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Randomized Controlled Trial
. 2025 Apr 1;8(4):e255776.
doi: 10.1001/jamanetworkopen.2025.5776.

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

Zhenhuan Liu  1 , Sandra Zhong  2   3 , Roger C M Ho  4   5 , Xuguang Qian  1 , Yan Tang  6 , Hui Tian  1 , Chuntao Zhang  1 , Nuo Li  1 , Yong Zhao  1 , Yuqiong Zhang  7 , Huituan Liu  7 , Meifeng Wu  8 , Yingjie Zhan  9 , Min Li  10 , Zhihai Lv  11 , Fengyi Hao  4   12 , Wilson Tam  13 , Jeremy Lin Bingyuan  14   15 , Alvaro Pascual-Leone  16   17
Affiliations
Randomized Controlled Trial

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

Zhenhuan Liu et al. JAMA Netw Open. .

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 < .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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Conflict of interest statement

Conflict of Interest Disclosures: Dr Zhong reported being the founder of AscenZion Neuromodulation Co Pte Ltd. Dr Pascual-Leone reported receiving personal fees from AscenZion, Neuroelectrics, and Magstim, being a cofounder of TI Solutions, and being a cofounder and chief medical officer of Linus Health outside the submitted work; in addition, Dr Pascual-Leone had several patents issued related to noninvasive stimulation methods and combination of noninvasive stimulation with electroencephalography and neuroimaging. No other disclosures were reported.

Figures

Figure.
Figure.. Flow Diagram
tPCS indicates transcranial pulsed current stimulation.
See this image and copyright information in PMC

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References

    1. American Psychiatric Association . Diagnostic and Statistical Manual of Mental Disorders. 5th ed. American Psychiatric Association; 2013.
    1. Maenner MJ, Warren Z, Williams AR, et al. . Prevalence and characteristics of autism spectrum disorder among children aged 8 years—Autism and Developmental Disabilities Monitoring Network, 11 sites, United States, 2020. MMWR Surveill Summ. 2023;72(2):1-14. doi:10.15585/mmwr.ss7202a1 - DOI - PMC - PubMed
    1. Souders MC, Zavodny S, Eriksen W, et al. . Sleep in children with autism spectrum disorder. Curr Psychiatry Rep. 2017;19(6):34. doi:10.1007/s11920-017-0782-x - DOI - PMC - PubMed
    1. Liu X, Hubbard JA, Fabes RA, Adam JB. Sleep disturbances and correlates of children with autism spectrum disorders. Child Psychiatry Hum Dev. 2006;37(2):179-191. doi:10.1007/s10578-006-0028-3 - DOI - PubMed
    1. Polimeni MA, Richdale AL, Francis AJP. A survey of sleep problems in autism, Asperger’s disorder and typically developing children. J Intellect Disabil Res. 2005;49(pt 4):260-268. doi:10.1111/j.1365-2788.2005.00642.x - DOI - PubMed

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