BackgroundTranscutaneous 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.MethodsOnly 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.ResultsAfter 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%.ConclusionsThis 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.
BackgroundPreventive pharmacotherapy for migraine is not satisfactory because of the low efficacy/tolerability ratio of many available drugs. Novel and more efficient preventive strategies are therefore warranted. Abnormal excitability of cortical areas appears to play a pivotal role in migraine pathophysiology. Transcranial direct current stimulation (tDCS) is a non-invasive and safe technique that is able to durably modulate the activity of the underlying cerebral cortex, and is being tested in various medical indications. The results of small open studies using tDCS in migraine prophylaxis are conflicting, possibly because the optimal stimulation settings and the brain targets were not well chosen. We have previously shown that the cerebral cortex, especially the visual cortex, is hyperresponsive in migraine patients between attacks and provided evidence from evoked potential studies that this is due to a decreased cortical preactivation level. If one accepts this concept, anodal tDCS over the visual cortex may have therapeutic potentials in migraine prevention, as it is able to increase neuronal firing.ObjectiveTo study the effects of anodal tDCS on visual cortex activity in healthy volunteers (HV) and episodic migraine without aura patients (MoA), and its potentials for migraine prevention.MethodsWe recorded pattern-reversal visual evoked potentials (VEP) before and after a 15-min session of anodal tDCS over the visual cortex in 11 HV and 13 MoA interictally. Then 10 MoA patients reporting at least 4 attacks/month subsequently participated in a therapeutic study, and received 2 similar sessions of tDCS per week for 8 weeks as migraine preventive therapy.ResultsIn HV as well as in MoA, anodal tDCS transiently increased habituation of the VEP N1P1 component. VEP amplitudes were not modified by tDCS. Preventive treatment with anodal tDCS turned out to be beneficial in MoA: migraine attack frequency, migraine days, attack duration and acute medication intake significantly decreased during the treatment period compared to pre-treatment baseline (all p < 0.05), and this benefit persisted on average 4.8 weeks after the end of tDCS.ConclusionsAnodal tDCS over the visual cortex is thus able to increase habituation to repetitive visual stimuli in healthy volunteers and in episodic migraineurs, who on average lack habituation interictally. Moreover, 2 weekly sessions of anodal tDCS had a significant preventive anti- migraine effect, proofing the concept that the low preactivation level of the visual cortex in migraine patients can be corrected by an activating neurostimulation. The therapeutic results indicate that a larger sham-controlled trial using the same tDCS protocol is worthwhile.
Electrophysiology is complementary to functional neuroimaging and will undoubtedly remain an important tool in headache research. One of its upcoming applications is to help select neurostimulation techniques and protocols that correct best the functional abnormalities detectable in certain headache disorders.
Background and Purpose: About half of the dysphagic stroke patients have persistent swallowing dysfunction after 7 days from symptom onset. The aim of the study was to evaluate incidence, prognosis, clinical and neuroradiological correlates of post-stroke dysphagia. Methods: We prospectively examined consecutive patients with acute ischemic or hemorrhagic stroke. Patients' clinical and neuroradiological data were collected. Swallowing function was assessed by the water swallow test upon admission and after 14 days; patients were then classified as persistent dysphagic, non-persistent dysphagic or non-dysphagic. Results: We recruited 275 patients, 121 of whom were dysphagic upon admission and 254 patients attended follow-up at 14 days; 141 never presented dysphagia, 21 had a non-persistent pattern of dysphagia and 92 had a persistent one. Stroke type, leukoaraiosis degree, previous cognitive impairment and stroke severity upon admission independently predicted the occurrence of dysphagia after stroke and its persistence as well. At receiver operating characteristic (ROC) analysis, the National Institutes of Health Stroke Scale (NIHSS) score of 11.5 was the best predictive value of persistent dysphagia, with a specificity of 90.1% and a sensitivity of 72.4%. Conclusion: Stroke severity is an important predictor of a persistent pattern of dysphagia, with a suggested NIHSS cutoff value of ≥12. An independent correlation was observed with leukoaraiosis and with previous cognitive impairment.
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