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Oxford University Press, Brain Communications, 2023

DOI: 10.1093/braincomms/fcad226

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Effects of transcranial pulse stimulation on autism spectrum disorder: a double-blind, randomized, sham-controlled trial

This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Data provided by SHERPA/RoMEO

Abstract

Abstract Transcranial pulse stimulation (TPS) has been proven effective to improve cognition, memory, and depressive symptoms of Alzheimer’s disease, but supporting evidence on other neurological diseases or neuropsychiatric disorders remains limited. This study aimed to investigate the effects of TPS on the right temporoparietal junction, which is a key node for social cognition for Autism Spectrum Disorder, and to examine the association between TPS and executive and social functions. This double-blinded, randomized, sham-controlled trial included 32 participants (27 males), aged 12–17years with Autism Spectrum Disorder. All eligible participants were randomized into either the verum or sham TPS group, on a 1: 1 ratio, based on the Childhood Autism Rating Scale (CARS) screening score. Sixteen participants received 6 verum TPS sessions (energy level: 0.2–0.25 mJ/mm2, and 2.5–4.0 Hz pulse frequency, 800 pulse/session) in two weeks on alternate days. The remaining 16 participants received sham TPS stimulation. The primary outcome measure included CARS score changes, evaluated by parents, from baseline to 3-month follow-ups. Secondary outcomes included a self-reported questionnaire responded to by parents and cognitive tests responded to by participants. A licensed mental health professional evaluated clinical global impression-severity (CGI-S), improvement (CGI-I), efficacy (CGI-E), and total score (CGI-T). Results revealed significant interactions in CARS and other secondary outcomes. Significant group and time effects were found in most secondary outcomes. Additionally, significant differences were found between the TPS and Sham TPS groups in CARS, CGI-I, and CGI-T immediately after 2 weeks of TPS intervention (all P < 0 .05), and effects were sustainable at 1-and 3-month follow-up, compared with baseline. The effect size of CARS (d= 0.83–0.95) and CGI-I (d =4.12–4.37) were large to medium immediately after intervention and sustained at 1-month post-stimulation; however, the effects were reduced to small at 3-month post-stimulation (d= 2.31). These findings indicated that TPS, over rTPJ, was effective to reduce the core symptoms of autism spectrum disorder, as evidenced by a 24% reduction in the total CARS score in the verum TPS group. Additionally, the CGI total score was reduced by 53.7% in the verum TPS group at a 3-month follow-up, compared with the baseline. Participants in the verum TPS group had shown substantial improvement at 1-and 3-month follow-up, compared with baseline, although some of the neuropsychological test results were deemed statistically insignificant. Future replication of this study should include a larger sample derived from multi-nations to determine TPS as an alternative top-on treatment option in neuropsychiatry.