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Monday, June 30, 2014

Henry Ford Seeks Tinnitus Patients for Vagal Nerve Stimulation Clinical Trial

Henry Ford Seeks Tinnitus Patients for Vagal Nerve Stimulation Clinical Trial

Released: 6/24/2014 2:00 PM EDT
Source Newsroom: Henry Ford Health System

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Newswise — DETROIT – Henry Ford Health System, in collaboration with Wayne State University, is one of four sites worldwide involved in a clinical trial that will test a device that uses nervous system stimuli to rewire parts of the brain, in hopes of significantly reducing or removing tinnitus, a chronic ringing of the head or ears that affects more than 50 million people.

The National Institutes of Health-supported study will examine the effectiveness and safety of the vagal nerve stimulator (VNS) – a small, surgically implanted device that uses electrical impulses to stimulate the vagus nerve – to treat tinnitus.

Henry Ford is currently recruiting patients who have experienced tinnitus for at least one year to take part in the blinded, two-arm study for approximately 10-weeks, with long-term follow-up for those who continue to receive therapy.

“There is still no known cure for tinnitus, so we’re continuously working to find new treatment options that are safe, effective and help improve the quality of life for patients with tinnitus,” says study lead investigator Michael D. Seidman, M.D., director of the Division of Otologic/Neurotologic Surgery in the Department of Otolaryngology-Head & Neck Surgery at Henry Ford.

Several conditions have been shown to trigger or worsen tinnitus: Exposure to loud noises, hearing loss, tumors of the hearing/balance nerve, wax build-up in the ear, ear or sinus infections, head and neck trauma, and certain disorders such as hypo- or hyperthyroidism, Lyme disease, fibromyalgia and thoracic outlet syndrome.

While the exact physiological cause of tinnitus is not known, previous research suggests tinnitus might be the “result of the brain trying to regain the ability to hear those lost frequencies by turning up the signals of neurons in neighboring frequencies.” Those changing brain patterns may be to blame for the phantom sounds of tinnitus.

Similar to a pacemaker for the heart, the VNS uses electrical impulses to send signals along the vagus nerve to the brainstem, taking advantage of the ability of the brain’s neurons to reconfigure their connections and behavior (neuroplasticity).

The device is surgically implanted under the skin on the chest. A wire is then threaded under the skin to connect the device to the vagus nerve, a large nerve that extends from the head and neck to the abdomen and commands voice (vocal cord movement) and involuntary body movements like as heart rate and food digestion.

Once the device is active, patients will undergo combined audio therapy. During therapy, patients wear headphones and listen to a series of single frequency tones, paired with stimulation, to encouraging neurons in the brain to change their connections and behavior. The 2.5-hour session will take place five days a week during the course of 4 weeks, initially in clinic and then at home.

To test the effectiveness of VNS to treat tinnitus, patients in the study will be randomly selected to take part in one of two groups:
• One group will get the VNS and tone test treatment immediately
• The other group will get the VNS, but “sham” therapy that is not expected to have a therapeutic benefit

After six weeks, both groups will receive active test treatment.

VNS is currently approved by the U.S. Food and Drug Administration for use in the treatment of epilepsy and depression. More than 60,000 devices have been implanted in patients with epilepsy during the past 15 years.

Study participants

The Henry Ford study is seeking patients, ages 22-65, who have been diagnosed with subjective tinnitus due to hearing loss with sensorineural aspects and at least some tonal quality of the tinnitus. Participants must have experienced tinnitus (unilateral or bilateral) for at least one year.

Those selected for the study must agree to no tinnitus treatment for at least four weeks prior to entering the study, as well as be willing to comply with all study-related procedures during the course of the clinical trial.

Patients do NOT qualify for the study if they have/are:
• Acute or intermittent tinnitus
• Severe hearing loss (defined as more than an 80 dB HL)
• Meniere’s disease, ear tumors, or evidence of active middle ear disease (such as fluid, infection, tumor, mass).
• Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug
• Pregnant, plan to become pregnant or breastfeeding during the study
• Medications that influence neuromodulators
• Significant cardiac medical history
• Taking meds known to worsen tinnitus
• Taking meds that impact neuromodulation

For more information about the study, visit To enroll, prospective participants should call (248) 661-7211.

Sunday, June 29, 2014

Watching individual neurons respond to magnetic therapy

Watching individual neurons respond to magnetic therapy

Watching individual neurons respond to magnetic therapyEnlarge

The light grey coil on the left is a conventional, commercially available TMS coil. The black coil on the right is the new, innovative version designed to fit a smaller non-human primate's cranium and work with the neural monitoring device. Credit: Warren Grill

Engineers and neuroscientists at Duke University have developed a method to measure the response of an individual neuron to transcranial magnetic stimulation (TMS) of the brain. The advance will help researchers understand the underlying physiological effects of TMS—a procedure used to treat psychiatric disorders—and optimize its use as a therapeutic treatment.

TMS uses magnetic fields created by electric currents running through a wire coil to induce neural activity in the brain. With the flip of a switch, researchers can cause a hand to move or influence behavior. The technique has long been used in conjunction with other treatments in the hopes of improving treatment for conditions including depression and substance abuse.

While studies have demonstrated the efficacy of TMS, the technique's physiological mechanisms have long been lost in a "black box." Researchers know what goes into the treatment and the results that come out, but do not understand what's happening in between.

Part of the reason for this mystery lies in the difficulty of measuring neural responses during the procedure; the comparatively tiny activity of a single neuron is lost in the tidal wave of current being generated by TMS. But the new study demonstrates a way to remove the proverbial haystack.

The results were published online June 29 in Nature Neuroscience.

"Nobody really knows what TMS is doing inside the brain, and given that lack of information, it has been very hard to interpret the outcomes of studies or to make therapies more effective," said Warren Grill, professor of biomedical engineering, electrical and computer engineering, and neurobiology at Duke. "We set out to try to understand what's happening inside that black box by recording activity from single neurons during the delivery of TMS in a non-human primate. Conceptually, it was a very simple goal. But technically, it turned out to be very challenging."

Watching individual neurons respond to magnetic therapyEnlarge

The interdisciplinary team that developed the method to record an individual neuron's response during transcranial magnetic stimulation. Clockwise from top left: Michael Platt, director of the Duke Institute for Brain Science, Center for …more

First, Grill and his colleagues in the Duke Institute for Brain Sciences (DIBS) engineered new hardware that could separate the TMS current from the neural response, which is thousands of times smaller. Once that was achieved, however, they discovered that their recording instrument was doing more than simply recording.

The TMS magnetic field was creating an electric current through the electrode measuring the neuron, raising the possibility that this current, instead of the TMS, was causing the neural response. The team had to characterize this current and make it small enough to ignore.

Finally, the researchers had to account for vibrations caused by the large current passing through the TMS device's small coil of wire—a design problem in and of itself, because the typical TMS coil is too large for a non-human primate's head. Because the coil is physically connected to the skull, the vibration was jostling the measurement electrode.

The researchers were able to compensate for each artifact, however, and see for the first time into the black box of TMS. They successfully recorded the action potentials of an individual neuron moments after TMS pulses and observed changes in its activity that significantly differed from activity following placebo treatments.

Grill worked with Angel Peterchev, assistant professor in psychiatry and behavioral science, biomedical engineering, and electrical and computer engineering, on the design of the coil. The team also included Michael Platt, director of DIBS and professor of neurobiology, and Mark Sommer, a professor of biomedical engineering.

They demonstrated that the technique could be recreated in different labs. "So, any modern lab working with non-human primates and electrophysiology can use this same approach in their studies," said Grill.

The researchers hope that many others will take their method and use it to reveal the effects TMS has on neurons. Once a basic understanding is gained of how TMS interacts with neurons on an individual scale, its effects could be amplified and the therapeutic benefits of TMS increased.

"Studies with TMS have all been empirical," said Grill. "You could look at the effects and change the coil, frequency, duration or many other variables. Now we can begin to understand the physiological effects of TMS and carefully craft protocols rather than relying on trial and error. I think that is where the real power of this research is going to come from."

More information: "Simultaneous transcranial magnetic stimulation and single neuron recording in alert non-human primates." Mueller, J.K., Grigsby, E.M., Prevosto, V., Petraglia III, F.W., Rao, H., Deng, Z., Peterchev, A.V., Sommer, M.A., Egner, T., Platt, M.L., Grill, W.M. Nature Neuroscience, June 29, 2014. DOI: 10.1038/nn.3751

Journal reference: Nature Neuroscience

Monday, June 23, 2014

Long-term VNS Safe, Effective for Resistant Depression

Medscape Medical News from the

This coverage is not sanctioned by, nor a part of, the American Society of Clinical Psychopharmacology.


Medscape Medical News > Conference News

Long-term VNS Safe, Effective for Resistant Depression

Fran Lowry

June 23, 2014


Drug & Reference Information

HOLLYWOOD, Florida — Long-term use of vagal nerve stimulation (VNS) as an adjunctive therapy is safe and effective in patients with treatment-resistant depression (TRD), new research suggests.

Results of a 5-year observational study show that add-on VNS was safe and resulted in significantly better response and remission rates than usual treatment with no VNS in patients with TRD.

"We have 5 years of data for people with treatment-resistant depression implanted with VNS compared with a comparable population who do not have VNS, and these data show a 20- to 30-point separation both in response rates and remission rates on the Montgomery-Åsberg Depression Rating Scale [MADRS]," Scott Aaronson, MD, director of clinical research at Sheppard Pratt Health System, Baltimore, Maryland, told Medscape Medical News.

"As I was analyzing the data for the company, I was just getting blown away by the amount of separation that we are seeing. It's very rare in psychiatry to see 5-year data about anything, so this is very unusual, and the results are very positive," Dr. Aaronson said.

The findings were presented here at the American Society for Clinical Psychopharmacology (ASCP) 2014 Annual Meeting.

Insurers Won't Cover

An implantable device that is used for treatment-resistant epilepsy, VNS is also approved by the US Food and Drug Administration for treatment-resistant depression.

Dr. Scott Aaronson

However, medical insurers do not pay for VNS, and this has limited its use, Dr. Aaronson said.

"Insurers have not been very receptive to covering it, but we are hopeful that these kinds of data will convince them that this is a very valuable addition and that it should be a covered service," he said.

Dr. Aaronson and his team analyzed data obtained from 61 US centers that enrolled adults with chronic depression of at least 2 years' duration or who had recurrent depression that included at least 3 or more major depressive episodes. The study period was from 2006 to 2010.

All patients had to have experienced 4 or more adequate but not successful antidepressant treatments and then opted either to be implanted with VNS (n = 494 patients) or to receive treatment as usual (TAU, n = 301 patients) at the time of enrollment.

The average age of the patients at study entry was 49 years, the age at initial diagnosis of depression was 29 years, and the average number of failed treatments was 8, Dr. Aaronson said.

Patients in the VNS arm were more likely to experience remission than patients in the treatment-as-usual arm during the 5-year period, as shown on the MADRS scale (43.1% for VNS vs 22.8% for treatment as usual; P < .0001).

Remission also lasted longer for the VNS group than the treatment-as-usual group, as determined on the basis of MADRS scores (40 months for VNS vs 19 months for treatment as usual; P < 0.0065).

Patients in the VNS arm showed a greater response than patients in the treatment-as-usual arm during the 5-year study period with regard to the CGI-I scale as well (75.7% for VNS vs 47.1% for treatment as usual; P < .0001).

Similarly, VNS patients had a consistently better quality of life as rated by the Quality of Life, Enjoyment and Satisfaction Questionnaire than did patients receiving treatment as usual (P < .0001).

Encouraging Results

"The results of this study are encouraging," Philip Gerretsen, MD, from the Center for Addiction and Mental Health and the University of Toronto, Canada, told Medscape Medical News.

"However, the findings require replication with a randomized controlled trial to include a sham condition, as there is a high likelihood of a placebo effect both in this population and with an invasive procedure such as VNS," Dr. Gerretsen, who was not part of the study, said.

The study was sponsored by Cyberonics, Inc. Dr. Aaronson reported financial relationships with Sheppard Pratt, Genomind, Sunovion, and Takeda/Lundbeck. Dr. Gerretson reported no relevant financial relationships.

American Society of Clinical Psychopharmacology (ASCP) 2014 Annual Meeting. Abstract 34. Presented June 16, 2014.

Implant helps Olean woman with epileptic seizures

Implant helps Olean woman with epileptic seizures

Megan Blafkin

Megan Blafkin

Kate Day Sager/Olean Times Herald

Megan Blafkin, 55, of Olean has been able to manage epileptic seizures,

which had been a regular part of her life, through the use of a Vagus Nerve

Stimulation implant in her chest.


Posted: Sunday, June 22, 2014 11:40 pm | Updated: 11:43 pm, Sun Jun 22, 2014.

Implant helps Olean woman with epileptic seizures By Kate Day Sager/Olean Times Herald Olean Times Herald

OLEAN — During a class at the former Allegany High School in the early 1970s, Megan Blafkin found out she couldn’t hide her epilepsy from her peers, teachers or community anymore.

Then 15 years old, she fell off a classroom chair, began convulsing with a grand mal seizure and had to be taken to the former St. Francis Hospital for treatment. While it was the worst seizure for her at the time, the uncertainty of when she would have another epileptic episode would follow her for the next 25 years.

Ms. Blafkin’s life was turned around in 1997 when a Cyberonics Vagas Nerve Stimulation (VNS) device was implanted in her chest and helped stop or shorten her seizures. Ms. Blafkin, who has spoken to neurologists at medical conventions about her improved health from use of the VNS, said she also wanted to share her story with her hometown community.

“I grew up in Allegany and when I was 20 months old I had a convulsion from running a high fever,” she recounted. “Mom and dad (the late Margaret and Tom Geary) took me up to St. Francis Hospital and I convulsed for six and a half hours. They went to my parents and said, ‘She’s not going to make it.’”

The child proved them wrong and later returned home with her parents with no diagnoses on what may have induced the convulsions. As a result, her undiagnosed epilepsy and the accompanying partial complex, or petit mal, seizures were something she kept secret from her family and everyone else for several of years.

“I didn’t know how to go to my mom and say, ‘I’m deathly afraid of something and I don’t know what it is,’” she recalled. “I kept them hidden. I’d get what’s called an aura or a sensation” prior to a partial complex seizure. Each time she’d feel the sensation, she would leave the dining room table at home or the classroom in school and go to the bathroom. Once there, she’d sit on the toilet seat and endure the seizure until it subsided.

“I couldn’t see, I couldn’t hear and if I talked I didn’t know what I said,” she said. At the age of 15, the concealed illness ended with her grand mal seizure in class. After a 10-day stay in the hospital, however, she returned home and received some advice from her mother.

“She told me, ‘Don’t tell anybody you’ve got this because they won’t understand,’” Ms. Blafkin said. “It was just in the early ’70s and (epilepsy) was unacceptable.”

With that advice in hand, she kept her condition to herself and didn’t explain to school staff or others why she had convulsed.

“I got back to school and got kidded and harassed so bad,” she recalled. And while some medications helped her control the grand mal seizures, the doctors couldn’t  find anything that would help the partial complex seizures.

“In 1980 when I moved to California, my mom told me I couldn’t put (the epilepsy information) on my application or no one would hire me,” she said. With that in mind, she applied for an insurance company job where she adjusted claim forms. She did so well at the job that she was promoted three times in one year. When her annual evaluation came up, she shared her medical history with the company’s owner, who looked at her job record and agreed to provide medical insurance for her condition.

“Every job I had after that I had to show them I could do the job, and then I’d let them know” about the epilepsy, she said. Until that happened, however, she would have to go to the restroom at the workplace when she felt the onset of a seizure and wait it out on the toilet.

Over the next 15 years, she married, had a child and moved to Nevada with her family.

All the while, she continued taking her medications for the grand mal seizures, but still saw no hope for controlling the partial complex seizures. During a visit to a neurologist’s office in Nevada in 1997, that all changed when she learned of the VNS implants.  

An encounter with a representative with Cyberonics would lead to an implant operation which, in turn, changed her life.

“I was having over 100 petit mal seizures a month and that went down to 10 or 15 a month,” she said. “It was a major, major difference.”

Since that time, she has had two implant replacements to replace devices that had worn out from age. She also had brain surgery four years ago that helped repair some of the damage suffered from the seizures. She retired early because doctors determined stress also could create the onset of seizures.

Ms. Blafkin said when she has the tell-tale symptoms of a seizure, she can avoid or lessen the episode by a simple procedure done with her implant and a magnet device she carries at all times.

A Cyberonics representative explained that patients and their caregivers use the external magnet by briefly holding it over the implant site to produce an extra dose of stimulation.

“This extra dose can potentially shorten or stop a seizure or decrease its intensity or the recovery period,” the representative said.

He further noted VNS Therapy is a neurostimulation treatment option that sometimes is described as a pacemaker for the brain.

“VNS Therapy may be added to medications to help improve seizure control,” the representative added. “A thin thread-like wire, or lead, connected to the generator, runs under the skin and is attached to the left vagus nerve in the neck. The device delivers mild, intermittently pulsed signals to the vagus nerve, which then activates various areas of the brain.”

The official said more than 70,000 patients with epilepsy have been treated worldwide with VNS Therapy since it was approved for use in the United States in 1997.

Ms. Blafkin’s success story was so compelling to officials with Cyberonics that she was asked to speak at a neurological convention in Nevada a number of years ago. While sharing her story with the specialists, she discovered many hadn’t heard of the therapy.

“None of the neurologists knew about the thing or how to run it,” she said.

On a current note, Ms. Blafkin said she moved back to the Olean area three years ago to be closer to family members, including her sisters Grace Nolan and Maureen Luther. She has to travel to Rochester for appointments with neurologists who can monitor her implant, prescribe medication and provide treatment.

She felt compelled to spread the word on her implant because it has helped her take control of her life.

“I want people (and professionals) to know about this,” she said. “So many people don’t realize what the implant, alone, can do.”

(Contact reporter Kate Day Sager at

Saturday, June 21, 2014

Carrollton resident overcomes epilepsy, wants to help others

Carrollton resident overcomes epilepsy, wants to help others




Posted: Friday, June 20, 2014 4:13 pm

Carrollton resident overcomes epilepsy, wants to help others Josh Bowe | Star Local Media | 0 comments

At one point, Melanie Stone figured she’d always live with seizures. It would just be part of her life.

“I just figured, I’ll just go along with my life and, after awhile I’ll have a seizure, and that’s the way it is,” the Carrollton resident said.

Stone, 37, was diagnosed with epilepsy in her mid-20s. She had experienced anxiety and migraines along with twice-daily seizures. It was something she just learned to live with.

Even after she had part of her brain removed during surgery, it only eliminated 80 percent of the seizures. She eventually learned to coexist with it.

In 2012, a doctor recommended a new, non-drug method called VNS therapy – an implantable medical device. After years of multiple medications, doctors eventually got her down to one. Now, Stone is seizure-free.

With her health back, she’s now going to use her experience to help others. She’s currently in school to become a neurodiagnostic technician.

“It is amazing,” she said. “Sometimes I look back on it, and it doesn't seem real. I’m so grateful. My goal in life is to go out there and educate people, because it’s a misunderstood condition.”

It wasn’t an easy journey for Stone – far from it. Once she was diagnosed in her mid-20s, she exhausted almost every method of treatment. She’s had three brain surgeries and has been on up to eight medications at one time.

Nothing seemed to totally end her seizures. She said she remembers the helpless feeling that came along with the disease.

It didn’t help that Stone moved from Arizona to Carrollton, thus being in a new place and trying to get used to it along with the condition.

“I wasn't driving and had to live with my parents; I didn't know anyone,” she said. “I just felt completely like I was defective.”

It made her wonder if she would ever live a truly normal life. When she found out about the VNS therapy she didn’t hesitate.

“I felt comfortable it wouldn't make it worse,” she said. “I figured anything we can try to make me seizure-free, I’ll try it. I said, ‘let’s do it.’”

A few months later, she immediately noticed the change. Down to one medication, she’s currently living seizure-free. Her change in quality of life has inspired her to use her story to help others, she said.

Stone said epilepsy is a disease that doesn’t have a lot of public awareness, but it’s crippling many lives. She hopes to use her knowledge to help people suffering how she suffered.

“I know what it feels like,” she said. “There’s that feeling that you can never go to school, get married, be independent and have a good life.

“I just want to be there and hope to inspire people and to tell them that you may have epilepsy but it doesn't have you.”

She’s currently on track to graduate in 2015 and become a neurodiagnostic technician. Being on the other side has definitely opened her eyes to the disease.

“I’m learning so much more detail,” she said. “Now I’m being the person that’s helping, looking up the studies. It’s different to see it from that side. It’s been amazing.”

Stone said she feels blessed to be put in this situation. She doesn’t take that lightly, she said. Stone said she understands that there are plenty with epilepsy that won’t have the happy ending she’s discovered.

So in the meantime, she said she’s going to try and give back as much as she can.

“If I hadn't gotten the treatments, I would have been severely brain damaged,” she said. “It could have been fatal.

“People can die from epilepsy. I feel fortunate that they were able to give me the life that I thought that I couldn’t have.”

Sunday, June 15, 2014

Project coordinator slams VNS study

  1. Mental Health

Project coordinator slams VNS study - Part 1

See also

Vagus nerve stimulation, or VNS, is marketed as a treatment for severe depression.

Vagus nerve stimulation, or VNS, is marketed as a treatment for severe

Zoom in

Jenny Westberg Portland Mental Health Examiner

February 27, 2012

The device manufacturer swears it’s effective. The FDA approved it. But is there any evidence for vagus nerve stimulation (VNS) for treatment-resistant depression?

Susan Ricketts contacted me after reading “Vagus nerve stimulation (VNS) for depression: Does it work?” on this site. Now, in an exclusive interview, Ricketts describes her experience as Project Coordinator on the D-02 clinical trial of VNS for depression. It was the single randomized, controlled trial submitted to the FDA, but one Ricketts says was so poorly managed she ended up walking away from the job, minus a paycheck, but with integrity intact.

Excerpts from the interview begin in Part 2 of this article; first, some background information:

What is vagus nerve stimulation?

In VNS, a device is surgically implanted in the patient’s neck and connected to the vagus nerve. When switched on, the device shoots electrical impulses through that nerve and into the brain.

VNS has been shown to be effective in controlling seizures in severe cases of epilepsy, but there has never been solid evidence it works on depression.

Even so, it was approved by the FDA for treatment-resistant depression in 2005, over loud objections from FDA staff and the consumer group Public Citizen, among others. The approval process raised so many red flags it was the subject of a U.S. Senate investigation.

Many people think VNS is a radical but effective last-ditch treatment for depression that responds to nothing else. That belief is due largely to long-term and continuing marketing efforts by Cyberonics, Inc., the device manufacturer.

Cyberonics has managed to get its own press releases and a few vaguely scientific studies onto high-profile health websites. Unfortunately, that’s where many people go for health information, not realizing these sites are often used as free advertising space by pharmaceutical and device manufacturers with a serious financial stake in moving product off the shelves.

Understanding scientific studies

To understand why the evidence falls short, it’s important to know a few buzzwords.

In a randomized, controlled clinical trial, scientists compare the effects of a treatment on two randomly populated groups of patients, one group receiving the treatment being tested and the other group, called a control group, not getting the treatment. The control group receives a placebo or “sugar pill” (in the case of VNS, an inactive device), because patients who know whether they are being treated or not might be subject to the “placebo effect” and show improvement (or not) due to their own expectations.

Researchers try to eliminate every possible variable that could influence the results other than the treatment itself.

To envision this, imagine you are trying to find out if orange popsicles melt faster than green popsicles. You lay the popsicles out in two groups and observe them, and note that the orange popsicles do, in fact, melt much faster than green ones. Then you realize the group of orange popsicles was in direct sunlight. Oops! That’s an example of a variable affecting your results. Good thing you didn’t rush an article to the scientific journals.

Most VNS trials for depression were decidedly of the hot-popsicle type. In one study, for instance, subjects were allowed to use treatments other than VNS during the study, and to switch between the additional treatments. Even if the results of such a trial showed depression was relieved, it would be impossible to tell whether it was due to VNS, the add-on treatment, the combination – or pure chance.

Behind the scenes

Four years after VNS’s approval for depression, a report to Oregon Health & Science University’s Center for Evidence Based Policy found only one randomized, controlled study in the literature, and that study showed no benefit for VNS.

As it happens, that single trial, the D-02 study, was the one Susan Ricketts worked on. What she saw shocked her.

See Part 2

Project coordinator slams VNS study – Part 2

See also

Depression affects approximately 121 million people worldwide, according to the World Health Organization.

Depression affects approximately 121 million people worldwide, according to the World Health

February 27, 2012

When the FDA evaluated clinical trials on vagus nerve stimulation (VNS) for depression, they were presented with written reports. Susan Ricketts, on the other hand, was behind the scenes. She was Project Coordinator on the D-02 clinical trial, the only study rated above “poor” in a report prepared for Oregon Health & Science University.

Ricketts had worked on numerous studies previously, and she was unprepared for Cyberonics’ lack of professionalism.

Susan Ricketts: “When I started on the D-02 VNS trial, I’d had long-term research jobs, including eght years at Dartmouth and two and a half years at Regents Hospital. But I lasted six months [on the VNS trial], because it was the most poorly run trial I’ve ever seen.

“I was the Project Coordinator. The patients had already been recruited, and randomly assigned to receive the VNS implant. The implants were either turned on or turned off during the course of the trial, and we followed their progress and symptoms throughout. I was the unblinded person on the trial, which means I was the one who knew whether a person's device was turned on or turned off. I actually manipulated the software to turn it on or off.

“One of the first things that happened was when I went in, in my estimation the records that patients had filed were very disorganized, in disarray. So one of my first goals was to get the records in order.

"In a clinical trial – let’s say someone’s having a symptom, even a cold or flu symptom – you have to follow those symptoms very carefully, and track pain, severity, how long it lasted – because that’s how you track side effects, or adverse effects.

“It casts doubt on all clinical trials, all drug trials, all device trials.” – Project Coordinator Susan Ricketts

“Because they’d already been through three project coordinators, the tracking of patients’ histories throughout the trial was really atrocious. I called up patients to verify information; I went back with patients through their charts to make sure all the information was complete.

“The principal investigator should be on top of these things, and certainly the people from [device manufacturer] Cyberonics, who come through and review the records – they should have been on top of this. It never should have been as bad as what I saw.

“Another thing, during a study when the language in a consent form changes, you have to make sure that every person in the study reads that new consent form and signs off on it. That was not being done consistently.

“Cyberonics should have been there on a regular basis, making sure those records were clean and complete, and making sure those consent forms were signed.”

Q. Because ideally, they want an absolutely flawless study ?

“Exactly! They’re having to report to the FDA. And my feeling was, if the FDA had come in and done an audit, they would have failed it."

Q. Reading about the FDA approval, there were reports that Cyberonics people were bullying the FDA. Did you see any of that behavior?

“That’s actually what brought me to your article. And those later reports – it just brought back that feeling, that this was a company that was literally shoving its way through approval. Cyberonics was a bully; the people that worked for them were bullies.”

Q. What were your concerns regarding the integrity of results?

“Before I left, when I made the decision to leave, I just kind of looked at the records and reviewed people’s scores.

“To make [people with depression] think VNS is scientifically proven to help them? It’s an atrocity.” Project Coordinator Susan Ricketts

“I could see, even without a statistical analysis – and by the way, I do have training in statistical analysis – you could tell that, during the 12-week trial, there wasn’t any difference in depression scores between people who had the device turned on, or not. The 12-week efficacy study was just not going to show any results.” (Ricketts was right.)

“I was trained in research, worked in research all my life, and I have great respect for the way people conduct research. And to see Cyberonics get away with this – it just casts doubt on all clinical trials, all drug trials, all device trials – everything’s suspect when something like this goes through with very little scientific evidence."

Q. Cyberonics continues even now to say their device has been proven to be a success.

“I think there’s a great bias against psychiatry and mental health. We wouldn’t be pushing a chemotherapy drug that didn’t work; we wouldn’t be pushing a heart stent that didn’t work.

“We’re talking about people who have treatment-resistant depression. They’ve failed at least two other methods, they've tried drugs, psychotherapy, even ECT.

"These are people for whom we should have tremendous compassion. And to make them think that this device is going to help them? And that it’s scientifically proven to help them? It’s an atrocity."


Thursday, June 12, 2014

Billions in Medicare Advantage Overcharges Probably Gone Forever



Image: UnitedHealth Group Inc.

 Jim Mone / AP file 4 days


Billions in Medicare Advantage Overcharges Probably Gone Forever

By  Fred Schulte, Center for Public Integrity

Billions in Medicare Advantage Overcharges Probably Gone Forever

By  Fred Schulte, Center for Public Integrity

This story was published by The Center for Public Integrity, a nonprofit, nonpartisan investigative news organization in Washington, D.C.

Four years ago, Medicare auditors came to an alarming conclusion: the federal government shouldn’t have paid a half-dozen insurance plans hundreds of millions of dollars to treat seniors in especially poor health.

The findings signaled that billing errors could be deeply rooted within private Medicare Advantage plans -- which contract with the federal government to care for nearly 16 million elderly Americans -- and that these abuses could be wasting taxpayer dollars at a ferocious clip.

Medicare expects to pay higher rates for legitimately sicker people who may require expensive care. But the auditors concluded that all six health plans they visited couldn’t justify the money they took in for 40 percent or more of their patients. That triggered whopping overpayments which auditors pegged at nearly $650 million for 2007 alone -- just for those six plans.

One major Texas health plan was paid to care for a man it said had brain cancer. But his medical file showed he was treated for an enlarged prostate, a common ailment that didn’t merit any added payment, auditors wrote.

In Arizona, a health plan collected thousands of dollars from Medicare to treat congestive heart failure in a patient seen for knee pain, according to auditors. In Pennsylvania, a person treated for blurry vision was charted as having serious heart disease. The audits referred to these errors as “unsupported diagnosis coding.”

It took years for the Department of Health and Human Services inspector general to publish those findings; and government officials have yet to pry back more than a tiny fraction of the disputed money, the Center for Public Integrity has learned.

And despite the bundle of taxpayer dollars on the line, the HHS inspector general didn’t do any more audits, and decided in 2013 to scrap similar future reviews as part of a budget cut.


Robert Trusiak, a former Department of Justice prosecutor, said that “at the very least” federal officials should have demanded refunds from the health plans and lowered the boom on any plan caught “gaming” Medicare.

“The dollars here are huge,” he said.

No company has admitted intentionally “gaming” the system, and the audits do not attempt to assign blame.

The money’s not likely to be returned. The Center for Public Integrity’s yearlong investigation of the Medicare Advantage industry found that federal officials over the past decade have missed multiple opportunities to corral tens of billions of dollars in overcharges and other billing errors tied to a complex payment formula known as a “risk score.”

Read the Center for Public Integrity’s version of this article.

Health plans collect medical data that is used to compute the health risks for each patient enrolled, but there’s been little to deter plans from increasing the resulting “risk scores.”

When risk scores overstate a patient’s illness, the plans make more money from Medicare. There’s little chance patients or the public will find out when this happens because federal officials have kept most audit results confidential.

Washington health-care lawyer Thomas C. Hill said insiders have known of “significant problems” with Medicare Advantage billing practices for years. But they’ve received scant public notice because neither industry nor government has much to gain by letting the secrets spill out, he said.

“The government isn’t in the best light when there’s that high an error rate,” Hill said. “They are reluctant to expose that to the world.”

Click here to see the Center for Public Integrity's Medicare Advantage explainer.

Officials from the HHS IG's office defended the findings in the half-dozen audits, but declined to comment beyond that. Officials from the Centers for Medicare and Medicaid Services (CMS), the HHS agency that actually runs the program, declined to comment at all, despite numerous requests.

Click here to see how changes to a risk score can boost costs.

Big Scores

Medicare unveiled risk scores in 2004. Congress wanted to systematically pay more for people with chronic or costly diseases, such as cancer and diabetes with complications, and less for those in robust health. Lawmakers also hoped to cut Medicare waste and billing abuse that can occur when doctors and hospitals are paid for each and every thing they do, a practice known as “fee for service.”That can give them a financial incentive to do more to earn more.

Medicare adjusts the risk scores used in the Medicare Advantage program based on more than 70 conditions and their severity. That can mean thousands of extra dollars over the course of a year to treat a single patient.

Take depression. Mild and temporary feelings of sadness and hopelessness don’t increase Medicare payments. But if that depression and other symptoms linger for at least two weeks it may be classified as “major depressive disorder” and generate hundreds of dollars in payments to the Medicare Advantage plan to treat that patient.

Patients never know how their health is rated because neither the health plan nor Medicare shares risk scores with them -- and the process itself is so arcane and secretive that it remains unfathomable to many health professionals.

Health plans that cheat can face civil or criminal penalties, but federal officials largely trust them to collect medical data for risk scores accurately for the millions of seniors they sign up.

CMS conducts periodic audits -- known as Risk Adjustment Data Validation, or RADVs. But CMS has yet to impose major penalties when it detects inflated risk scores in those audits, though it may do so for the first time later this year. Still, CMS moves so sluggishly that if the past is a guide, at the rate they’ve been working it will likely take a decade or more to review hundreds of current Medicare Advantage contracts, records show.

CMS is but one part of the giant Health and Human Services Department. The HHS Office of Inspector General is supposed to backstop CMS and act as a watchdog to make sure that taxpayer dollars aren’t misspent. But CMS and the HHS OIG are in conflict over how best to conduct these audits. Neither would comment on the process.

Meanwhile, taxpayer losses pile up by the billions.

Based on its own sampling of data from health plans, CMS has estimated that faulty risk scores triggered nearly $70 billion in what officials deemed “improper” payments to Medicare Advantage plans from 2008 through 2013. Most were overcharges sparked by health plans “upcoding” -- overstating how sick their patients were&shy; -- or failing to document diseases they were paid to treat, according to CMS. Overall, Medicare paid the health plans about $135 billion in 2013.

But which health plans consistently have been overpaid -- and by how much -- remains under wraps. While CMS audits have detected billing errors in 30 percent or more of the patient files reviewed, the agency cloaks the identities of health plans audited and the results. CMS officials declined a Center for Public Integrity request to make its audits public or discuss the process. Last month the Center sued in an effort to obtain those audits.

Click here to read about the lawsuit.

The CMS policy means that the six audits by the HHS inspector general -- which does publish its findings -- stand as the only public account detailing Medicare Advantage billing practices over the past decade.

Those inspector general’s audits began late in 2008. Drafts weren’t presented to the health plans until two years later. The eye-popping findings didn’t begin to dribble out until 2012 -- even though Medicare paid the health plans hundreds of billions of dollars in the interim as enrollment began to surge.

Dr. Todd M. Husty, a Florida physician and medical billing consultant, said he was “shocked” that the HHS inspector general’s office failed to step up its audits given the early findings. “They could have cleaned this up four years ago,” he said. The health plans “were kind of sailing along not looking at how accurate their risk scores were because nobody ever dinged them.”

Patrick Burns, a co-director of Taxpayers Against Fraud, a Washington-based group, said that only stiff penalties will protect taxpayers from getting fleeced.

“The billing system has failed and needs to be rejiggered,” he said, adding, “Even when we catch it, nobody gets spanked.”

HHS Inspector General’s Office spokesman Donald White wouldn’t comment on the audits except to say that the office “stands by” its findings.

White conceded that further risk-scoring audits are “indefinitely on hold” because of the expense of paying medical coders to scrutinize patient files. Late last year, the office told Congress it would need to cut back on its workload to save money.

That decision leaves CMS as the only government entity watching over Medicare Advantage billing, and its findings are not made public.

The industry denies that the health plans overbill and notes that it has worked with federal officials to revamp recordkeeping practices.

“Medicare Advantage plans are working hard to comply with CMS requirements and we have every reason to believe these activities will be effective,” said Clare Krusing, director of communications of America’s Health Insurance Plans, the industry trade group.

Click here to see how risk scores changed.

Padded Bills

Under the traditional Medicare program, launched in 1966, the government pays doctors and other medical professionals according to the fee-for-service concept.

Congress first carved out a significant role for private health plans in Medicare in the 1980s.

Lawmakers decided Medicare would pay plans a monthly rate for each person they enrolled. They expected that would save money by curbing waste and unnecessary medical care that can occur in fee-for-service Medicare. Congress also reasoned that removing the incentive to overbill would help control fraud. Many lawmakers also favored a medical insurance option for seniors run by the private sector.

In 2003, Congress tried to boost the program’s fortunes by renaming it Medicare Advantage and phasing in risk-based payments to the private plans, starting in 2004. The expectation was that health plans wouldn’t shy away from taking sicker patients so long as they were paid fairly.

Medicare tried to predict the costs of treating a range of diseases, including those likely to require expensive treatment and adjusted payments upward for them. However, government officials paid little attention to warnings from some researchers that the strategy would spawn a whole new form of costly billing abuse that could prove immensely difficult to stamp out, government records reveal.

Quite simply: as Medicare began paying more for “sicker” patients, Medicare Advantage health plans began reporting their patients were sicker than the Medicare population as a whole.

Risk scores rose twice as fast for people who joined a Medicare health plan as for those who didn’t. A July 2004 CMS study of nine plans found inflated risk scores for a third or more of patients. A second study done for CMS opined that the upward trajectory could most logically be explained by Medicare Advantage plans chasing dollars, not by any decline in patients’ health.

In February 2008, CMS officials amplified that point, writing that it was not “reasonable to assume” that people in Medicare Advantage got sicker faster than seniors who chose standard Medicare coverage.

Since then, dozens of academic papers and government reports have probed the rising costs of the Medicare Advantage option. Some cite lax government oversight of risk scores, including persistent “upcoding,” as the main culprit.

The Center for Public Integrity’s analysis of Medicare Advantage billing data from 2007 through 2011 confirmed that risk scores rose more than twice as fast as the government-estimated average for people in standard Medicare in some plans in at least 1,000 counties nationwide.

CMS, starting in 2010, cut risk scores across the board, reducing payment rates to Medicare Advantage. But critics argue that even as the health insurance industry launches an intense lobbying campaign to shelve sharper rate cuts, it remains overpaid.

“That’s a systematic problem that has to be addressed,” said Dr. Robert Berenson, a former member of a panel that advises Congress on Medicare spending. He added that the method of payment leaves “a lot of room for bad actors.”

Click here to read the first part of the Center’s Medicare Advantage investigation.


Image: Cigna Corp. in in Philadelphia Matt Rourke / AP file

Pedestrians walk past the headquarters of the health insurer Cigna Corp. in in Philadelphia.

Industry Pushback

While HHS inspector general auditors sat on their findings for years, the industry was pushing back hard behind the scenes, trying to discredit the findings or keep them hidden, records show.

Excellus, a Rochester, New York based health plan attacked the auditors’ methodology in a December 2010 letter to an Inspector General’s Office official.

The health plan said the auditors’ finding that it was overpaid by about $41.6 million in 2007 was “inflated and based on flawed data.” The plan also blamed any deficiencies in record keeping on its doctors. An Excellus spokesman told the Center for Public Integrity that the health plan settled the matter in December 2013 by paying the government $157,777. “[The government] recognizes this is an industry-wide issue,” said the Excellus statement, “and it is adjusting its audit approach accordingly, while continuing to encourage health plans to work with the provider community to improve documentation of claims and diagnoses.”

PacifiCare, a division of insurance titan UnitedHealth Group, the nation’s largest Medicare Advantage contractor, hotly disputed audit findings for its plans in California and Texas.

Auditors had deemed the risk scores for 45 of 100 California patients “invalid” because medical records didn’t verify they had been treated for the conditions claimed. One patient who had knee replacement surgery was listed as having blood poisoning. While the medical chart confirmed the operation, no care for blood poisoning was evident.

United Health Group fired back in a September 2010 letter that HHS had “exceeded its authority.” In a second letter that year, the company criticized the audit methods. It demanded that the results be kept confidential while executives contested the audit finding that the plans could owe the government more than $539 million for 2007.

In the end, the inspector general’s review of six plans estimated that Medicare overpaid a total of nearly $650 million just for 2007, the only year studied. The inspector general lacked the power to demand refunds, but it recommended that CMS work out how much the health plans should return to the federal treasury. The inspector general did not pursue a broader investigation into the high error rates -- and still hasn’t. And CMS sided with the industry and ignored the inspector general’s recommendations.

A note on the Center's methodology.

Rules ‘Flawed’

The health plans contend that the audit process can be subjective and unwieldy because they must scramble to track down records of medical visits years after they occurred. Sometimes, doctors retire or move, making it hard to locate patient files, they say.

Several pointed out that they shouldn’t be penalized when doctors fail to keep adequate records. They also argued that no billing formula can fully predict who will require expensive medical care and they can lose money when risk-based payments don’t cover their costs.

Cigna Healthcare of Arizona, for example, disputed the audit finding that it was overpaid by more than $23 million for 2007. Calling the audit standards “fatally flawed,” CIGNA said it actually lost about $800,000 that year treating the 100 patients whose files auditors sampled.

The industry also argues that just because medical auditors can’t find a record of a disease doesn’t mean patients don’t have it, or that the condition isn’t affecting their health and treatment plan. Doctors are trained to detail what they did during an office visit, but may not dwell on all the underlying medical conditions that impact treatment decisions, they say.

HHS auditors counter that they can only rely on the medical record presented to them. If that record fails to substantiate a specific diagnosis and treatment, then they count it as an overpayment and want a refund. Under their contracts with the government, health plans are responsible for assuring these records are accurate.

James Cosgrove, who directs the health care division of the Government Accountability Office, the watchdog arm of Congress, said that federal health officials have yet to answer a basic question: did the health plan fail to provide the service or did it simply not document it properly?

“That’s something we would be very interested in looking at,” Cosgrove said.

Sympathetic ear

While the industry clashed with the Inspector General’s Office, it found a sympathetic ear at CMS. Rather than hammer the health plans for chronic billing blunders, the agency has mostly shrugged them off or settled for recouping minimal sums.

In February 2012, CMS officials decided to forgive overpayments to Medicare health plans made from 2008 to 2010. The surprise decision brought cheers to corporate boardrooms, according to John Gorman, a former federal health official who now advises Medicare Advantage plans.

Gorman said CMS decided that “the sins of the past are absolved.”

“They didn’t have to do that, and we, hundreds of CFOs and bankers up and down Wall Street and Madison Avenue, are thankful they did,” Gorman added.

The CMS decision certainly spelled relief for Coventry Health Care in Bethesda, Maryland, which operates in more than a dozen states and is owned by insurance giant Aetna. Within a week of the decision, the company freed up $133 million it had held in reserves to cover any potential liability from flawed risk scoring, according to its financial statements.

Humana Inc., which disclosed to securities regulators that it was the subject of six CMS payment audits for 2007, declined to say how much the audits cost the company, but noted the results were not significant financially.

CMS ignored the HHS inspector general’s finding that the six health plans it audited had been overpaid by an estimated $650 million for 2007. CMS settled five of the six audits for a total repayment of just over $1.3 million, the Center for Public Integrity confirmed.

Further, CMS decided not to chase after overcharges from 2008 through 2010 even though the agency estimated through sampling that it made more than $32 billion in “improper” payments to Medicare Advantage plans over those three years. CMS did not explain its reasoning.

CMS took that stance just a month after congressional auditors criticized the agency for failing to crack down on Medicare Advantage plans that overbilled.

CMS officials also decided in 2012 to conduct only 30 of its own confidential RADV overpayment audits each year. That’s less than a third of the number the agency said it would do in 2009. At that time, the Obama administration had promised to ramp up efforts to recoup overpayments to help fund the Affordable Care Act.

At that rate, it would take CMS more than 15 years to review the hundreds of Medicare Advantage contracts now in force.

CMS also helped out the industry in other ways likely to limit recoveries. The agency agreed to write off a portion of overpayments to account for doctors’ coding differences and mistakes, a concession insiders said was a big break for the health plans.

CMS officials also declared an amnesty period for voluntarily disclosing improper risk scores for which plans had been overpaid, much like a library suspending fines for a short period for the return of overdue books.

Trusiak, the former federal prosecutor, said CMS officials yielded too much ground to the industry and that these concessions will “restrict the amount of money recouped” by taxpayers.

Still, it’s not clear that the health plans will continue to slip the hook.

After years of delays and deliberation, CMS now intends to “extrapolate” its RADV audit findings for the first time later this year. Auditors will presume that the percentage of billing errors they find in a sampling of 200 patients exists throughout a plan’s full membership. That could potentially cost a large health plan millions of dollars or more.

Former CMS official Thomas E. Hutchinson, who helped design the RADV audit process and now advises health plans, said that small penalties weren’t taken seriously by the industry. In some cases, he said, it cost health plans more to retrieve medical records to buttress their billing than accepting the small CMS penalty for failing to do so.

Now, he said, health plans could face a “nuclear option” if they can’t justify their billings. “We either have too little a stick or too big a stick,” Hutchinson said.

CMS officials have said they expect to recover $370 million in overpayments as a result of their 30 audits that start this year. Though that’s significantly below earlier predictions, it still caught the industry’s attention.

Both Humana and UnitedHealth Group, the nation’s two biggest Medicare Advantage plans, have told investors they could be ordered to cough up significant refunds, according to Securities and Exchange Commission filings. Humana reported to the SEC in November that “certain” of its contracts would be audited. It offered no details. Other plans also warned investors of a “material effect” on their finances, the SEC filings show.

In January, CMS threw another curve by proposing regulations that would require health plans to return overpayments they had received dating back six years. CMS did not explain how that proposal was consistent with its earlier decision to forgive overpayments from some past years..

The regulations also clear the way for other divisions of HHS -- presumably the Inspector General’s Office -- to conduct more Medicare Advantage audits.

Whether the office will actually take up the challenge is anyone’s guess. It has already gone on record saying it lacks the funding to undertake comprehensive risk score audits, which it has set as a priority every year since 2008. In a video presentation outlining their investigative priorities for 2014, OIG officials made no mention of Medicare Advantage.

The inspector general’s audits are far more threatening to the industry than those done by CMS. The inspector general’s audits are widely distributed and can draw media attention as well as demands for reform in Congress.

Absent the inspector general’s review, it’s doubtful the public will ever get a full accounting of how accurately individual Medicare Advantage plans spend billions of tax dollars.

Burns, of the taxpayer rights group, said federal officials need to get serious about protecting tax dollars and keep from being “outgamed” by the health care industry.

“You need an electric fence for these cows,” he said. “As soon as you touch it you get nailed.”

The Center for Public Integrity is a nonprofit, nonpartisan investigative news organization in Washington, D.C.

    Billions in Medicare Advantage Overcharges Probably Gone Forever

    First published June 4th 2014, 6:02 pm

    Fred Schulte, Center for Public Integrity

      Schulte has received the George Polk Award, two Investigative Reporters and Editors awards, three Gerald... Expand Bio

      Wednesday, June 11, 2014

      Nexstim Initiates Multicenter Clinical Trial on the Therapeutic Effects of Navigated TMS for Stroke Rehabilitation

      Nexstim Initiates Multicenter Clinical Trial on the Therapeutic Effects of Navigated TMS for Stroke Rehabilitation

      June 11, 2014

      ALPHARETTA, Ga. — Nexstim has launched a multicenter double-blinded, randomized, and sham-controlled trial to determine the therapeutic effects of navigated rTMS (repetitive transcranial magnetic stimulation) for stroke rehabilitation. This cutting-edge stroke therapy combines occupational therapy with nTMS (navigated transcranial magnetic stimulation). Called the NICHE trial (Navigated Inhibitory rTMS in Contralesional Hemisphere Evaluation), this two year study will be conducted at twelve of the top rehabilitation sites in the United States.

      “The trial results are showing great potential for non-invasive brain modulation and the difference Nexstim is providing is the proven Navigation to enable this approach.” - Janne Huhtala, CEO, Nexstim

      Dr. Richard Harvey, Medical Director, Center for Stroke Rehabilitation, Rehabilitation Institute of Chicago (RIC), developed the protocol with Nexstim and ran the single center trial. Dr. Harvey and his team at RIC presented the trial results at the American Heart Association’s International Stroke Conference in February, The Contrastim Stroke Study: Improving Hand and Arm Function After Stroke with Combined Non-Invasive Brain Stimulation and Task-Oriented Therapy’ (presentation #152).

      Dr. Harvey’s study approached stroke rehabilitation through a new combination of therapies which produced significantly greater gains in patients’ motor function 6 months post stroke. The combination of non-invasive navigated transcranial magnetic stimulation (nTMS) along with occupational therapy opened the door to improving the quality of life for stroke survivors. The study showed over 80% of the active group received a clinically meaningful response rate.

      Researchers working at the following trial sites, will enroll up to 200 patients, and will look to replicate the initial findings.


      Mayo Clinic


      Ranchos Los Amigos National Rehabilitation Institute


      Shepherd Center


      Rehabilitation Institute of Chicago


      Indiana University


      Spaulding Rehabilitation Hospital

      New York

      Columbia University

      Burke Rehabilitation Center

      North Carolina

      Duke University


      Ohio State University

      University of Cincinnati


      TIRR Memorial Hermann Hospital

      About the Technology:

      The NBS System uses stereotactic MRI-guided transcranial magnetic stimulation (TMS) to non-invasively modulate precise areas of the motor cortex. The system’s e-field based targeting tool allows the therapist to accurately locate the patients exact stimulation target using technology similar to mapping the globe with a GPS. The nTMS is used to stimulate the patient’s non-injured brain hemisphere at a low frequency. This results in down-regulation of the excitability of the healthy side and restoration of the balance between the lesioned and healthy sides, allowing the lesioned side to regain function. Adding navigation to TMS is the key to finding the exact location and orientation of the e-field of the motor area that should be inhibited by stimulation. The stimulation is then accurately repeated in every session, assuring the dose is applied to the correct place.

      About Nexstim:

      Founded in 2000, Nexstim is committed to improving the quality of life of patients with significant unmet clinical needs. The advanced technology providing navigation to TMS has led to Nexstim being the world leader in image-guided transcranial magnetic stimulation (TMS). Nexstim has pioneered the technology for brain diagnostics and with FDA-clearance of the Navigated Brain Stimulation (NBS) System for non-invasive pre-surgical mapping. NBS is recognized as the emerging standard for pre-operative direct functional mapping. Nexstim’s NBS System enables treatment of brain injury and disease using rTMS with accurate and repeatable 3D-guidance of therapeutic electrical field.

      Nexstim’s non-invasive Navigated Brain Stimulation System is not approved by the Food and Drug Administration for therapy in commercial use in the United States and is available to select physician for investigational use only.

      High-Dose TMS May Rapidly Reduce Suicidal Thoughts

      High-Dose TMS May Rapidly Reduce Suicidal Thoughts

      Deborah Brauser

      June 10, 2014

      Repetitive high-dose transcranial magnetic stimulation (rTMS) is safe and rapidly decreases suicidal thoughts, new research suggests.

      A randomized study of 41 inpatients in suicidal crisis showed that those who received high-dose rTMS to the left prefrontal cortex 3 times daily for 3 consecutive days showed lower and more rapidly declining scores on the Beck Scale for Suicide Ideation (SSI) than those who received sham rTMS. This effect was even stronger after the first day, with the active treatment group showing a greater than 50% decrease in SSI scores.

      In addition, there were no between-group differences in treatment-related adverse events, and none of the participants had died of suicide at the 6-month follow-up point.

      "We found that this type of intense schedule of treatment was quite feasible and works well in an inpatient group," lead author Mark S. George, MD, psychiatrist and neurologist at the Medical University of South Carolina in Charleston and a staff physician at the Ralph H. Johnson VA Medical Center, told Medscape Medical News.

      "Because of the study's design, we didn't know if it would also give a hint as to whether [rTMS] would be effective for suicidal thoughts. But in fact we found just that ― and on the first day," said Dr. George.

      The study was published in the May issue of Brain Stimulation.

      Grim Statistics

      The investigators note that because suicide has become such a major public health concern, there is a strong need for new treatments.


      Dr. Mark George

      "The lack of a treatment hinders health care's ability to reverse stigma and educate the public," they write. "Further studies are needed to determine whether, with further refinement, study, and development, TMS ultimately may be a novel method to rapidly reduce suicidal thinking."

      According to the researchers, suicide is the number 2 leading cause of death in young adults in the United States, with someone dying by suicide every 13 minutes. It has hit the military particularly hard ― data from the past several years have shown that more soldiers have died by their own hands than in combat.

      "Eighteen US veterans die each day by suicide," note the investigators. "Despite these grim statistics, clinicians have no truly effective treatment for acute suicidal crisis."

      However, the US Food and Drug Administration (FDA) has approved a regimen of 4 to 6 weeks of repeated daily rTMS to the left prefrontal area for treatment-resistant depression. And some past open-label studies have shown rapid reductions in suicidal thoughts after treatment with rTMS.

      Although most patients in suicidal crisis "are not routinely psychotic, there is clear evidence that the governing prefrontal cortex is unable to do its job of regulating emotional drive, put problems in context, and plan for the future," the researchers explain.

      For this study, they sought to assess whether a high dose of rTMS was feasible, safe, and effective for suicidal inpatients.

      "We wondered if we could give higher doses in shorter amounts of time and get people better quicker," said Dr. George. "There's never really been an aggressive dosing or safety study looking at this."

      A total of 41 adult inpatients (mean age, 42.5 years) who had been admitted to 1 of 2 military hospital wards because they were deemed to be in suicidal crisis were enrolled and were told they would be receiving 9 sessions of treatment. They were then randomly assigned to receive 3 30-minute sessions daily for 3 consecutive days of either active (n = 20) or sham rTMS (n = 21).

      The active rTMS group had the treatment "delivered to the left prefrontal cortex with a figure-eight solid core coil at 120% motor threshold" for a total of 54,000 total stimuli at the end of the 9 sessions, report the researchers.

      "Sham rTMS used a similar coil that contained a metal insert blocking the magnetic field and utilized electrode on the scalp, which delivered a matched somatosensory sensation," they add.

      The primary outcome measures were daily changes in severity of suicidal thinking on the SSI and subjective visual analogue scale (VAS) assessments made before and after each session. The active treatment group had a mean total SSI score of 21.7 at baseline vs 20.8 for the sham treatment group.

      Secondary outcome measures included score changes on the Hamilton Rating Scale for Depression (HRSD), the Montgomery-Åsberg Depression Rating Scale (MADRS), and the Columbia Suicide Severity Rating Scale (C-SSRS).

      Rapid Effect

      All participants (85% men, 71% white) had comorbid posttraumatic stress disorder and/or mild traumatic brain injury because this study was part of the INjury and TRaUmatic STress (INTRUST) Consortium, funded by the Department of Defense.

      They continued to receive their prescribed antisuicidal treatments, including medication and/or counseling, in addition to their active or sham rTMS treatment.

      "These patients were so critically ill that we couldn't not give them their other treatment as usual," noted Dr. George.

      Results showed that the overall retention rate for all participants at the end of the 3-day intense schedule of treatment was 88%.

      Although mean SSI score decreases at the end of the 3 days were similar between the active and sham rTMS groups (-15.6 points and -15.3 points, respectively), there was a more rapid decline on the first day with the active group (-10.7 points vs -6.4 points, respectively).

      "This decline was more pronounced in the completers subgroup," report the investigators. In other words, there was a 13-point decrease in the active treatment completers (n = 9) vs a 5.9 point decrease in the sham treatment completers (n = 14, P = .05).

      In addition, the "being bothered by thoughts of suicide" VAS ratings were less, albeit nonsignificantly, for the full active treatment group vs the full sham treatment group after the 9 sessions (-42.5 points vs -31.9 points, respectively).

      But just as with the SSI scores, the differences were more significant between the completers subgroups (active group, -43.8 points; sham group, -24.9 points; P = .03).

      "The suggestions of a rapid anti-suicide effect (day 1 SSI data, VAS data over the 3 days) need to be tested for replication in a larger sample," write the investigators.

      Surprising, Promising

      There were no serious adverse events (AEs) reported, and no significant between-group differences in nonserious AEs.

      The most common AE reported was headache, which was reported by 5 of the active treatment participants and by 4 of the sham treatment participants. In addition, diplopia, brain contusion, back pain, dizziness, and erythema at the coil stimulation area were each cited by at least 1 active treatment participant.

      Nausea, vomiting, and dizziness were cited by at least 2 of the sham treatment participants, and eye pain, blurred vision, myokymia, migraine, and hypertension were cited by at least 1 of the sham treatment participants.

      There were no significant between-group differences in length of initial hospital stay (mean time, 10 days). Seven of the active treatment group members and 4 of the sham treatment members were readmitted for psychiatric reasons during the 6-month follow-up period, but there were no completed suicides by any of the participants.

      There were also no differences between the groups in follow-up scores on the SSI, HRSD, MADRS, or C-SSRS.

      "This pilot study demonstrates that it is feasible and safe to administer a very large dose…of prefrontal rTS" to this patient population, write the investigators.

      "Nine treatments in 3 days were reasonably well-tolerated without major side effects, even in this severely ill cohort that is rarely studied due to their severity of illness," they add.

      Dr. George said the effectiveness results were somewhat surprising and very promising.

      "There were some patients who were readmitted. We never expected just 3 days of treatment to be a cure, although it can knock down the symptoms. But what's important is that no one went on to successful suicide," he said.

      "We're not at the point where this a recommended treatment yet, but it has clinical implications," he added. Such implications include the fact that more than 1 treatment can be safely administered in a single day to patients with severe depression.

      However, for those in suicidal crisis, "we really need to do a follow-up study before we can say anything definitive about treatment," said Dr. George.

      The study authors have reported no relevant financial relationships.

      Brain Stimul. 2014;7:421-431. Abstract

      Medscape Medical News © 2014  WebMD, LLC

      Send comments and news tips to

      Cite this article: High-Dose TMS May Rapidly Reduce Suicidal Thoughts. Medscape. Jun 10, 2014.

      Saturday, June 7, 2014

      Vagal nerve stimulation without dissecting the carotid sheath during intraoperative neuromonitoring of the recurrent laryngeal nerve in thyroid surgery.

      Head Neck. 2013 Oct;35(10):1443-7. doi: 10.1002/hed.23154. Epub 2012 Sep 18.

      Vagal nerve stimulation without dissecting the carotid sheath during intraoperative neuromonitoring of the recurrent laryngeal nerve in thyroid surgery.

      Wu CW1, Dionigi G, Chen HC, Chen HY, Lee KW, Lu IC, Chang PY, Hsiao PJ, Ho KY, Chiang FY.

      Author information
      • 1Faculty of Medicine and Institute of Clinical Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Otolaryngology-Head and Neck Surgery, Kaohsiung Medical University Hospital and Kaohsiung Municipal Hsiao-Kang Hospital, Taiwan.

      Vagal nerve stimulation (VNS) has been recommended as a routine procedure during intraoperative neuromonitoring (IONM) of the recurrent laryngeal nerve (RLN). However, many surgeons have been discouraged from performing VNS because of the need for opening the carotid sheath. The purpose of this study was to investigate the feasibility and reliability of VNS without carotid sheath dissection.


      Two hundred twenty patients with 376 nerves at risk were enrolled in this study. VNS without nerve exposure during IONM was applied by simply pressing a ball-tip stimulator on the space between the carotid artery and jugular vein.


      VNS without nerve exposure was feasible in all cases and did not result in any morbidity. All VNS signals were successfully obtained within 30 minutes of the start of the operation and all showed a clear and reliable laryngeal electromyography (EMG) response that was similar to that from the conventional method in which nerve exposure for VNS is applied.


      VNS without dissecting the carotid sheath is feasible and reliable, rendering it a simple, safe, and surgeon-friendly procedure during IONM.

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      Wednesday, June 4, 2014

      Cyberonics' (CYBX) CEO Dan Moore on Q4 2014 Results - Earnings Call Transcript

      “Depression and TRD, in the fourth quarter, we estimate the 24 generators when planted for TRD, highest numbers since the second of quarter fiscal 2009. We believe that many of these implants were replacement generators for Medicare patients. We are encouraged to see patients with TRD, continuing with VNS Therapy when the battery is depleted and also to see CMS providing coverage for some replacement treatment.” --- Dan Moore, CEO