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Thursday, December 26, 2013

“What results can I expect?”

What an absolutely great question and topic for discussion. “What results can I expect?” (posted December 26, 2013)

By the way and to Cyberonics website administrator you’ve listed a “dead link”. Try clicking on the link you’ve posted.

I’d like to share my views from the perspective of a very, very long-time support person to my spouse Joyce. Only my thoughts are shared from the standpoint of VNS Therapy for the depression patient as I am more knowledgeable as opposed to the issues of the epilepsy patient. Although, there are many points I address which are similar such as the VNS Therapy.

Knowing that which I do from my experiences, readings, research, knowledge and collaborations with both patients and medical professionals for half-century there still is no way of knowing in advance what therapy will or will not illicit a potentially favorable response and efficacy in the depression patient. Worse yet there is also no way of knowing which patient may or may not encounter potentially serious side-effects from any given therapy.

Some 50 years ago I coined a phrase which I still feel is applicable today, “The Trial and Error Approach to Wellness.”

After some 36 years of MDD (Major Depressive Disorder) Joyce was right back in another depressive episode and wanting to die to which I add that she had some 9 unsuccessful suicide attempts notched in her medical history. We were desperate. We had exhausted the pharmacopeia of drugs, holistic approaches, ECT etc. and had come off 9 months of mega-dosing of a relative new anti-depressant drug (Effexor XR) at the time which worked and then raised once again the refractory issue.

In our desperation I researched and found out about the initial trial for VNS Therapy for depression. Thanks to the Epilepsy community, Cyberonics initial early message forum on their website and collaboration with one young woman benefiting from VNS Therapy for her epilepsy, we embarked upon the unknown adventure of VNS Therapy for depression some 14 years ago.

In Joyce’s case the results of the therapy for depression has been nothing short of truly remarkable. We no longer discuss depression which at one time consumed every waking moment of our lives for more than 3 decades. In Joyce’s case she is also no longer on any anti-depressant medications.

While Joyce has benefited we are fully aware and cognizant of others who have not and worse yet some who have encountered additional serious side-effects. This is not to preclude the therapy is ineffective. It simply is no different than the many experiences we all have shared in common with numerous other therapies which may initially work and then peter-out or cause us to experience serious side-effects.

Whether epilepsy or depression patient we have shared many experience in common. For those of us who have benefited from the VNS Therapy and Joyce in particular, the VNS Therapy has worked like no other treatment in the 5 decades that she has battled her illness. There simply are no guarantees as to who will or will not respond to any given therapy and then maintain efficacy which brings us back to “The Trial and Error Approach to Wellness.”

With that said I can only advocate to the others who are challenged by their respective illnesses to continue their education and researching as I also encourage hope and persistence.



Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

Friday, December 20, 2013

Cerena TMS gets FDA Clearance for Migraine Treatment

Cerena TMS gets FDA Clearance for Migraine Treatment

Contract Manufacturing, Industry News, Design, Components, Devices

FDA allows marketing of the first device to relieve migraine headache pain.

December 19, 2013

The U.S. Food and Drug Administration has allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS), by eNeura Therapeutics, the first device to relieve pain caused by migraine headaches that are preceded by an aura: a visual, sensory or motor disturbance immediately preceding the onset of a migraine attack.

Migraine headaches are characterized by intense pulsing or throbbing pain in one area of the head accompanied by nausea and/or vomiting and sensitivity to light and sound. A migraine can last anywhere between 4 hours and 72 hours when untreated. These debilitating headaches affect approximately 10% of people worldwide and are three times more common in women than in men. About one third of people with migraines experience an aura.

“Millions of people suffer from migraines and this new device represents a new treatment option for some patients,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.

The Cerena TMS is a prescription device used after the onset of pain associated with migraine headaches preceded by an aura. Using both hands to hold the device against the back of the head, the user presses a button to release a pulse of magnetic energy to stimulate the occipital cortex in the brain, which may stop or lessen the pain associated with migraine headaches preceded by an aura.

The FDA reviewed the data for the Cerena TMS through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.

The FDA reviewed a randomized control clinical trial of 201 patients who had mostly moderate to strong migraine headaches and who had auras preceding at least 30% of their migraines. Of the study subjects, 113 recorded treating a migraine at least once when pain was present. Analysis of these 113 subjects was used to support marketing authorization of the Cerena TMS for the acute treatment of pain associated with migraine headache with aura.

The study showed that nearly 38% of subjects who used the Cerena TMS when they had migraine pain were pain-free two hours after using the device compared to about 17% of patients in the control group. After 24 hours, nearly 34% of the Cerena TMS users were pain-free compared to 10% in the control group.

The study did not show that the Cerena TMS is effective in relieving the associated symptoms of migraine, such as sensitivity to light, sensitivity to sound, and nausea. The device is for use in people 18 years of age and older. The study did not evaluate the device’s performance when treating types of headaches other than migraine headaches preceded by an aura.

Adverse events reported during the study were rare for both the device and the control groups but included single reports of sinusitis, aphasia (inability to speak or understand language) and vertigo (sensation of spinning). Dizziness may be associated with the use of the device.

Patients must not use the Cerena TMS device if they have metals in the head, neck, or upper body that are attracted by a magnet, or if they have an active implanted medical device such as a pacemaker or deep brain stimulator. The Cerena TMS device should not be used in patients with suspected or diagnosed epilepsy or a personal or family history of seizures. The recommended daily usage of the device is not to exceed one treatment in 24 hours.

Families turn grief to suicide prevention efforts

Families turn grief to suicide prevention efforts

Those who have lost loved ones, experts, urge awareness of depression over holidays

Dec. 18, 2013   | 

Mary Reeves, left, with her daughter Anna Steele, found help through the support group Survivors of Suicide following the death of her son, Trey. She now works to helps others.

Mary Reeves, left, with her daughter Anna Steele, found help through the support group Survivors of Suicide following the death of her son, Trey. She now works to helps others. / Heidi Heilbrunn/Staff

Written by
Liv Osby
Staff writer

The morning after the 2005 Super Bowl, Trey Reeves drove his father’s pickup truck to his parents’ place at Lake Keowee.

The month before had been tough for Reeves. Depressed over a break-up with his girlfriend, he was also suffering withdrawal from the anabolic steroids he’d been using to bulk up.

Worried, his mother, Mary Reeves, followed him from their home in Piedmont and raced inside to find her beloved son lying dead from a self-inflicted gunshot. He was 25.

“He had just shot himself when I got there,” Reeves told The Greenville News. “It is a life-altering event. You never get over it.”

Though suicide is a subject fraught with religious and moral implications that many people want to avoid, it happens more often than people think. And the numbers are on the rise, both locally and across the nation.

There were four suicides in Greenville County between Nov. 8 and Nov. 13 alone, according to Coroner Parks Evans.

And the holidays can be a particularly tough time of year, with higher rates of depression, according to Dr. Kenneth Rogers, chairman of the department of psychiatry at Greenville Health System.

But Reeves and other survivors of suicide say there is help to be found. There is hope.

And many have turned their grief into action by speaking out to end the stigma of suicide and offering a hand to those struggling with thoughts of ending their own lives.

On the rise

Every day in the United States, 105 people take their own lives, according to the American Association of Suicidology. And nearly 1 million make an attempt each year.

Suicide is the 10th leading cause of death in the nation — the third leading cause for young people, the group reports.

And suicide rates have been increasing nationally for the past several years, particularly among military veterans and young people, Rogers said.

South Carolina, with 637 suicides in 2010, ranked 28th nationally in the rate of suicide.

In Greenville County, there were twice as many suicides as homicides in 2011 — a trend that’s held for several years, Evans said. There were 34 homicides in 2011, but 75 suicides, he said. In 2000, there were 42 suicides.

Victims range from the very young to the very old, he said. Their deaths are sometimes linked to a domestic situation, or a murder-suicide, he said.

Often, the economy is implicated.

“These are people who haven’t had work for a long time and they can’t provide for themselves or their family any more,” Evans said. “Or they lost their house and are having to leave.”

Sometimes, the deaths seem more senseless than other suicides, he said, adding that he’s seen cases where adolescents have killed themselves over a bad grade.

Mental Health America of Greenville County runs CRISISline, a 24-hour suicide prevention hotline, and Survivors of Suicide, a support group for people who’ve lost loved ones to suicide.

Executive director Jennifer Piver said calls from suicidal residents are up 41 percent — or about 280 people — this year over 2012.

“In 2012, we had 18 individuals who had done something to kill themselves while talking to us — what we call in-progress suicide calls,” she said. “Up to this point this year, we’ve had 55.”

The agency also has seen a 38 percent increase this year in the number of clients seeking support after a loved one’s suicide, she said.

Piver attributes the increase to inadequate treatment options in the area, depression over long-term unemployment — a factor that’s been on the rise since the economy went sour in 2008 — and physical health issues like chronic pain.

Holidays critical

The holidays are a critical time of year, Rogers said, with higher rates of depression and suicidal thoughts.

“It’s important for families and friends to watch out for family members that may be at risk,” he said. “There are many cases where you may not have a clue, but the vast majority will usually tell someone close to them they are thinking about killing themselves.”

That needs to be taken seriously, he said.

Things to watch for include people who’ve experienced significant losses, those who are depressed, engaging in different patterns of behavior such as increased impulsivity, drinking and drug use, or someone who was the life of the party who doesn’t want to go out any more, Rogers said.

A Wren High School graduate, Trey Reeves stayed physically fit at the Citadel, his mother said. He loved sports, and after college, he worked as a co-host on WCCP 104.9 FM Talk Sports radio and coached basketball for 8-year-olds.

A regular at the gym, he was in great shape. But eventually, he began to take steroids to look more muscular, she said. He quit them about a year before his death, but that withdrawal changed him, she said. He missed a lot of work and complicated his life with drugs and alcohol, she said. And though he talked to his friends, he didn’t seek professional help.

“If you had asked him three months before he died, he would have told you he was the happiest guy in the world and had the best life,” she said. “But the worst thing we think he did ... was anabolic steroids. It was the withdrawal from them that did it. I think he just gave up.”

Major depression is the most common reason for suicide, followed by bipolar disorder and psychotic conditions like schizophrenia, Rogers said.

'A factory reject'

It was bipolar disorder that drove Traci Barr to attempt suicide.

As the eldest of three children, the Greenville woman grew up with loving parents who were able to provide her with everything she needed.

But even as a child, she said, she felt “like a factory reject.” And by the time she hit 14, she was depressed and had lost interest in friends, sports or anything she once enjoyed. Plagued by insomnia, she found school difficult. She thought about killing herself even then, she said.

Her family doctor diagnosed her with “manic depression,” now called bipolar disorder, and prescribed an antidepressant.

Somehow, Barr managed to get through high school and college. During the manic phases of her illness, where she was productive and organized, she’d find a job and begin to make a life with the help of a psychiatrist and medication. But the crash inevitably came, rendering her helplessly depressed for months at a time, struggling to get out of bed.

When a long-time relationship ended because of her illness, she began a downward spiral that ended with a nervous breakdown, hospitalization, electroconvulsive therapy and, about two years ago, a suicide attempt.

“The only thing I had in my life, I felt, to anchor me was taking care of my dog,” she said. “And in that time frame, my dog died, and I knew it was only a matter of time.”

In January 2012, she said, she took a massive dose of Xanax and Ambien.

“I’d written a letter to Mom and Dad, and my intent was to crawl into bed and just not wake up again,” she said. “Instead, I got behind the wheel ... and crashed my car into a ditch.”

At a local psychiatric hospital, Barr, now 50, finally found help that turned her life around. It included following a strict medication regimen, going to group therapy and other counseling, and accepting her condition.

“For me, it was a realization that I couldn’t keep fighting what was true about me, which was that I am a person with mental illness,” she said, “as much as I don’t want to be, as much as I have spent over 35 years trying not to be.”

Something that can be done

For coroners, dealing with suicides is especially hard, Evans said.

“It is tougher in cases such as this where you see so many things that could possibly have been done,” he said. “And it’s always a situation where loved ones want to know why this happened, why they did what they did. And a lot of times we cannot ever answer that.”

Evans said there must be something that can be done to raise awareness about suicide and reduce the numbers.

That’s what Lynn and Marion Terry want to do.

Their son, Bryan, committed suicide eight years ago after struggling with bipolar disorder for most of his life.

Though he kept searching for medications that would relieve his symptoms without leaving him feeling emotionally flat, or in some cases, even worse than the illness, he never found them, his mother, Lynn, said.

“After a while, he grew weary of trying,” she said. “He would think, ‘Nothing’s going to help. There is no hope for me.’ ”

At the age of 24, he called his parents to say good-bye, and took his own life.

Though devastated, it opened the Terrys’ eyes to the shocking number of suicides and put them on a path to learning more about mental illness, to work to end the stigma and advocate for more care.

Times have changed, they said, but not enough. Society still doesn’t understand how many people are affected, they said.

One in four adults, or about 61.5 million Americans, has a mental illness in a given year, NAMI reports, and one in 17, or about 13.6 million, has a serious mental illness like schizophrenia, major depression or bipolar disorder.

“More than 90 percent of those who die by suicide have one or more mental disorders,” said Ken Dority, executive director of NAMI Greenville.

“The more people talk about it,” Lynn Terry said, “the more people will realize how many people are affected.”

The Terrys want to see mental illness regarded like diabetes or any other condition, and given the same attention as cancer when it comes to research into treatments and cures.

Damaging stigma

Reeves, who runs a sewing machine and fabric business in Greenville, said no one thinks twice about treatment for a broken bone or cancer.

“It is an illness like any other,” she said.

Though many factors influence why people don’t get help, stigma is at the top of the list, Lynn Terry said.

Evans said that simply ruling a death a suicide can cause problems with survivors because of the stigma.

“The family’s very unhappy because of the stigma that goes with it,” he said.

And, he added, the survivors are victims, too.

Reeves said so many people were traumatized by her son’s suicide in addition to his family, including the children on the basketball team. His Citadel class even established a scholarship in his memory.

The cost of care and lack of insurance coverage for mental health treatment is another reason people don’t get help, which also contributes to the stigma, said MHAGC’s Piver.

Last month, the federal government issued final rules to enable the same coverage for mental health disorders as for physical conditions in group and individual insurance plans. The Affordable Care Act also requires mental health coverage for plans in the health care marketplace.

That coverage should help make treatment more affordable and accessible, and hopefully reduce the number of suicides, Rogers said.

But while there are providers who take insurance, there are also many who don’t, he said, and that can delay care.

According to new research from Weill Cornell Medical College, the number of psychiatrists nationwide who take private insurance declined 17 percent — to 55 percent — from 2005 to 2010. Those taking Medicare dropped nearly 20 percent, and only 43 percent took Medicaid — the lowest of all the specialties.

Such low rates may affect access to care, the researchers wrote, and if the trend continues, the impact may be more severe.

“For example, not only are there fewer physicians who can help people with moderate to severe symptoms of mental illness, those patients must then try to find a doctor who will take their insurance,” said Dr. Tara F. Bishop, an assistant professor in the school’s Department of Public Health and Medicine. “This is not a formula for success.”

A lack of services

And Greenville suffers from a shortage of psychiatrists and other providers, while state-funded mental health centers, which have seen budget cuts in recent years, are overburdened, experts say.

More than half of those with mental illness — children and adults — receive no mental health services, Dority said.

“Folks are just struggling because a lot of the centers had to narrow their focus to treat those who are very severely mentally ill, leaving a huge gap of folks who just aren’t able to get treated by mental health professionals,” Piver said.

But Rogers said it’s important for people to find a safe place to talk about their thoughts and feelings. While some may need professional care, others can benefit from a support group, like one run by NAMI or MHAGC, he said.

Dority said that along with offering support to those with mental illness and their families, groups like NAMI-Greenville and MHAGC work to raise awareness and educate the community.

The Terrys are members of NAMI, and Reeves found help at Survivors of Suicide. They all work to help others now.

“Helping is healing,” Reeves said. “We all learn and gain from each other.”

Barr, a healthy eating specialist who is now a member of NAMI’s board, said the group made a huge difference in her life. And what drives her most these days is helping others.

“There still needs to be so much work done in terms of awareness, and if (people) don’t understand it, they fear it, and possibly keep turning their backs on it,” she said.

“Two years ago, I was not capable of doing a load of laundry,” she continued. “I feel very strong now. It’s a miracle that I survived. That I didn’t die in the overdose or the car wreck. And now I feel optimistic. There’s real hope for us to overcome.”

Combination of Corpus Callosotomy and Vagus Nerve Stimulation in the Treatment of Refractory Epilepsy.

Eur Neurol. 2013 Dec 5;71(1-2):65-74. [Epub ahead of print]

Combination of Corpus Callosotomy and Vagus Nerve Stimulation in the Treatment of Refractory Epilepsy.

Guillamón E, Miró J, Gutiérrez A, Conde R, Falip M, Jaraba S, Plans G, Garcés M, Villanueva V.

Author information
  • Servicio de Neurología y Neurocirugía, Unidad Multidisciplinar de Epilepsia, Hospital Universitario y Politécnico La Fe, Valencia, Spain.

Background: Palliative techniques such as partial corpus callosotomy (CC) and vagus nerve stimulation (VNS) may be effective for adequate control of seizures in pharmacoresistant patients who are not candidates for resective surgery. Objective: The objective of this study was to analyze the efficacy of the combination of these two techniques in patients where the first surgery had not achieved adequate control. Materials and Methods: This is a retrospective review of 6 patients with refractory epilepsy in which both types of surgery were performed, CC and VNS. We analyzed variables such as age, sex, age at onset of epilepsy, seizure types, electroencephalogram and magnetic resonance imaging results, and number of pre- and postoperative seizures. Results: Three patients first underwent VNS and then CC, and 3 patients were treated in reverse order. All patients had some improvement after the first surgery, but they continued to experience persistent falls, so a second palliative technique was used. The mean improvement after both surgeries was 89% (90% in patients first receiving CC and 87% in patients who first underwent VNS). Conclusions: In adequately studied patients who are not optimal candidates for resective surgery, palliative surgery is a choice. The combination of VNS and CC shows good results in our series, although the right order to perform both procedures has not been defined. These results should be confirmed in a larger group of patients. © 2013 S. Karger AG, Basel.

[PubMed - as supplied by publisher]
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Evidence-based guideline update: vagus nerve stimulation for the treatment of epilepsy: report of the guideline development subcommittee of the american academy of neurology.

Epilepsy Curr. 2013 Nov;13(6):297-303. doi: 10.5698/1535-7597-13.6.297.

Evidence-based guideline update: vagus nerve stimulation for the treatment of epilepsy: report of the guideline development subcommittee of the american academy of neurology.

Morris GL 3rd1, Gloss D2, Buchhalter J3, Mack KJ4, Nickels K4, Harden C5.

Author information
  • 1Aurora Epilepsy Center, St. Luke's Medical Center, Milwaukee, WI.
  • 2Barrow Neurologic Institute, Phoenix, AZ.
  • 3University of Calgary, Alberta, Canada.
  • 4Mayo Clinic, Rochester, MN.
  • 5Hofstra University North Shore-Long Island Jewish Medical College, Great Neck, NY.

To evaluate the evidence since the 1999 assessment regarding efficacy and safety of vagus nerve stimulation (VNS) for epilepsy, currently approved as adjunctive therapy for partial-onset seizures in patients >12 years.


We reviewed the literature and identified relevant published studies. We classified these studies according to the American Academy of Neurology evidence-based methodology.


VNS is associated with a >50% seizure reduction in 55% (95% confidence interval [CI] 50%-59%) of 470 children with partial or generalized epilepsy (13 Class III studies). VNS is associated with a >50% seizure reduction in 55% (95% CI 46%-64%) of 113 patients with Lennox-Gastaut syndrome (LGS) (4 Class III studies). VNS is associated with an increase in ≥50% seizure frequency reduction rates of ~7% from 1 to 5 years postim-plantation (2 Class III studies). VNS is associated with a significant improvement in standard mood scales in 31 adults with epilepsy (2 Class III studies). Infection risk at the VNS implantation site in children is increased relative to that in adults (odds ratio 3.4, 95% CI 1.0-11.2). VNS is possibly effective for seizures (both partial and generalized) in children, for LGS-associated seizures, and for mood problems in adults with epilepsy. VNS may have improved efficacy over time.


VNS may be considered for seizures in children, for LGS-associated seizures, and for improving mood in adults with epilepsy (Level C). VNS may be considered to have improved efficacy over time (Level C). Children should be carefully monitored for site infection after VNS implantation. Neurology® 2013;81:1-7.

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Monday, December 16, 2013

Nerve stimulation therapy helps Duluth woman regain life

Nerve stimulation therapy helps Duluth woman regain life

Brette Garnatz, 28, had outpatient surgery in 2009 and again last year for placement of a device that brought her frequent epileptic seizures and debilitating side effects from medications to an end.

By: John Lundy, Duluth News Tribune


  • Brette Granatz


    Brette Granatz of Duluth sits with her dog, Koda. Granatz has epilepsy, but a vagus nerve stimulator implanted in her chest has kept her seizure-free for more than four years. (Clint Austin /

  • Vagus nerve stimulator


    Brette Granatz of Duluth holds a vagus nerve stimulator. She wears a medic alert braclet and a magnet to activate a VNS that’s implanted in her chest in case of an epileptic seizure. (Clint Austin /

  • How vagus nerve stimulation therapy works


    How vagus nerve stimulation therapy works

  • Aiding with seizures


    Aiding with seizures


Sometimes, Brette Garnatz tells people the scars on her neck were caused by a cougar attack.

“And some people believe it,” the 28-year-old Lakeside resident said with a grin.

In fact, the narrow scars were caused not by an animal but by a surgeon’s knife. Garnatz had outpatient surgery in 2009 and again last year for placement of a device that brought her frequent epileptic seizures and debilitating side effects from medications to an end.

Married to a teacher and about to begin nursing school at Lake Superior College, Garnatz is one of about 50 million people worldwide with epilepsy, a brain disease characterized by recurrent seizures.

But she is somewhat unusual in a couple of respects.

The risk of seizures is greatest between the ages of 1 and 20 and then increases after the age of 60, said Dr. Richard Kanoff, a child neurologist at Essentia Health who specializes in treating epilepsy in patients of all ages.

But Garnatz, who grew up in Menomonie, Wis., went through the first 20 years of her life without a hint of a seizure.

Also, the therapy that helps stabilize Garnatz’s nervous system, vagus nerve stimulation (VNS), has been used in a relatively small number of epilepsy patients. More than 70,000 patients have had the stimulation device implanted since it was approved in Europe in 1994 and in the United States in 1997, according to its manufacturer, Houston-based Cyberonics.

Moreover, it’s not always as effective as it has been in Garnatz’s case.

“Somewhere around 10-15 percent of patients may become seizure-free with VNS,” said Kanoff, Garnatz’s neurologist since she and her husband, Drew Garnatz, moved to Duluth in 2009.

Garnatz hasn’t had a seizure since October 2009, nine months after the device was implanted.

“I am very, very fortunate,” she said.

‘So confused’

Fortune didn’t seem to be on Garnatz’s side when she started having seizures three years earlier. Then a junior studying community health education at the University of Wisconsin-La Crosse, she drove to school on a route that crossed the Mississippi River.

One day, though, she never made it to school. She found herself at a gas station with no idea how she had gotten there.

“I stopped, and I got out and called family that was close by and just stayed until I felt OK,” Garnatz said.

She wrote it off as being overly tired.

But a couple of weeks later, she called her mother after a class. Realizing something was wrong, her mother told her to meet her aunt — who worked at the school — by the university’s landmark clock tower.

“I don’t remember any of this,” Garnatz said. “I just remember being so confused, and not knowing what was going on.”

After a battery of tests, Garnatz was diagnosed with epilepsy.

‘Out of the blue’

The disease can be triggered by events, such as an injury or a stroke, Kanoff said. But it’s not unusual to have seizures with no identifiable cause.

That appeared to be the case with Garnatz. She played soccer when she was young, but she never suffered a head injury, she said.

“Brette is someone who started having seizures essentially out of the blue,” Kanoff said.

Garnatz was given a variety of medications, in various dosages and combinations, with no success. She was having seizures several times a week.

She was taking as many as seven drugs, and they were extracting their own toll.

“All of the medications made me very, very lethargic,” she said. “It was hard to go to class, hard to get out of bed, and my memory was just terrible.”

In the fall of 2007, Garnatz went to Mayo Clinic in Rochester, Minn., for further testing. Under the direction of the team at Mayo, Garnatz continued to try different combinations of medicines in 2008. She also was placed on a ketogenic diet, a high-fat, low-carbohydrate diet most often tried with young children.

Nothing helped.

Raising the threshold

“And they said, ‘OK, it’s time,’ ” Garnatz said. “ ‘Let’s bring up the topic of the vagus nerve stimulator.’ ”

The vagus nerve exits the brain and travels down the neck to the rest of the body, Kanoff explained. The stimulator, about the size of a small watch, essentially is a pacemaker for the brain. It’s normally planted in the patient’s left chest, and a wire is connected from it to the left vagus nerve.

The stimulator emits intermittent electrical impulses that travel up the vagus nerve to the brain, Kanoff said. The effect, at least in some patients, is that seizures are reduced or eliminated.

“The idea is, you raise what we call the ‘seizure threshold,’ ” Kanoff said. “That’s the brain’s own ability to prevent seizures. … People with epilepsy have a reduced seizure threshold. … But what VNS does is provide a rhythmical current to the brain that raises the seizure threshold.”

Garnatz knew that if the new treatment had any effect, it wouldn’t be immediate. Various settings were tried over time. The default setting, Kanoff said, is on for 30 seconds and off for five minutes. Eventually, Garnatz’s doctors settled on 20 seconds on and two minutes off, with a higher-than-standard frequency.

Support in Duluth

Meanwhile, the Garnatzes moved to Duluth in June 2009 after being married in May at the church camp where they met. They made sure to find a place on a bus route, because Brette wasn’t allowed to drive. She was delighted to learn that a neurologist who knew how to care for patients with VNS was available, and a surgeon was available when the device has to be replaced, as it did last year.

She was glad to discover an active chapter of the Epilepsy Foundation in Duluth, and she quickly became involved. She’s on the foundation’s board for Northeastern Minnesota, and she’s one of organization’s top volunteers, said Mary Giese, the group’s outreach coordinator.

“I didn’t have a support group when I was in La Crosse,” Garnatz said. “You can have family and friends, but it’s so important to have someone else who has it.”

One of the people Garnatz met was a young boy with epilepsy and autism. The boy had a VNS implant.

Giese was watching as the two got together for the first time.

“She immediately got down to his level and showed him the scar that she has on her neck,” Giese said. “And she touched his chest where the implant was and had him touch her chest where the implant was. His eyes got big. … He caught on right away.”

Although seizure-free for four years, Garnatz still keeps with her a magnet that can be placed over the implant to jump-start it in the event she feels she may be starting to have a seizure. The magnet also can be held in place to keep the VNS from triggering. That’s to counter the device’s one side effect — a hoarse-sounding throat when it’s on. She used it, for example, while singing alto in the Duluth Superior Symphony Orchestra Chorus.

She’s driving again and excited about studying to be a nurse. It’s a career she was inspired to take up because of the care she received from Mayo Clinic nurses, she said.

Although she realizes it doesn’t work for everyone, Garnatz attributes vagus nerve stimulation therapy for a vast improvement in her quality of life.

“One of the biggest things for me is I’m no longer a walking zombie,” she said. “It brings life back; it gives you energy. My memory is so much clearer. It’s amazing how much better it has been.”

Saturday, December 14, 2013

Deep brain stimulation provides relief other treatments can't


Deep brain stimulation provides relief other treatments can't

December 14, 2013 10:13 PM

By Mark Roth / Pittsburgh Post-Gazette

For Melanie, it was a matter of millimeters.

That was the difference between feeling only slightly better, to knowing that she could start her life over again and emerge from 14 years of debilitating depression that included suicide attempts, months of hospitalization, every medication under the sun and more than 40 electroshock therapy sessions.

Melanie, a 37-year-old from Toronto, is one of the more than 200 people with depression to receive deep brain stimulation, or DBS, in which twin holes are drilled in the skull and two electrodes are guided to an area deep in the brain to stimulate it with pulses of electricity.

Unlike almost every other patient, though, Melanie, who asked that her last name not be used, has had the procedure done twice -- and that created a critical difference.

When her first procedure was carried out at Emory University in Atlanta in October 2009 by a team led by DBS pioneer Helen Mayberg, it provided her some relief, particularly more normal sleep patterns. But she said when Dr. Mayberg evaluated her, "she knew something was changing, but it was not as pronounced as anyone had hoped."

Over more than 20 years of work with this technology, Dr. Mayberg said in a recent interview, she has identified what she thinks is a critical spot to which to guide the electrodes. It is in a deep brain structure known as the sugenual cingulate, or Area 25, which is overactive in many people with chronic depression.

The electrical impulses seem to quiet that area, but it is also important that they be able to stimulate bundles of nerve fibers running to other parts of the brain, and when she examined Melanie's brain scans, she found that her electrodes were not in the ideal position.

She suggested Melanie undergo another DBS surgery, in July 2010. Melanie was willing, but she went into the second operation thinking it probably wouldn't help. "I appreciated them wanting to try, but I had sort of resigned myself that this was as good as it was going to get."

In the second surgery, she was kept partially awake so doctors could gauge her reaction to the current being turned on. When they first did that, "I wasn't feeling anything when they asked me questions, and I think I started having this impending feeling of, 'Here we go again,' and then all of a sudden I felt myself take a really deep breath and there was this sense of something lifting away.

"I always felt like there was noise in my head yelling all the time, and it just got quiet for a second. I felt my brain relax, and then I noticed how many people were in the operating room, and I felt I could see clearly, where before everything had sort of been a fog all the time."

She really knew what a difference it had made, though, when they turned the current off temporarily so they could complete the surgery, which involves snaking the wires from the electrodes beneath the scalp and down to twin stimulator packs beneath the clavicles.

When the electricity stopped, she said, "I felt bad. It was as though it all came rushing back like a crushing grip."

While DBS is still experimental, there have been enough cases that researchers already have coalesced into two large groups in their philosophical approach.

One group, led by Dr. Mayberg, thinks that the pessimistic moods and thoughts of major depression should be the primary target of DBS. Area 25, which seems to control those feelings, is the area she focuses on.

"This area activates with negative mood. It's at a junction point that connects to many regions that are implicated in depression," she said. "What you're trying to do is turn negative mood and psychic pain off, and to me, all the other symptoms of depression are connected with that."

Other DBS psychiatrists are more concerned with patients who cannot get any sense of enjoyment in their lives, and they have aimed the electrodes at spots like the nucleus accumbens, a brain area associated with rewards and pleasure.

The University of Pittsburgh participated in early trials of DBS for depression, but is not doing such work now, officials said.

The big test will be trials underway now to compare DBS and a sham version of the procedure in the same kind of patients. In the sham version, the electrodes are implanted but not turned on. The U.S. Food and Drug Administration is likely to approve DBS for widespread use only if it shows substantial improvement over the placebo therapy.

Melanie had first considered DBS several years ago, but her family had been too afraid of her getting brain surgery.

Eventually, though, she was so desperate that she moved to Atlanta for six months with her brother's help so she could get the treatment.

She was frightened, but not because of the surgery itself.

"The scary part is that every time you try something new, you tell yourself there's a possibility you can get better, and hope is a very dangerous thing to have, because it never worked. After you sign up for brain surgery, there's probably not much left for you to try after that."

Now that the DBS is working properly, Melanie said, she can start to undo the bad habits she had developed after 14 years of just trying to survive.

To get through each day during that long emotional winter, she had stopped trying to develop relationships with people, and would go hours without speaking to anyone.

Now, with the DBS creating a new normal, she is working hard to engage with life again.

"I'm not easy to live with now, and I'm not perfect, and I still have a lot of work to do, but DBS is in some ways a miracle for me, and I feel like I've been given a second chance."

FDA Approves First Device to Treat Migraine Pain

FDA Approves First Device to Treat Migraine Pain

Susan Jeffrey

December 13, 2013

The US Food and Drug Administration (FDA) today allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS; eNeura Therapeutics), the first device approved to relieve pain caused by migraine headache with aura.

"Millions of people suffer from migraines, and this new device represents a new treatment option for some patients," Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in a statement.

The device is used by prescription after onset of pain associated with migraine with aura. Using both hands, the patient holds the device to the back of the head and, pressing a button, releases a pulse of magnetic energy that stimulates the occipital cortex, stopping or reducing the pain associated with this type of migraine.

"The FDA reviewed the data for the Cerena TMS through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device," the FDA statement notes.

They reviewed data from a randomized control clinical trial including 201 patients with mostly moderate to severe migraine headaches with auras preceding at least 30% of episodes. Of these patients, 113 recorded treating a migraine at least once when pain was present, and the analysis of these 113 patients was used to support the marketing authorization, the release said.

Results showed that nearly 38% of patients using the TMS device were pain-free 2 hours after using the device vs 17% of control patients. After 24 hours, nearly 34% of treated patients were pain-free vs 10% of the control group.

However, treatment was not associated with relief of other associated symptoms of migraine, including sensitivity to light or sound and nausea, the FDA adds. The device is for use in patients 18 years of age or older, and the study did not evaluate performance of the device in other types of headaches.

Adverse events reported with treatment were rare in both device and control groups, the FDA release said, but included single reports of sinusitis, aphasia, and vertigo. "Dizziness may be associated with the use of the device," the agency adds.

The device should not be used in patients who have metals in the head, neck, or upper body; who have an implanted medical device such as a deep brain stimulator or pacemaker; or those who have suspected or diagnosed epilepsy or a personal or family history of seizures, the FDA statement said.

"The recommended daily usage of the device is not to exceed 1 treatment in 24 hours," it concludes.

Wednesday, December 11, 2013

Cyberonics Announces Results From The E-36 Study Of VNS Therapy® Delivered By The AspireSR™ Generator

PR Newswire

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Cyberonics Announces Results From The E-36 Study Of VNS Therapy® Delivered By The AspireSR™ Generator

Investigators present results at the American Epilepsy Society (AES) meeting in Washington, DC

HOUSTON, Dec. 8, 2013 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ: CYBX) announced today that results from the E-36 clinical study of the AspireSR generator were presented at the annual AES Meeting, taking place December 6-10 at the Walter E. Washington Convention Center in Washington, D.C.  

Paul Boon, M.D., Ph.D., Senior Full Professor of Neurology and Director of Ghent Institute for Neuroscience at Ghent University presented results of the study entitled, "Vagus Nerve Stimulation Triggered by Cardiac-Based Seizure Detection, A Prospective Multicenter Study," on December 7, 2013.  The study (NCT01325623) was designed to evaluate the performance and safety of the AspireSR generator and its IntelliSense™ cardiac-based seizure detection feature.

Prof. Boon and clinical research colleagues at 13 other European centers implanted a total of 31 patients with the investigational AspireSR generator, which provides "normal mode" VNS Therapy augmented by seizure response stimulation.  After the implant procedure and initial stimulation adjustment period, patients were admitted to an epilepsy monitoring unit for up to five days and monitored to identify seizures and collect heart-rate data. 

The study met its primary endpoint in that the AspireSR generator, with IntelliSense cardiac-based seizure detection, detected more than 80% of seizures accompanied by ictal tachycardia (heart-rate increase) at a range of programmable settings.  The potential false detection rates were low.  The detections occurred close, and in some cases prior, to seizure onset, which may improve the effectiveness of the therapy.  In a clinical study evaluating 9,482 seizures, augmentation of VNS Therapy with manually-activated acute stimulation at seizure onset terminated 24% of seizures and diminished the severity or duration of another 38% of seizures1.  The recently published evidence-based guideline update by the American Academy of Neurology on the use of VNS Therapy in epilepsy includes a recommendation that acute stimulation may be associated with seizure termination when used at the time of seizure auras2. The safety profile for the AspireSR generator is consistent with currently available VNS Therapy systems. 

"The E-36 study demonstrated the accuracy of the cardiac-based seizure detection algorithm for seizures with heart rate changes," said Prof. Boon.  "Triggering stimulation when a seizure is detected should benefit patients with refractory epilepsy given the evidence that on-demand stimulation using the magnet can acutely interfere with seizure activity."

"The AspireSR product represents an important milestone in Cyberonics' ongoing commitment to provide technologically-advanced device-based solutions for people with epilepsy.  We believe the addition of the proprietary IntelliSense seizure-response feature will continue to advance VNS Therapy as a foundational therapy for patients with refractory epilepsy," said Dan Moore, President and CEO of Cyberonics.

1 Morris GL, et al. Epilepsy Behav 2003;(4):740-5

2 Morris GL, et al. Neurology 2013;DOI 10.1212/WNL.0b013e3182a393dl 

About Cyberonics, Inc. and VNS Therapy®
Cyberonics, Inc. is a medical technology company with core expertise in neuromodulation.  The company developed and markets the VNS Therapy System, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression.  The VNS Therapy System uses an implanted medical device that delivers pulsed electrical signals to the vagus nerve.  Cyberonics offers the VNS Therapy System in selected markets worldwide.

Additional information on Cyberonics and the VNS Therapy System is available at

Safe harbor statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended.  These statements can be identified by the use of forward-looking terminology, including "may," "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or other similar words.  Statements contained in this press release are based on information presently available to us and assumptions that we believe to be reasonable.  We are not assuming any duty to update this information if those facts change or if we no longer believe the assumptions to be reasonable. Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning achieving an improved therapeutic effect from the AspireSR generator, obtaining regulatory approval and commercial release of the AspireSR generator, and advancing VNS Therapy as a foundational therapy for patients with refractory epilepsy.  Our actual results may differ materially.  Important factors that may cause actual results to differ include, but are not limited to: continued market acceptance of VNS Therapy™ and sales of our products; the development and satisfactory completion of clinical studies and the regulatory approval of new products, including a VNS Therapy System for the treatment of other indications; satisfactory completion of the post-market registry required by the U.S. Food and Drug Administration as a condition of approval for the treatment-resistant depression indication; adverse changes in coverage or reimbursement amounts by third-parties; intellectual property protection and potential infringement claims; maintaining compliance with government regulations and obtaining necessary government approvals for new products and indications; product liability lawsuits and other litigation; reliance on single suppliers and manufacturers for certain components; the accuracy of management's estimates of future revenue and expenses; the potential identification of material weaknesses in our internal controls over financial reporting; and other risks detailed from time to time in our filings with the Securities and Exchange Commission (SEC).  For a detailed discussion of these and other cautionary statements, please refer to our most recent filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended April 26, 2013 and our Quarterly Report on Form 10-Q for fiscal quarters ended July 26, 2013 and October 25, 2013.

Contact Information

Greg Browne, CFO
Cyberonics, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
Main:  (281) 228-7262
Fax:  (281) 218-9332

SOURCE Cyberonics, Inc.


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“Unwanted stepchildren of Cyberonics”

To the VNS Facebook Site Administrator for Cyberonics,

I think the AES Annual Meeting 2013 and the photos from this convention are outstanding and a means of conveying the good this and other organizations do for the epilepsy patient population.

I still ask as a spouse of one of the “Unwanted stepchildren of Cyberonics”, the depression patients, why is there no mention and/or promotion relating to the depression patients? Why is there no coverage of the annual DBSA (Depression Bipolar Support Alliance) conventions or that of The Brain and Behavior Research Foundation or NAMI? Worse yet is your total denial of the existence of depression patients using the FDA approved VNS Therapy?

Isn’t it obvious to you folks that your lack of concern, acknowledgement or response is repugnant to many of the patients who utilize your device and therapy for depression and to their support persons as well who read this forum?

Isn’t it time you folks came out of the closet and admit you have others with just as serious an illness?



Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733