FDA allows marketing of magnetic stimulator for migraine with aura

14 December 2013 by Markus Dahlem, posted in Uncategorized

“It's like something you'd see on Star Trek”. That's how it was described five years ago in this video: therapeutic magnetic stimulation in migraine. This technique is investigated for much longer. Now, yesterday, the FDA allowed marketing of the first transcranial magnetic stimulator for migraine with aura. And only for migraine with aura, as I understand it—I will get back to this point.

The decision is based on a new study published in “Headache” that concludes: “Two decades of clinical experience with sTMS [single pulse transcranial magnetic stimulation] have shown it to be a low risk technique with promise in the diagnosis, monitoring, and treatment of neurological and psychiatric disease in adults.”

I'm interested in transcranial magnetic stimulation (TMS) ever since the late Edward Chronicle got an award from the Dr Hadwen Trust, a UK-based non-animal medical research charity. Ed wanted his research to concentrate on human volunteers, rather than using animals. For him, TMS could help to study patients who suffer from migraine. Of course, he also embraced my noninvasive (unless math itself gives you a headache) computational studies immediately and we published a paper “A computational perspective on migraine aura” together in 2005.

Electrical and magnetic stimulation is even older, going back to Scribonius Largus, court physician to the Roman emperor Claudius 47 AD, who used the black torpedo fish (electric rays) to treat migraine headaches.

neuromodulationTNG

I have no estimate how much money was on Scribonius Largus payroll due to his innovative clinical practice. But before I continue, I should probably indicate my own potential Conflict of Interest: I received once honoraria for consulting services at Neuralieve Inc. (trading as eNeura Therapeutics), the company that manufactures the Cerena TMS device. I heard the name Cerena now for the first time in the FDA news release, to me it is know as the Spring TMS Total Migraine System, but it is probably the same device. Anyway, my honoraria was just enough to pay my flight and hotel in the US. But even in a blog post, this should be mentioned.

 Why only migraine with aura?

“The study did not evaluate the device’s performance when treating types of headaches other than migraine headaches preceded by an aura.”

This can be read in the FDA News Release.

That is a pity, I think, for at least two reasons. Migraine aura is far more complex than most basic clinicians appreciate. On our website Migraine Aura Foundation, we list more than 50 different transient migraine aura symptoms. So I am not at all sure whether everybody who has an aura is actually diagnosed as a patient suffering from migraine with aura.

The second reason, maybe even more important reason, is that there is a concept called silent aura. While it remains disputed whether or not a clinically silent migraine aura exists, such silent courses are supported by both a well-documented case report and my computational studies.

The case report shows that blood-flow changes exist that are likely related to the neuronal correlate of the aura without actually causing the symptoms in this case.

In a recent paper, I develop the concept of a migraine generator network in the brain. Within this network, we can identify the most promising targets for electrical and magnetic stimulation devices and the optimal timing of stimulation protocols. The concept of silent aura is important in this context, as it relates to Dynamical Network Biomarkers. In particular, the computational studies suggest that headache in migraine without aura and migraine with aura are likely to share the same pain mechanism.

At this time, only migraineurs that suffer form migraine with aura can fly on the enterprise.

 


3 Responses to “FDA allows marketing of magnetic stimulator for migraine with aura”

  1. Annie Reply | Permalink

    I too am disappointed that this treatment has not been tested/approved for migraine without aura. I've had migraines all my life - I always know when I'm going to get one, but don't know if I get what's clinically understood as an 'aura' - and I am curious th know how much of a difference it really makes in the efficacy of treatment. Is the lack of approval just because it hasn't been tested on that group (however it's defined), or because it has and hasn't proven effective?

    • Markus Dahlem Reply | Permalink

      In one study were about 200 people that suffered from migraine with aura. But I am sure that in due course of further technical development, we will see more studies also with people meeting the other diagnostic criteria.

  2. Edward Fruitman Reply | Permalink

    Basically, the magnetic stimulation techniques for medical and psychological treatment are very sensitive matter in which minor mistakes can cause serious problems in future life. That's why some strict procedures for distribution of magnetic stimulators should be taken.

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