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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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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