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.
Are you eager to get your hands on a transcranial magnetic stimulator to treat migraine? The Spring TMS, which received FDA approval last May, won’t be available to patients until the completion of a post-approval study to determine how to use the Spring TMS most effectively. And the study can’t be completed until more participants are recruited. You can try the Spring TMS for free and help bring it closer to availability to others by participating in the study.