Lipton, R. B. et al. Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomized, double-blind, parallel-group, sham-controlled trial. Lancet Neurol. 9, 373-380

Department of Neurology, Albert Einstein College of Medicine, Bronx, NY 10461, USA
The Lancet Neurology (Impact Factor: 21.9). 03/2010; 9(4):373-80. DOI: 10.1016/S1474-4422(10)70054-5
Source: PubMed


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, 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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    • "While including a wide range of stroke patients with more severe deficits may reduce homogeneity, such inclusion would be beneficial in expanding enrollment that could allow for the study of subsets of patients with differing levels of impairment. For example, even within the clinical trial that led to approval of NIBS in migraine , only 40% of patients reported significant effects; however subset analyses revealed that patients on migraine preventative drugs had a select advantage to treatment [8] "
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    ABSTRACT: Stroke is a leading cause of long-term disability. Over 78% of patients never achieve normal levels of function despite rehabilitation [1]. The persistence of functional impairment underscores the need for new neurorehabilitative treatments. Non-invasive brain stimulation (NIBS) is one such technique that can directly boost underlying plasticity to augment rehabilitative recovery [2]. However, despite a significant body of evidence that has accumulated over the past decade [3], no NIBS modality is clinically approved for stroke rehabilitation.
    Journal of the Neurological Sciences 08/2015; DOI:10.1016/j.jns.2015.08.030 · 2.47 Impact Factor
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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 · 2.47 Impact Factor
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    • "The emerging transient patterns and their classification according to size and duration offer a model-based analysis of phase-dependent stimulation protocols for noninvasive neuromodulation devices, e.g., utilizing transcranial magnetic stimulation (TMS) [74], to intelligently target migraine. For instance, noise is a very effective method to drive the system back into the homogeneous steady state more quickly; see Fig. 12. "
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    ABSTRACT: Abstract Transient dynamics is pervasive in the human brain and poses challenging problems both in mathematical tractability and clinical observability. We investigate statistical properties of transient cortical wave patterns with characteristic forms (shape, size, duration) in a canonical reaction-diffusion model with mean field inhibition. The patterns are formed by ghost behavior near a saddle-node bifurcation in which a stable traveling wave (node) collides with its critical nucleation mass (saddle). Similar patterns have been observed with fMRI in migraine. Our results support the controversial idea that waves of cortical spreading depression (SD) have a causal relationship with the headache phase in migraine and, therefore, occur not only in migraine with aura (MA), but also in migraine without aura (MO), i.e., in the two major migraine subtypes. We suggest a congruence between the prevalence of MO and MA with the statistical properties of the traveling waves’ forms according to which two predictions follow: (i) the activation of nociceptive mechanisms relevant for headache is dependent upon a sufficiently large instantaneous affected cortical area; and (ii) the incidence of MA is reflected in the distance to the saddle-node bifurcation. We also observed that the maximal instantaneous affected cortical area is anticorrelated to both SD duration and total affected cortical area, which can explain why the headache is less severe in MA than in MO. Furthermore, the contested notion of MO attacks with silent aura is resolved. We briefly discuss model-based control and means by which neuromodulation techniques may affect pathways of pain formation.
    Journal of Mathematical Neuroscience 05/2013; 3(1):7. DOI:10.1186/2190-8567-3-7
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