Transcranial Magnetic Stimulation for Migraine Prevention in Adolescents: A Pilot Open‐Label Study

Objective To assess the feasibility, tolerability, and patient acceptability of single‐pulse transcranial magnetic stimulation (sTMS) for migraine prevention in adolescents in an open‐label pilot study. Background Migraine is common in adolescents and can be disabling. Well tolerated preventative therapies that are safe and effective are needed. Methods This was an open‐label prospective pilot feasibility study of sTMS for migraine prevention in adolescents aged 12‐17 years. Participants used sTMS twice daily in a preventative fashion, as well as additional pulses as needed acutely. A 4‐week baseline run‐in period (weeks 1‐4) was followed by a 12‐week treatment period. Feasibility was the primary outcome. Secondary outcomes included tolerability and acceptability, as well as the change in headache days, number of moderate/severe headache days, days of acute medication use, and PedMIDAS (headache disability) scores between the run‐in period (weeks 1‐4) and the third month of treatment (weeks 13‐16). Results Twenty‐one participants enrolled. Nineteen completed the baseline run‐in, and 12 completed the study. Using sTMS proved feasible and acceptable with overall high compliance once treatment administration was streamlined. Initially, for preventive treatment, participants were asked to give 2 pulses, wait 15 minutes, then give 2 additional pulses twice daily. This 15‐minute delay proved challenging for adolescents, particularly on school days, and therefore was dropped. Study completion rate went from 4/13 (31%) to 7/8 (88%) once this change was made, P = .024. On average, participants used the device preventively between 22 and 24 days over a 28‐day block. There were no serious adverse events. Two participants reported mild discomfort with device use. Conclusion sTMS appears to be a feasible, well‐tolerated, and acceptable nonpharmacologic preventive treatment for migraine in adolescents. In designing future trials of sTMS for migraine prevention in adolescents, streamlined treatment administration will be essential to minimize drop‐out. Efficacy needs to be assessed in a larger trial.