Evaluating the Safety and Efficacy of Transcranial Pulse Stimulation on Autism Spectrum Disorder
A Double-Blinded, Randomized, Sham-Controlled Trial Protocol
Bibliographic Data
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
Autism · Autism spectrum disorder · Brain stimulation · Clinical trial · Cognition · Neurocognitive · Physical medicine and rehabilitation · Physical therapy · Psychiatry · Randomized controlled trial · Stimulation · Transcranial Direct Current Stimulation · Transcranial magnetic stimulation · Medicine · Neurological disorders and treatments · Obsessive-Compulsive Spectrum Disorders · Psychology · Transcranial Magnetic Stimulation Studies · Internal Medicine
| Citation velocity | historical |
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| Highly cited | No |