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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

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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Available from: Richard Lipton, Dec 02, 2015
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    • "Such an application has been approved for preventing migraine attacks by applying single TMS (sTMS) pulses to the occipital cortex during the visual aura. The rationale is to interrupt cortical spreading depression, presumably underlying the aura, and, in a controlled study, sTMS maintained pain freedom more than sham-stimulation (Lipton et al., 2010). "
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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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