The efficacy and safety repetitive transcranial magnetic stimulation in the treatment of migraine in children and adolescents: an open-label, single-arm, prospective, clinical trial

BACKGROUND: The article presents the results of a clinical study of repetitive transcranial magnetic stimulation (rTMS) in children with migraine.

AIM: To evaluate the efficacy and safety of rTMS in children with migraine.

METHODS: A open-label, single-arm, prospective cohort clinical study was conducted in 41 pediatric patients with migraine (mean age 12.34 ± 3.42 years) at Children’s City Polyclinic No. 39 in Moscow. In stage 1, we used rTMS of the left primary motor cortex at 70% of the motor threshold, 10 Hz (6-sec train, 45-sec inter-train interval), 600 stimuli per session, 3 sessions. If efficacy parameters were not achieved within one month (≥50% reduction in pain intensity and/or ≥30% reduction in the number of monthly headache episodes), patients were transferred to stage 2 with the following parameters: 10 daily sessions (excluding weekends) , 10 Hz, 70% of the motor threshold, 4-sec train, 11-sec inter-train interval , and 3000 stimuli per session. Efficacy was assessed based on changes in headache diary parameters, questionnaire scores, and instrumental findings.

RESULTS: In stage 1, 21.9% of patients achieved the efficacy criteria. In stage 2, positive changes were observed in headache intensity and frequency (p < 0.001): 28% of patients had a ≥50% reduction in pain intensity; 100% of patients had a ≥30% reduction in headache frequency. The HADS depression subscale score decreased by 41.7% (p < 0.001); the Spielberger–Hanin anxiety scale score decreased by 5.8 points for trait anxiety and by 7.6 points for state anxiety (p < 0.001); positive changes were observed on the CPAQ-R (5.2%, p = 0.003), and PedsQL (11.9%, p < 0.001).

CONCLUSION: rTMS of the left primary motor cortex significantly reduces the number of episodes and intensity of migraine headaches in children, reduces symptoms of anxiety and depression, positively affects quality of life and functional nervous system parameters, and is characterized by a favorable safety profile and good tolerability. Increasing the number of stimuli and sessions improves efficacy and increases the proportion of patients with a successful outcome.