A Combined Topiramate and Repetitive Transcranial Magnetic Stimulation Protocol for Behavioral and Emotional Dysregulation: A Pilot Randomized Controlled Trial

The baseline-to-week-6 group-by-time effect was significant, F(2, 33) = 21.68, p = 9.73 × 10⁻⁷, partial η² = 0.568. Bonferroni-adjusted comparisons showed greater DERS reduction with the combination than with topiramate (mean difference in reduction 14.38 points, 95% CI 9.57–19.18, adjusted p = 0.000009, Cohen's d = 2.53) or rTMS (10.38 points, 95% CI 5.20–15.55, adjusted p = 0.0012, d = 1.70), whereas the two monotherapy groups did not differ after adjustment.

The combination group also showed the largest mean reductions in impulsivity and depressive symptoms and the most favorable clinician-rated global improvement. No participant in any arm reached the prespecified exploratory ≥30% DERS responder threshold. All 36 randomized participants completed the week-6 assessment, and no serious adverse events were recorded.

The absence of sham-rTMS and placebo medication prevents separation of intervention-specific effects from expectancy and other nonspecific effects. These pilot findings support procedural feasibility and provide preliminary effect estimates for a larger controlled trial; they should not be interpreted as confirmatory evidence of efficacy.</p>