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2015 ; 4
(2
): 135-47
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Transcutaneous Supraorbital Nerve Stimulation (t-SNS) with the Cefaly(®) Device
for Migraine Prevention: A Review of the Available Data
#MMPMID26467451
Riederer F
; Penning S
; Schoenen J
Pain Ther
2015[Oct]; 4
(2
): 135-47
PMID26467451
show ga
So far, among the different non-invasive neurostimulation methods, only
transcutaneous supraorbital nerve stimulation (t-SNS) with the Cefaly(®) (Cefaly
Technology sprl, Herstal, Belgium) device has randomized controlled trial-based
evidence for safety and efficacy and obtained American Food and Drug
Administration approval for the prevention of episodic migraine. In a
double-blinded, randomized, sham-controlled trial on 67 episodic migraine
patients (mean pre-treatment migraine days/month: 6.9), the 50% responder rate
after 3 months was significantly higher in the active group (38.2%) than in the
sham group (12.1%); attack frequency and total headache days were also
significantly reduced, but not headache severity. Acute anti-migraine drug intake
was reduced by 36.7% in the active group. Statistical sub-analysis suggested that
t-SNS was more effective in patients with a higher attack frequency. In a large
survey on 2313 Cefaly users about safety and satisfaction only 4.3% of subjects
reported side effects, all of which were minor and fully reversible, the most
frequent being intolerance to the paresthesia feeling and the most severe an
allergic skin reaction to the electrode gel. The efficacy/safety ratio of the
Cefaly device was therefore most favorable, especially when compared to
preventive anti-migraine drugs. The therapeutic efficacy of t-SNS with Cefaly
with low-frequency migraine (?5 attacks/month) was recently confirmed in an open
randomized trial. No published data are available in chronic migraine. According
to preliminary results of a fluorodeoxyglucose-positron emission tomography
study, Cefaly might exert its effect in migraine by increasing activity in
crucial areas of the limbic system and salience matrix such as orbitofrontal and
anterior cingulate cortices.