, they ate fewer sweet foods and lost weight while those with sham devices got more obese. The device, made by Cyberonics of Houston, was cleared by the FDA in 1997 to treat epilepsy and in 2005 for resistant depression, but insurance coverage is still minimal.

In Deep Brain Stimulation (DBS), a pair of electrodes is implanted in the brain and are connected by wires to a pair of pulsing devices in the chest. The electrodes emit a sort of jamming signal to brain circuits thought to be involved in depression. Some 60,000 patients worldwide use DBS to treat Parkinson's disease, a brain disorder that impairs motor skills. But with depression, researchers aren't yet sure where the target area should be.

Both VNS and DBS run some surgical risks, including infection and stroke. Some Parkinson's disease patients with DBS have also become manic and gone on gambling sprees.

Many other technologies are also being investigated—including Magnetic Seizure Therapy, which uses magnets to create more controlled, localized types of seizures and Transcranial Pulsed Ultrasound, which could let doctors focus energy deep into brain circuits without the risk of implanting electrodes. Still other researchers are using optogenetics, quick bursts of colored light, to study how brain cells communicate with each other.

Meanwhile, another older technology is getting new attention. Cranial Electrotherapy Stimulation (CES), which sends very weak microcurrent into the brain, was widely used in Russia in the 1940s as a sleep aid. Several battery-powered CES devices won FDA clearance to treat depression, anxiety and insomnia in the 1980s and 1990s, largely because they were similar to other grandfathered devices, and some have been quietly selling to home users ever since. Electromedical Products International Inc. has been selling its Alpha-Stim devices for both pain relief and anxiety and depression since 1981. Many users are military veterans.

Last fall, a newcomer in the field, Fisher Wallace Laboratories, launched a YouTube campaign lampooning the side effects of anti-depressants and promoting its cranial stimulator as an alternative. Powered by two AA batteries, the device was sends 1 milliampere of alternating current—1/1,000th the voltage used in ECT—through a patient's head via small, wet pads placed at the temples. The company recommends using the device 20 minutes once or twice a day for 30 to 45 days, and several times a week afterward.

[HEALTHCOL] Associated Press
In this 1942 photo, a patient at Patton State Hospital in San Bernardino, Calif., is treated with electroconvulsive therapy (ECT). The FDA may require equipment makers to conduct new safety studies.

The company, founded by electronics entrepreneur Charles Avery Fisher and Martin Wallace in 2007, says the device works by boosting endorphins, serotonin and dopamine and reducing cortisol
Does it work? Columbia University psychiatrist Richard P. Brown says he has used the device with 400 severely depressed patients and that more than 70% find relief—about twice the rate of anti-depressants. "I'm seeing some patients smile for the first time in 20 years," says Dr. Brown, who, like other doctors interviewed for this column, has no financial ties to the company.

Other neuroscientists are wary. "In my assessment of the literature, the level of evidence to support those kinds of claims is not sufficient at this point," says Dr. George.

Dr. Mayberg adds, "It's not a great idea to be exposing your brain to electricity of any type without medical supervision."

Much of the clinical data supporting CES devices is outdated; a few small placebo-controlled trials of the Fisher Wallace device are planned at Harvard, Columbia and the University of Toledo.
"I think a lot of people who use it will tell you it can be very helpful," says Andres San Martin, a Columbia psycho-pharmacologist who says about 50 of his patients use the device, along with antidepressants. Some use it just half the year for Seasonal Affective Disorder, and some have found it helpful in quitting smoking. "But I am looking forward to the double-blind placebo-controlled trials," he says.