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

Richard B. Lipton, David William Dodick, Stephen D. Silberstein, Joel R. Saper, Sheena K. Aurora, Starr H. Pearlman, Robert E. Fischell, Patricia L. Ruppel, Peter J. Goadsby

Research output: Contribution to journalArticle

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Abstract

Background: 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. Methods: 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. Findings: 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. Interpretation: 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. Funding: Neuralieve.

Original languageEnglish (US)
Pages (from-to)373-380
Number of pages8
JournalThe Lancet Neurology
Volume9
Issue number4
DOIs
StatePublished - Apr 2010

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Migraine with Aura
Transcranial Magnetic Stimulation
Migraine Disorders
Hyperacusis
Photophobia
Therapeutics
Nausea
Epilepsy
Pain
Equipment and Supplies
Intention to Treat Analysis
Headache
Safety

ASJC Scopus subject areas

  • Clinical Neurology

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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. / Lipton, Richard B.; Dodick, David William; Silberstein, Stephen D.; Saper, Joel R.; Aurora, Sheena K.; Pearlman, Starr H.; Fischell, Robert E.; Ruppel, Patricia L.; Goadsby, Peter J.

In: The Lancet Neurology, Vol. 9, No. 4, 04.2010, p. 373-380.

Research output: Contribution to journalArticle

Lipton, Richard B. ; Dodick, David William ; Silberstein, Stephen D. ; Saper, Joel R. ; Aurora, Sheena K. ; Pearlman, Starr H. ; Fischell, Robert E. ; Ruppel, Patricia L. ; Goadsby, Peter J. / Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura : a randomised, double-blind, parallel-group, sham-controlled trial. In: The Lancet Neurology. 2010 ; Vol. 9, No. 4. pp. 373-380.
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AU - Saper, Joel R.

AU - Aurora, Sheena K.

AU - Pearlman, Starr H.

AU - Fischell, Robert E.

AU - Ruppel, Patricia L.

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