Individuals with migraine enrolled in the prospective, nonrandomized, single-arm ESPOUSE study who received preventive single pulse transcranial magnetic stimulation (sTMS) showed a decrease in mean reduction of headache days from baseline when compared with statistically determined placebo controls, according to a recently published study in Cephalalgia.
Headache diaries detailing daily headache status, medication use, and device use were maintained for 1 month prior to treatments (baseline) and compared with data from a 28-day window following preventive sTMS treatment consisting of 4 pulses twice daily for 3 months. The primary end point was mean reduction of headache days compared with baseline, which was compared with a statistically derived placebo estimate (performance goal).
Of the 217 participants who received preventive sTMS treatments, baseline mean headache days were 9.06 days. Following treatment, the mean reduction in headache days from baseline was -2.75, and the performance goal was -0.63 days (P <.0001). Secondary outcomes measuring days of acute medication use, headache impact, and headache days of any intensity were also reduced.
Study investigators were also interested in detailing whether preventive sTMS was well tolerated. The most common adverse events were lightheadedness (3.7%), tingling (3.2%), and tinnitus (3.2%), with no serious adverse events. However, 9 participants (4%) withdrew from the study because of adverse events.
The study investigators wrote, “The simplicity, efficacy and tolerability of sTMS, combined with its dual utility as both an acute and preventive treatment option, may possibly increase adherence and compliance and improve patient outcomes.” They also added, “This study adds to the current evidence for acute migraine treatment that sTMS is a safe and possibly effective preventive treatment for migraine.”
Starling AJ, Tepper SJ, Marmura MJ, et al; A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study) [published March 4, 2018]. Cephalalgia. doi:10.1177/0333102418762525