[News] Headband for migraine prevention

Nakamova

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For those of you suffering migraines in addition to your seizures:

The Food and Drug Administration on Tuesday said it had approved the first medical device to prevent migraine headaches. The device, made by a Belgian company, Cefaly Technology, is small, portable and battery powered, and it looks like a plastic headband. It is worn across the forehead and over the ears, and contains a small electrode that applies an electric current to stimulate the nerve that is associated with migraine headaches. A study of 67 people in Belgium found that those who used the device reported significantly fewer days with migraines per month than those who used a placebo.
Here's the website for the device, for folks who want to learn more or read testimonials:
http://www.cefaly.com/en/
 

epileric

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I'm always suspicious of consumer goods that depend too much on testimonials.

I've read up on cefaly and there is minimal proof that they do anything.

Also, Remember that the FDA can approve anything as long as it is safe, whether or not it works.

A respected neurologist did a write up on cefaly but I'll quote just the conclusion for those who just want to get to the point.
Conclusion

The Cefaly device is based upon a treatment paradigm in which electrical stimulation is used to modulate neurological function, specifically to reduce pain or reduce the triggering of painful syndromes, like migraines.

I do think these types of treatments, some of which are fairly well established, are plausible and have promise. However, that is like saying that drug therapy is plausible and well established. We still need specific controlled clinical trials of specific electrical stimulation treatments in specific conditions before we can make any reliable treatment claims.

The one controlled clinical study of Cefaly in migraine is not convincing, with borderline statistical results. I am not sure why the FDA approved the device on this evidence alone. I am also not sure if it’s a good idea. The company now has little incentive to do further clinical research.

For myself, as a clinician with specialization in migraine, I may consider using the device. Again, it has the virtue of safety and plausibility. But I consider the device still experimental and will use it as such. I also hope to see some academic clinical studies to provide further evidence as to its efficacy.
Those who want to read the whole review can do so here: Electrical Nerve Stimulation for Migraine
 
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epileric

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Here is another review on the headband by someone with a BSc in biology & an MSc in pharmacology.

The important thing to note here is that Cefaly has been approved through the “de novo premarket review pathway, a regulatory pathway for generally low- to moderate-risk medical devices”. The safety study referenced by STX-Med for approval involved over 2,000 patients of which only 4.3% reported any adverse reactions, all of which were mild and reversible following discontinuation of treatment. This study did not examine the effectiveness of the headset in any way other than a vague outcome of ‘patient satisfaction’.

The study that did involve efficacy had only 67 patients in the trial, but some of the outcomes showed promise. The researchers compared sham neurostimulation against the standard Cefaly stimulation. There was no control without a device.

The STS generates biphasic rectangular impulses with an electrical mean equal to zero and the following characteristics: pulse width 30 µs for sham and 250 µs for verum, frequency 1 Hz for sham and 60 Hz for verum, maximum intensity 1 mA for sham and 16 mA for verum. The daily sham or verum neurostimulation sessions lasted 20 minutes.
Patients maintained a diary and recorded headache frequency and severity.

Primary outcome measures were 1) change in monthly migraine days between the run-in month and the third month of treatment; and 2) percentage of “responders,” i.e., of subjects having at least 50% reduction of monthly migraine days between run-in and third month of treatment.

Secondary outcome measures were 1) change in monthly migraine days between run-in and the average 3 months of treatment; 2) change in monthly migraine attack frequency; 3) change in monthly frequency of any headache; 4) change in mean headache severity per migraine day; 5) change in monthly acute antimigraine drug use and in associated symptoms per migraine headache between run-in and third month of treatment; and 6) percentage of patients stating at the end of the trial that they are very satisfied, moderately satisfied, or not satisfied with the treatment.
My statistics are rusty, but the number of total comparisons would increase the possibility of a false positive, and the inclusion of study dropouts using data up to the time they left the study seems questionable to me. Perhaps someone with a grasp of the relevant stats could leave a comment to help clarify the appropriateness of the analysis.

There were a number of reasons that patients were excluded from the study:

Exclusion criteria were use of a preventive antimigraine treatment in the previous 3 months, failure on well-conducted preventive drug treatments, medication overuse headache (ICHD-II 8.2), frequent/chronic tension-type headache (ICHD-II 2.2/2.3), and other severe neurologic or psychiatric disorders
.

In the end, the number of migraines was decreased in the active treatment group, as was the amount of medication required. There was also an increase in the number of patients who reported a 50% decrease in attacks.

A third study describing the sedative effect of Cefaly used a slightly different protocol in an attempt to control for the patient’s ability to sense the electric current by using controls and sham neurostimulation.

We performed a double-blind crossover sham-controlled study of 30 subjects to assess the effect on vigilance of different protocols of supra-orbital TNS. Each subject was tested in 4 different experimental conditions: without neurostimulation device (blank control: BC), with a sham neurostimulation (Sham control: SC), with a low frequency neurostimulation (LFN) and with a high frequency neurostimulation (HFN)
Results are compatible with decreased vigilance and arousal studies, but show no indication of inducing or improving sleep. Sedation may help some patients with migraine, but decreased arousal during sleep has been associated with sufferers.

The primary Cefaly site lists only the 3 studies described here, while the Canadian site, at least at the time of this writing, still contains the entire list of irrelevant studies with the misleading headings I discussed in my previous article. I’m not going to comment on the testimonials except to say that my degree of skeptism of any treatment is directly proportional to the number of testimonials used in advertising.

These studies show the possibility of Cefaly as a partial prophylactic for some types of migraines, but but no indication it is useful as a treatment for an ongoing attack.
http://www.skepticnorth.com/2014/03/update-on-cefaly/
 
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