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Update on Transcranial Magnetic Stimulation Device Availability

Cerena, the transcranial magnetic stimulation device that the FDA approved in December, is a prototype that will not be made commercially available. Instead, eNeura Therapeutics, the company that created the Cerena, is working on a smaller, more portable, and easier-to-use device, which they anticipate manufacturing later this year. Having the Cerena’s approval in hand is expected to speed up the FDA’s approval of the new device.

Once the new device has been manufactured, it will be tested in a pilot study at six headache clinics in the U.S. The goal of the pilot study is to determine the optimal use of the device for treating migraine. About 600 patients are expected to participate. Unfortunately, I can’t tell you how to become a patient tester because I don’t know exactly which clinics will be part of the pilot study.

The researcher organizing the pilot study, who happens to be my headache specialist, is hopeful that the study will begin in May or June of this year and that the device will be commercially available in January 2015. I would love for that to be the case, but January 2016 seems more likely.

Sorry I don’t have better news for those of you who are eager to try TMS. I’ve been waiting for it for so long that another year or two doesn’t seem like an eternity, but I’m also not currently desperate for relief.

(I’m not naming the researcher because I received this information in a private appointment, not in an interview. While the information is not confidential, attributing something my headache specialist said during an appointment seems like a breach of boundaries.)

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FDA Approves Transcranial Magnetic Stimulation Device for Migraine

Exciting news! The FDA announced yesterday that transcranial magnetic stimulation (TMS) has received their approval for marketing. After at least eight years of the news media touting TMS as a promising non-invasive migraine treatment, many patients have been eagerly awaiting this announcement. The approved device, called Cerena, should be available to patients soon, but the details on availability, cost, and eligibility are unclear.

The FDA announcement says the Cerena is specifically for use in people with migraine with aura. Most migraineurs will read that as a visual aura, but the FDA describes aura as “a visual, sensory or motor disturbance immediately preceding the onset of a migraine attack.” So, even if you don’t think of yourself as having migraine with aura, if you have sensory or motor disturbances prior to the onset of pain, you may fit the definition.

The designation of the Cerena as a treatment for migraine with aura is likely because the particular study that was used for approval included only participants who met that definition. While much of the research on TMS has focused on patients who have migraine with aura, it still has potential for those who have migraine without aura. Whatever your migraine type, you can probably still get the device, but insurance companies may only cover it for people who have migraine with aura.

The study that prompted the FDA’s approval included 201 patients whose migraines were preceded by aura in at least 30% of their attacks. Of those, 113 said they used the Cerena to treat a migraine when pain was present. 38% who used it when they had migraine pain were pain-free two hours after using the device (compared to 17% who did not use it) and 34% of users were pain-free 24 hours after using it (compared to 10% in the group that didn’t use it).

While TMS was effective in treating the pain for some participants, it did not reduce associated symptoms, like nausea and sensitivity to light and sound. I wonder if it would relieve other, less-recognized symptoms, like the fatigue and brain fog that kick my butt during a migraine. Dizziness was the most commonly reported adverse affect.

Whatever the details turn out to be, this is an exciting development in migraine treatment. My headache specialist has already recommended it to me, so I’ll definitely be asking him for the scoop when I see him next month. I’ll let you know what I learn.

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News, News, News

There is never enough time for me to post about all that I want to write about. And there’s been a ton of headache news lately. Here are some highlights.

Detailed Results of Trexima Studies (the drug isn’t named in the study, but it looks like Trexima to me)

  • Neck pain and discomfort decreased significantly at two hours for the compound versus placebo in study 1 (35 and 44 percent) and study 2 (28 and 54 percent).
  • Sinus pain and pressure decreased significantly at two hours for the compound versus placebo in study 1 (19 and 33 percent) and study 2 (23 and 38 percent).(1)
  • More patients were pain free at two hours in both studies (52 and 51 percent) compared to placebo (17 and 15 percent) and sustained pain-free response was maintained for significantly more patients (45 and 40 percent), without the use of a rescue medication, to 24 hours, compared to placebo (12 and 14 percent).
  • The compound was effective in rapidly eliminating migraine pain, as measured by pain-free rates at 30 minutes, one hour, two hours and four hours.
  • Incidence of migraine associated symptoms (nausea, phonophobia (sensitivity to sound) and photophobia (sensitivity to light)) was lower with the compound than with placebo.
  • The compound was generally well-tolerated. In both studies, only nausea (3 and 4 percent) and dizziness (1 and 2 percent) were reported in at least 2 percent of patients who took the compound versus placebo (1 and 2 percent for nausea, 0 and < 1 percent for dizziness).

Confusion Over Safety Of NSAIDs For Pain Relief Leads Patients To Suffer In Silence
Almost two thirds of people surveyed (64%) said they were confused about what to take for pain relief because of conflicting information on drug safety that has emerged following the withdrawal of Vioxx (rofecoxib), a COX-2 selective non-steroidal anti-inflammatory drug (NSAID) . Around 4 out of 5 (78%) said they didn’t know enough about the risks and benefits of medicines, whether prescribed or bought over-the-counter. Almost half (47%) said they weren’t using any painkiller medication at all for a number of reasons. Some were concerned about side effects, often after reading worrying news stories about painkillers, some had been advised to stop medication by their PCP and some thought they could manage without them.

Triple Therapy Synergy for Frequent Severe Migraine (registration may be required to read this)
The combination of behavioral migraine management, preventive medication, and optimal acute therapy appears to provide a superior reduction in migraine activity measures, functioning, and quality of life compared with any one alone, according to a study presented at the American Headache Society meeting here.

For these patients, “effective migraine management may require three components: a tailored acute therapy, preventive medication and behavioral migraine management to get the optimal results,” said Kenneth Holroyd, Ph.D., a professor of health psychology at Ohio University in Athens, Ohio, in an oral presentation.

Overweight Kids More Likely to Get Headaches
Children with headaches are 36 percent more likely to be overweight, results of the new research suggest.

“The numbers tell us that being overweight may contribute to kids having more headaches, most often migraines,” said Andrew D. Hershey, M.D., Ph.D., director of the Headache Center and a pediatric neurologist at Cincinnati Children’s Hospital Medical Center. “There likely are a number of causes, including poorer general health, body stress, lack of exercise and nutrition. It may not be that being overweight directly causes migraine, but that the reasons for being overweight cause these children to have worsening headaches.”

Magnetic Device Short-Circuits Migraine Headaches, Suggests Early Research
A hairdryer-sized magnetic device held briefly to the back of the head may short-circuit migraines before the pain starts, suggests preliminary research being presented at the 48th Annual Scientific Meeting of the American Headache Society (AHS).

People With Near-Daily Migraine Headaches Get Relief From Anti-Seizure Drug
An anti-seizure medication “quiets the brain,” providing relief to people with near-daily migraine headaches, suggest results of a randomized, multi-center study being presented at the 48th Annual Scientific Meeting of the American Headache Society (AHS).

FDA OKs the Pain Drug Opana
The drug, called Opana, is an opioid pain reliever taken by mouth. It will come in an extended-release form, called Opana ER, and an immediate-release version, simply called Opana.

The drugs contain oxymorphone hydrochloride, which was previously only available by injection. Endo Pharmaceuticals plans to relaunch the drug’s injected version for hospital use under the new trade name.

If you know of an article that I missed, please add it to the comments. Thanks!

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A Possible Technology to Abort Migraines

Ohio State University researchers are investigating the use of a transcranial magnetic stimulator to abort migraines. Sufferers hold the device, which looks like a hair dryer, to their heads at the first warning of an impending migraine. It creates a magnetic field that will interrupt the electrical stimulation in the brain that occurs in the brain before a migraine and triggers aura. At least that’s what researchers hope will happen.

TMS is a brain mapping tool. NIH describes it as:

“…a new tool for the study of the human brain and for neurological therapeutics. A pulsed current in a coil produces a magnetic field that generates, in turn, an electric field that activates nearby excitable neural elements. When used over the motor cortex, TMS produces a motor-evoked potential in the muscles innervated by the corticospinal tract, allowing central motor conduction time to be measured. TMS can transiently excite or inhibit neural activity, and probe regional brain excitability and intracortical circuits. Repeated use of TMS with rapid trains of stimuli can produce long-lasting therapeutic effects in the treatment of depression, Parkinson’s disease, and pain states.”

It appears the research is in the super-early stages, so that’s all I’ve learned so far. It sounds much more appealing than an implant.

via Click on Detroit