Randomized, Double-Blind Study of Closed-Loop Repetitive Transcranial Magnetic Stimulation to Prevent Migraine Over a Short Term

What this Trial Is About

Migraine is a common and disabling headache disorder characterized by moderate to severe headaches lasting 4 to 72 hours, often accompanied by nausea, vomiting, and sensitivity to sound and light. Researchers are evaluating the short-term effects of repetitive transcranial magnetic stimulation rTMS, a noninvasive and considered safe technique, for preventing migraines. This study aims to provide reliable data on rTMS use following guidelines for controlled migraine treatment trials, focusing on a brief treatment and follow-up period. Participants will be randomly assigned to receive either active rTMS treatment or a sham treatment as a control. The treatment involves three sessions of rTMS within 10 days, using Brightmind.AIs rTMS protocol, after a four-week baseline period. This is followed by a four-week follow-up to evaluate the short-term effects of the treatment on migraine prevention. During the study, participants will monitor their migraine days using a diary and attend study visits for assessments. Researchers will measure the number of monthly migraine days before and after treatment, along with other outcomes such as headache severity, duration, use of acute medication, and responder rates. The study includes safety monitoring and requires adherence to medication and treatment protocols over the entire study period, lasting approximately 8 weeks in total.

Closed-loop RTMS for Short-term Migraine Prevention