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BOSTON – Single-pulse transcranial magnetic stimulation (sTMS) may represent an effective prophylactic treatment for migraine, according to results from a multicenter observational study presented at the 59th annual scientific meeting of the American Headache Society.1
Although the use of sTMS for the treatment of acute migraine with aura was approved by the US Food and Drug Administration, its effectiveness as a preventive treatment has not been assessed. For the eNeura SpringTMS Post-Market Observational US Study of Migraine (ESPOUSE study; ClinicalTrials.gov Identifier: NCT02357381), a prospective, open-label, observational study, 263 patients with migraine (mean age, 42.8 years; 80.3% women; 85.6% white) were recruited between December 2014 and March 2016, 132 of which were eligible. The participants completed baseline assessment, met the inclusion criteria (ie, 5 to 25 headache days per month; headache day: ≥4 hours of moderate to severe headache-related pain), and used the sTMS device at least once during the 3-month study period.
Patients enrolled in the study initially had to monitor their headaches over a 1-month period, using diaries. They were then asked to use the stimulation device either preventively (4 pulses twice a day) or as an acute treatment (3 pulses every 15 minutes, up to 3 times). The primary end point effectiveness (ie, mean reduction of headache days compared with baseline period) showed significance with a mean reduction of -2.8 ± 0.4 headache days from baseline levels (9.1 days), which was superior to the set performance goal, “a statistically-derived, estimated placebo effect size, based on historical controls of -0.6 day reduction of headache days from baseline” (P <.0001). Adverse events (none serious; eg, lightheadedness, tingling) were reported by 19.4% of study participants and were estimated to be related to device use with varying degrees of certainty.
The researchers conclude that “This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention.”
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Starling AJ. A multicenter, prospective, single Arm, open label, post-market, observational study to evaluate the use of sTMS in reduction of migraine headache (ESPOUSE Study). Presented at: The American Headache Society 59th Annual Meeting. June 8-11, 2017; Boston, Massachusetts.