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, Choi Yeung Andy TSE, Cheng-Ta LI, Calvin Pak-Wing CHENG, Roland BEISTEINER

Research output: Contribution to journalArticlespeer-review

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. Copyright © 2022 by the authors.
Original languageEnglish
JournalInternational Journal of Environmental Research and Public Health
Volume19
Issue number23
Early online date24 Nov 2022
DOIs
Publication statusE-pub ahead of print - 24 Nov 2022

Citation

Cheung, T., Ho, Y. S., Fong, K. H., Lam, Y. T. J., Li, M. H., Tse, A. C.-Y., . . . Beisteiner, R. (2022). Evaluating the safety and efficacy of transcranial pulse stimulation on autism spectrum disorder: A double-blinded, randomized, sham-controlled trial protocol. International Journal of Environmental Research and Public Health, 19(23). Retrieved from https://doi.org/10.3390/ijerph192315614

Keywords

  • Efficacy
  • Transcranial pulse stimulation
  • RCT
  • Autism spectrum disorder
  • Neuromodulation
  • Adolescents

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