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Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomised, double-blind, parallel-group, sham-controlled trial

Department of Neurology, Albert Einstein College of Medicine, Bronx, NY 10461, USA
The Lancet Neurology (Impact Factor: 21.82). 03/2010; 9(4):373-80. DOI: 10.1016/S1474-4422(10)70054-5
Source: PubMed

ABSTRACT Preliminary work suggests that single-pulse transcranial magnetic stimulation (sTMS) could be effective as a treatment for migraine. We aimed to assess the efficacy and safety of a new portable sTMS device for acute treatment of migraine with aura.
We undertook a randomised, double-blind, parallel-group, two-phase, sham-controlled study at 18 centres in the USA. 267 adults aged 18-68 years were enrolled into phase one. All individuals had to meet international criteria for migraine with aura, with visual aura preceding at least 30% of migraines followed by moderate or severe headache in more than 90% of those attacks. 66 patients dropped out during phase one. In phase two, 201 individuals were randomly allocated by computer to either sham stimulation (n=99) or sTMS (n=102). We instructed participants to treat up to three attacks over 3 months while experiencing aura. The primary outcome was pain-free response 2 h after the first attack, and co-primary outcomes were non-inferiority at 2 h for nausea, photophobia, and phonophobia. Analyses were modified intention to treat and per protocol. This trial is registered with ClinicalTrials.gov, number NCT00449540.
37 patients did not treat a migraine attack and were excluded from outcome analyses. 164 patients treated at least one attack with sTMS (n=82) or sham stimulation (n=82; modified intention-to-treat analysis set). Pain-free response rates after 2 h were significantly higher with sTMS (32/82 [39%]) than with sham stimulation (18/82 [22%]), for a therapeutic gain of 17% (95% CI 3-31%; p=0.0179). Sustained pain-free response rates significantly favoured sTMS at 24 h and 48 h post-treatment. Non-inferiority was shown for nausea, photophobia, and phonophobia. No device-related serious adverse events were recorded, and incidence and severity of adverse events were similar between sTMS and sham groups.
Early treatment of migraine with aura by sTMS resulted in increased freedom from pain at 2 h compared with sham stimulation, and absence of pain was sustained 24 h and 48 h after treatment. sTMS could be a promising acute treatment for some patients with migraine with aura.
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    • "The effect of these stimulation methods is based on influencing neuronal activity and therefore, presumably, they can also interfere with the occurrence of cortical spreading depression (Leao, 1986). Studies have shown that migraine headache was diminished or stopped by application of two-pulses of TMS over the visual cortex or over the painful area (Clarke et al., 2006; Lipton et al., 2010). "
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    ABSTRACT: The present study aimed to investigate the efficacy of repetitive cathodal direct current stimulation (rctDCS) over the visual cortex as a prophylactic treatment in patients with menstrual migraine. 20 female patients were recruited in this double-blind, placebo-controlled study and were assigned to receive either cathodal or sham stimulation. Over 3 menstrual cycles, tDCS with 2mA intensity and 20min duration was applied to the visual cortex of the patients, in 5 consecutive sessions 1-5days prior to the first day of their menstruation. The primary endpoint of the study was the frequency of the migraine attacks at the end of the treatment period, however, additional parameters, such as the number of migraine related days and the intensity of pain were also recorded 3months before, during and 3months post-treatment. Visual cortex excitability was determined by measuring the phosphene thresholds (PTs) using single pulse transcranial magnetic stimulation (TMS) over the visual cortex. Sixteen patients completed the study. A significant decrease in the number of migraine attacks (p=0.04) was found in the cathodal group compared to baseline but not compared to sham (p=0.053). In parallel the PTs increased significantly in this group, compared to the sham group (p<0.05). Our results indicate that prophylactic treatment with rctDCS over the visual cortex might be able to decrease the number of attacks in patients with menstrual migraine, probably by modifying cortical excitability. Copyright © 2015 Elsevier B.V. All rights reserved.
    Journal of the neurological sciences 05/2015; 354(1-2). DOI:10.1016/j.jns.2015.05.009 · 2.26 Impact Factor
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    • "L'efficacité de la rTMS dans le traitement des céphalées a également été observée dans une étude de classe IV dans laquelle est décrite une amélioration des céphalées chez deux patients au cours d'un traitement par rTMS pour dépression chronique (rTMS préfrontale gauche à haute fréquence également) [311]. On distinguera ces résultats de protocoles rTMS « conventionnels » de l'efficacité toute relative et spéculative récemment rapportée avec des protocoles de simples ou doubles chocs [247]. Deux études contrôlées ont évalué l'efficacité de la rTMS dans le SDRC de type I et ont démontré une réduction significative de l'intensité de la douleur sur une courte période de suivi [329] [333]. "
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    ABSTRACT: During the past decade, a large amount of work on transcranial magnetic stimulation (TMS) has been performed, including the development of new paradigms of stimulation, the integration of imaging data, and the coupling of TMS techniques with electroencephalography or neuroimaging. These accumulating data being difficult to synthesize, several French scientific societies commissioned a group of experts to conduct a comprehensive review of the literature on TMS. This text contains all the consensual findings of the expert group on the mechanisms of action, safety rules and indications of TMS, including repetitive TMS (rTMS). TMS sessions have been conducted in thousands of healthy subjects or patients with various neurological or psychiatric diseases, allowing a better assessment of risks associated with this technique. The number of reported side effects is extremely low, the most serious complication being the occurrence of seizures. In most reported seizures, the stimulation parameters did not follow the previously published recommendations (Wassermann, 1998) [430] and rTMS was associated to medication that could lower the seizure threshold. Recommendations on the safe use of TMS / rTMS were recently updated (Rossi et al., 2009) [348], establishing new limits for stimulation parameters and fixing the contraindications. The recommendations we propose regarding safety are largely based on this previous report with some modifications. By contrast, the issue of therapeutic indications of rTMS has never been addressed before, the present work being the first attempt of a synthesis and expert consensus on this topic. The use of TMS/rTMS is discussed in the context of chronic pain, movement disorders, stroke, epilepsy, tinnitus and psychiatric disorders. There is already a sufficient level of evidence of published data to retain a therapeutic indication of rTMS in clinical practice (grade A) in chronic neuropathic pain, major depressive episodes, and auditory hallucinations. The number of therapeutic indications of rTMS is expected to increase in coming years, in parallel with the optimisation of stimulation parameters.
    Neurophysiologie Clinique/Clinical Neurophysiology 12/2011; 41(5-6):221-95. DOI:10.1016/j.neucli.2011.10.062 · 1.46 Impact Factor
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    • "A major consideration is the appropriate business model for a durable medical device, potentially able to deliver thousands of treatments. One case is the device tested for migraine (Lipton, et al., 2010), where one or two single pulses appear sufficient to abort an attack and there is little danger of harm from inappropriate use. A simple device capable of delivering isolated pulses could be disseminated among sufferers of a common disorder, such as migraine, where conventional pharmacological therapies have significant side effects and risks. "
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