Evaluating the Safety and Efficacy of Transcranial Pulse Stimulation on Autism Spectrum Disorder: A Double-Blinded, Randomized, Sham-Controlled Trial Protocol

Teris Cheung (), Yuen Shan Ho, Kwan Hin Fong, Yuen Ting Joyce Lam, Man Ho Li, Andy Choi-Yeung Tse, Cheng-Ta Li, Calvin Pak-Wing Cheng and Roland Beisteiner
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Teris Cheung: School of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR 999077, China
Yuen Shan Ho: School of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR 999077, China
Kwan Hin Fong: School of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR 999077, China
Yuen Ting Joyce Lam: School of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR 999077, China
Man Ho Li: Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong SAR 999077, China
Andy Choi-Yeung Tse: Department of Health and Physical Education, The Education University of Hong Kong, Hong Kong SAR 999077, China
Cheng-Ta Li: Department of Psychiatry, School of Medicine, National Yang Ming Chiao Tung University, Taipei 112, Taiwan
Calvin Pak-Wing Cheng: Department of Psychiatry, The University of Hong Kong, Hong Kong SAR 999077, China
Roland Beisteiner: Department of Neurology, Medical University of Vienna, 1090 Wien, Austria

IJERPH, 2022, vol. 19, issue 23, 1-9

Abstract: Autistic spectrum disorder (ASD) is a common developmental disorder in children. The latest non-intrusive brain stimulation (NIBS) technology—transcranial pulse stimulation (TPS)—has been proven effective in older adults with mild neurocognitive disorders and adults with major depressive disorder. Nonetheless, there is so far no robust randomized controlled trial (RCT) conducted on adolescents with ASD nationwide. This study proposes a two-armed (verum TPS group vs. sham TPS group), double-blinded, randomized, sham-controlled trial. Both groups will be measured at four timepoints, namely, baseline (T1), 2 weeks immediately after post-TPS intervention (T2), and at the 1-month (T3) and 3-month (T4) follow-ups. Thirty-four subjects, aged between 12 and 17, diagnosed with ASD will be recruited in this study. All subjects will be computerized randomised into the verum TPS group or the sham TPS group on a 1:1 ratio. All subjects will undertake functional MRI (fMRI) before and after the 2-weeks TPS interventions, which will be completed in 2 weeks’ time. This will be the first RCT evaluating the efficacy of TPS adolescents with ASD in Hong Kong. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT05408793.

Keywords: efficacy; transcranial pulse stimulation; RCT; autism spectrum disorder; neuromodulation; adolescents (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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