Single pulse transcranial magnetic stimulation (sTMS) may be an effective, well-tolerated treatment option for migraine prevention, according to a recent study. Researchers conducted the eNeura Spring TMS Post-Market Observational US Study of Migraine (ESPOUSE), a multicenter, prospective, open label, observational study. Of the total subjects (n=263), 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The treatment protocol consisted of preventive (4 pulses twice daily) and acute (3 pulses repeated up to 3 times for each attack) treatment. Researchers found:
- The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set.
- For the primary endpoint, there was a −2.75 ± 0.40 mean reduction of headache days from baseline compared to the performance goal (-0.63 days).
- There was a reduction of −2.93 (5.24) days of acute medication use, headache impact measured by HIT-6, −3.1 (6.4), and total headache days of any intensity −3.16 days (5.21) compared to the performance goal (−0.63 days).
- The most common adverse events were lightheadedness, tingling, and tinnitus; there were no serious adverse events.
A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE study). [Published online ahead of print March 4, 2018]. Cephalalgia. doi:10.1177/0333102418762525.