Transcranial Pulsed Current Stimulation and Social Functioning in Children With Autism: A Randomized Clinical Trial

Abstract

IMPORTANCE Transcranial pulsed current stimulation (tPCS) may improve social functioning and sleep disorders in children with autism spectrum disorder (ASD). Prior trials have been limited by small sample sizes, single-center designs, and often a lack of sham controls. OBJECTIVE To examine the safety and efficacy of tPCS in improving social functioning and sleep disorders in children with ASD. DESIGN, SETTING, AND PARTICIPANTS This multicenter, double-blind, 2-armed, sham-controlled randomized clinical trial, conducted from May 1, 2022, through November 30, 2023, assessed children aged 3 to 14 years with ASD at 8 medical centers in China. INTERVENTIONS Participants underwent daily 20-minute sessions of active tPCS (0.7 mA) or sham tPCS (brief 0.7 mA ramp-up and ramp-down) for 20 sessions over 4 weeks with anode over the right cerebellar hemisphere and cathode over the left dorsolateral prefrontal cortex (12.56-cm2-circular, 4-cm-diameter circular electrodes). Each day after tPCS, all participants received 1 hour of standard therapy. MAIN OUTCOMES AND MEASURES Social functioning was assessed using the Autism Treatment Evaluation Checklist as the primary outcome. Secondary outcomes included the Autism Behavior Checklist and the Childhood Sleep Habits Questionnaire. RESULTS A total of 312 participants (155 in the active group and 157 in the sham group; 248 [79.5%] boys; mean [SD] age, 5.1 [1.6] years; 276 [88.5%] aged 3-6 years and 36 [11.5%] aged 7-14 years) completed the trial. After 20 sessions, the mean Autism Treatment Evaluation Checklist total score improved by 4.13 points (5.8%) in the sham tPCS group and 7.17 points (10.7%) in the active tPCS group. Analysis of covariance showed significantly greater improvement in the active tPCS group (difference, −3.50; 95% CI, −5.56 to −1.43; P