2026-10-06T17:33:55Z https://api.figshare.com/v2/oai

oai:figshare.com:article/34050939 2026-10-02T00:28:33Z category_30373 item_type_3 month_year_10_2026

A Combined Topiramate and Repetitive Transcranial Magnetic Stimulation Protocol for Behavioral and Emotional Dysregulation: A Pilot Randomized Controlled Trial Zheng Xiuying (25160156) Sun Hongyi (25160159) Fu Xuebiao (25160160) Li Aiping (25160162) Zeng Ping (25160165) Luo Jinlin (25160168) Cognition Behavioral dysregulation emotional dysregulation topiramate repetitive transcranial magnetic stimulation neuromodulation impulsivity pilot study randomized controlled trial <p dir="ltr">Behavioral and emotional dysregulation is a clinically important transdiagnostic symptom domain associated with impulsivity, affective instability, and functional impairment across psychiatric disorders. This randomized, assessor-blinded pilot study evaluated the feasibility, preliminary clinical effects, and tolerability of a combined topiramate and repetitive transcranial magnetic stimulation (rTMS) intervention. Thirty-six adults were randomized 1:1:1 to topiramate monotherapy, rTMS monotherapy, or the combination intervention for 6 weeks. The primary outcome was change in Difficulties in Emotion Regulation Scale (DERS) total score from baseline to week 6. Mean DERS change was −8.3 ± 4.1 in the topiramate group, −12.3 ± 5.2 in the rTMS group, and −22.7 ± 6.9 in the combination group. 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> 2026-10-02T00:28:33Z Dataset Dataset 10.6084/m9.figshare.34050939.v1 https://figshare.com/articles/dataset/A_Combined_Topiramate_and_Repetitive_Transcranial_Magnetic_Stimulation_Protocol_for_Behavioral_and_Emotional_Dysregulation_A_Pilot_Randomized_Controlled_Trial/34050939 CC BY 4.0