Safety and Efficacy of Deep Transcranial Magnetic Stimulation for Management of Emotional Dysregulation in Children and Adolescents with Externalizing Behavior Disorders: Protocol of a Transdiagnostic Sham Controlled fMRI Study

Abstract

Background: High-frequency deep transcranial magnetic stimulation (dTMS) on the anterior cingulate cortex (ACC) and medial prefrontal cortex (mPFC) has been known to be effective in modulating emotional experience but not studied in children and adolescents with externalizing behavior disorders (EBDs). We present a novel protocol for a study that aims to assess the safety and efficacy of adjuvant dTMS in managing emotional dysregulation in EBDs in children and adolescents. Methods: The trial is prospectively registered in the Clinical Trial Registry of India (CTRI) at www.ctri.nic.in with registration number: CTRI/2023/03/050701. In total, 40 subjects with age less than 18 years with EBDs would be randomized into two groups (active and sham dTMS); receiving 15 sessions of high-frequency dTMS, each, over 3 weeks. The subjects and rater would remain blind to treatment allocation. Assessments would be done at baseline and immediately after completion of the treatment using the Child Behavior Checklist (CBCL), Difficulty in Emotional Regulation Scale (DERS), Modified Overt Aggression Scale (MOAS), Affective Reactivity Index (ARI), Barratt’s Impulsivity Scale (BIS), Drug Abuse Screening Test (DAST), Children Global Assessment Scale (CGAS), and Clinical Global Impression (CGI). A checklist for side effects will be administered following each session in both groups. Result: Data shall be analyzed utilizing the statistical software Statistical Package for Social Sciences for outcome variables as defined for the purpose of the study. Safety of dTMS in young subjects as assessed by TMSens_Q and reduction in scores of DERS would be primary outcome variables. Functional Magnetic Resonance Imaging (fMRI) task-based assessment of the difference in activation of mPFC and ACC at baseline and after application of dTMS and reduction in scores of BIS, ARI, MOAS, CGI, and CGAS would be measured as secondary outcome variables. Conclusion: The study’s results are going to provide insight into potential role of dTMS in addressing emotional dysregulation in EBDs in children and adolescents adding one more tool to the armamentarium.