Tag: FDA

News & Research, Treatment

SpringTMS Transcranial Magnetic Stimulation for Migraine Gets FDA Approval

Kerrie Smyres

SpringTMS, the first transcranial magnetic stimulation device for migraine that will be available to patients, has received FDA approval. Details are still sparse, but I’ve written up what I can find in SpringTMS Transcranial Magnetic Stimulation Device for Migraine Receives FDA Approval on Migraine.com. The highlights:

  • Approval was based on a study of people with episodic migraine with aura. Participants had to have a visual, sensory or motor aura preceding at least 30% of their attacks and have between one and eight attacks a month. This may not be the final target population, though, depending on who is included in the pilot study and what the findings are.
  • Before becoming available to the general public, several headache centers in the U.S. will conduct a pilot study to determine the optimal way to use the device. These clinics have yet to be made public. I’m looking into how to become part of the study and will let you know what I find.
  • The cost is unknown. In England, it cost £160 per month (about $270 USD), as of January 2014.
  • It will probably eventually be covered by insurance, but those details are unknown.
  • It will be prescription-only.
  • SpringTMS is a smaller version of Cerena, which received FDA approval in December 2013. Cerena will not be available to patients.

Here’s what I learned about the pilot study after I saw my headache specialist, who is organizing the study, in January: Update on Transcranial Magnetic Stimulation Device Availability. It looks like it could be on track for general availability in January 2015.

News & Research, Treatment

FDA Approves Cefaly for Migraine Prevention

Kerrie Smyres
Cefaly
(i can’t believe I’m posting a selfie with a Cefaly.)

The FDA has approved the Cefaly for migraine prevention in the U.S., according to an announcement from the agency yesterday. Purchasing details aren’t available yet, but it shouldn’t be too long since it is already being manufactured for other countries. It will be available by prescription, which I expect means it will also be covered by insurance. You can order one now at Cefaly.us. The device itself is $295 and a pack of three electrodes costs $25. You must send them your prescription before they will ship your order. I don’t know what this means for eventual insurance coverage.

Here’s an excerpt from the FDA’s press release that describes the studies the approval was based on:

The agency evaluated the safety and effectiveness of the device based on data from a clinical study conducted in Belgium involving 67 individuals who experienced more than two migraine headache attacks a month and who had not taken any medications to prevent migraines for three months prior to using Cefaly, as well as a patient satisfaction study of 2,313 Cefaly users in France and Belgium.

The 67-person study showed that those who used Cefaly experienced significantly fewer days with migraines per month and used less migraine attack medication than those who used a placebo device. The device did not completely prevent migraines and did not reduce the intensity of migraines that did occur.

The patient satisfaction study showed that a little more than 53 percent of patients were satisfied with Cefaly treatment and willing to buy the device for continued use. The most commonly reported complaints were dislike of the feeling and not wanting to continue using the device, sleepiness during the treatment session, and headache after the treatment session.

Neither of these studies are new and still have the limitation of being short-term, but I’ll reiterate that it’s worth trying out. Even more so now that you won’t have the additional expense of ordering it from Canada and your insurance may pay for it. I’ll keep you posted on it’s availability.

Here’s my experience with it, including a detailed description of what it feels like:

Chronic Migraine, News & Research, Treatment

A (Small) Step Closer to a TMS Device for U.S. Migraineurs

Kerrie Smyres

eNeura, the company that made the Cerena transcranial magnetic stimulation (TMS) device, has taken one more step toward making TMS available to U.S. patients by completing a filing requirement with the FDA.

Woo hoo! A company did some paperwork. What’s the big deal?

With this filing, eNeura has officially told the FDA that a new device (called SpringTMS), based on the recently approved Cerena, is in the works. In other words, SpringTMS is not only happening, but the company has started moving toward FDA approval.

Still wondering why I’m telling you this? In a press release, eNeura’s president says that the company is “optimistic that the SpringTMS will launch in 2014.” Now, “launch” is pretty vague. It could mean that the device will be available to patients in 2014. It could also mean that the final FDA approval process will get underway. Or maybe that the pilot study will begin. Whatever the president truly meant, my fingers are crossed that my cynical prediction of availability to patients in January 2016 is overly negative.

For many of you, this bit of news doesn’t mean anything at all. For those who are desperately awaiting the availability of a TMS device in the U.S., even a little step forward is progress.

News & Research, Treatment

Update on Transcranial Magnetic Stimulation Device Availability

Kerrie Smyres

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.)

News & Research, Treatment

FDA Approves Transcranial Magnetic Stimulation Device for Migraine

Kerrie Smyres

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.