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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.

2 Responses to FDA Approves Transcranial Magnetic Stimulation Device for Migraine

  1. Timothy Bauer says:

    Thanks Kerrie:

    I have been following this device for 4 years. Contacted the
    company yesterday and here was received back from company.
    __________________________________________________________

    Hi Timothy -

    Thank you for your inquiry. We just received FDA clearance on Friday, 13DEC, and have not yet launched the product in the U.S.A. When it is available, it will be through prescription only. We will send more information as soon as it becomes available.

    Best regards,

    -Leslie

    Leslie Fitzgerald
    Customer Care Manager

  2. Lisa says:

    It still feels a long way off to the day I might get to try this thing, but I am happy to hear it’s at least been approved!!

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