TY - JOUR
T1 - Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura
T2 - a randomised, double-blind, parallel-group, sham-controlled trial
AU - Lipton, Richard B.
AU - Dodick, David W.
AU - Silberstein, Stephen D.
AU - Saper, Joel R.
AU - Aurora, Sheena K.
AU - Pearlman, Starr H.
AU - Fischell, Robert E.
AU - Ruppel, Patricia L.
AU - Goadsby, Peter J.
N1 - Funding Information:
RBL has received a clinical research grant from and holds stock options in Neuralieve; and has consulted for or undertaken research funded by other manufacturers of drugs and devices for migraine. DWD is an advisory board consultant to Neuralieve, Coherex, MAP, Merck, Minster, Ortho-McNeil, Endo, Allergan, and Pfizer; and is currently undertaking research supported by Advanced Neurostimulation Systems and Medtronic. SDS has received a clinical research grant from and holds stock options in Neuralieve. JRS is a consultant, advisory board member, or both for Allergan, Ortho-McNeil, Medtronic, Neuralieve, ANS, Pozen, and GlaxoSmithKline; has received research grants from GlaxoSmithKline, Merck, Allergan, Cypress, Eli Lilly, ANS, MAP Pharma, Schwartx, Capnia, Depomed, XLT, Schwartz, and NuPathe; and receives honoraria from GlaxoSmithKline, Merck, Ortho-McNeil, and Purdue Pharma. SKA received grant and research support from Advanced Bionics, Alexza, Allergan, GlaxoSmithKline, MAP Pharmaceuticals, Merck, Ortho-McNeil, Neuralieve, and Takeda; has served as a consultant for Ortho-McNeil Pharmaceutical, Merck, GlaxoSmithKline, Allergan, and Neuralieve; and has received honoraria from Merck, GlaxoSmithKline, NuPathe, and Ortho-McNeil Pharmaceutical. SHP served as a paid consultant in the interpretation of study results and publication of this clinical trial. REF is chief technology officer and board member of Neuralieve, co-invented the sTMS device used in this study, owns stock in the company, and has received money for travel expenses; his three sons each own stock in Neuralieve. PLR was contracted as a paid statistician to provide consultation and services for the design, operations, analysis, and reporting of results for this clinical trial. PJG is a consultant to and has received basic TMS research funding from Neuralieve; and has worked with or advised other devices companies, including ATI, Boston Scientific, and Medtronic.
PY - 2010/4
Y1 - 2010/4
N2 - 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.
AB - 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.
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U2 - 10.1016/S1474-4422(10)70054-5
DO - 10.1016/S1474-4422(10)70054-5
M3 - Article
C2 - 20206581
AN - SCOPUS:77949310480
SN - 1474-4422
VL - 9
SP - 373
EP - 380
JO - The Lancet Neurology
JF - The Lancet Neurology
IS - 4
ER -