35 research outputs found

    Safety and patients’ satisfaction of transcutaneous Supraorbital NeuroStimulation (tSNS) with the Cefaly® device in headache treatment: a survey of 2,313 headache sufferers in the general population

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    peer reviewedBACKGROUND: Transcutaneous supraorbital nerve stimulation (tSNS) with the Cefaly® device was recently found superior to sham stimulation for episodic migraine prevention in a randomized trial. Its safety and efficiency in larger cohorts of headache sufferers in the general population remain to be determined.The objective of this study was to assess the satisfaction with the Cefaly® device in 2,313 headache sufferers who rented the device for a 40-day trial period via Internet. METHODS: Only subjects using specific anti-migraine drugs, and thus most likely suffering from migraine, were included in the survey. Adverse events (AEs) and willingness to continue tSNS were monitored via phone interviews after the trial period. A built-in software allowed monitoring the total duration of use and hence compliance in subjects who returned the device to the manufacturer after the trial period. RESULTS: After a testing period of 58.2 days on average, 46.6% of the 2,313 renters were not satisfied and returned the device, but the compliance check showed that they used it only for 48.6% of the recommended time. The remaining 54.4% of subjects were satisfied with the tSNS treatment and willing to purchase the device. Ninety-nine subjects out of the 2,313 (4.3%) reported one or more AEs, but none of them was serious. The most frequent AEs were local pain/intolerance to paresthesia (47 subjects, i.e. 2.03%), arousal changes (mostly sleepiness/fatigue, sometimes insomnia, 19 subjects, i.e. 0.82%), headache after the stimulation (12 subjects, i.e. 0.52%). A transient local skin allergy was seen in 2 subjects, i.e. 0.09%. CONCLUSIONS: This survey of 2,313 headache sufferers in the general population confirms that tSNS with is a safe and well-tolerated treatment for migraine headaches that provides satisfaction to a majority of patients who tested it for 40 days. Only 4.3% of subjects reported AEs, all of them were minor and fully reversible

    External trigeminal nerve stimulation

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    Besides having incomplete efficacy, acute and preventive migraine drug treatments have minor and major contraindications and side effects, frequently leading to patients’ dissatisfaction and treatment discontinuation. There is thus a need to explore new therapeutic approaches that have a better efficacy over side effect profile. Targeting different pathophysiological aspects, many nondrug treatments have been tested in migraine. Among them, noninvasive peripheral neurostimulation of the first division of the trigeminal nerve—central cornerstone to the initiation and maintenance of migraine pain and associated symptoms—has attracted much attention recently. A transcutaneous external trigeminal nerve stimulation (eTNS) device called Cefaly®, developed and marketed by Cefaly Technology (Seraing, Liège, Belgium), has been approved for the acute and preventive treatment of migraine by the American Food and Drug Administration. In a sham-controlled, double-blind randomized trial (the PREMICE trial), the efficacy of eTNS with Cefaly® was found to be comparable to that of prophylactic pharmacotherapies. More recently, eTNS was also proven to be effective as abortive therapy. Possible mechanisms of action through which the device induces clinical improvement in migraine include short-term effects on the peripheral and long-term effects the central nervous system
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