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Simultaneous EEG Monitoring During Transcranial Direct Current Stimulation
Published on: June 17, 2013
Transcranial Pulsed Current Stimulation and Social Functioning in Children With Autism: A Randomized Clinical Trial
Zhenhuan Liu1, Sandra Zhong2,3, Roger C M Ho4,5
1Department of Paediatrics, Nanhai Maternity and Children's Hospital Affiliated to Guangzhou University of Chinese Medicine, Foshan, Guangdong, China.
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 < .001). Both treatments were well tolerated.
Conclusions And Relevance:
In this randomized clinical trial of prefrontal-cerebellar tPCS in children aged 3 to 14 years with ASD, 20 sessions over 4 weeks improved social functioning and sleep. These findings suggest that tPCS may serve as a viable nonpharmacologic alternative for ASD.
Trial Registration:
Chinese Clinical Trial Registry Identifier: ChiCTR2200059118.
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