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; Roland Beisteiner

doi:10.3390/ijerph192315614

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

Int J Environ Res Public Health. 2022 Nov 24;19(23):15614. doi: 10.3390/ijerph192315614.

Authors

Teris Cheung^{1

2}, Yuen Shan Ho¹, Kwan Hin Fong¹, Yuen Ting Joyce Lam¹, Man Ho Li³, Andy Choi-Yeung Tse⁴, Cheng-Ta Li⁵, Calvin Pak-Wing Cheng⁶, Roland Beisteiner⁷

Affiliations

¹ School of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR 999077, China.
² The Mental Health Research Centre, The Hong Kong Polytechnic University, Hong Kong SAR 999077, China.
³ Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong SAR 999077, China.
⁴ Department of Health and Physical Education, The Education University of Hong Kong, Hong Kong SAR 999077, China.
⁵ Department of Psychiatry, School of Medicine, National Yang Ming Chiao Tung University, Taipei 112, Taiwan.
⁶ Department of Psychiatry, The University of Hong Kong, Hong Kong SAR 999077, China.
⁷ Department of Neurology, Medical University of Vienna, 1090 Wien, Austria.

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: RCT; adolescents; autism spectrum disorder; efficacy; neuromodulation; transcranial pulse stimulation.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Autism Spectrum Disorder* / psychology
Autism Spectrum Disorder* / therapy
Child
Double-Blind Method
Hong Kong
Humans
Randomized Controlled Trials as Topic
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT05408793

Grants and funding

This study is funded by the Start-up Fund for New Recruits, the Hong Kong Polytechnic University (ref. no.: P001496) and Associated Medical Supplies Co., Ltd., Hong Kong (ref. no.: P0039609).