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

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.

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

“…The full protocol of this clinical trial was published elsewhere. 14 This clinical trial was registered with ClinicalTrials.gov (NCT05408793) on 7 June 2022.…”

“…A sample size of 17 participants per group (34 participants in total) was deemed appropriate to detect the difference with 80% power in this study. 14 Unfortunately, two eligible participants (one in the verum TPS group and one in the sham TPS group) who undertook pre-TPS MRI were infected with coronavirus disease 2019 (COVID-19) with high fever and other COVID-19-related symptoms that required hospitalization, and parents were apprehensive to join this trial upon participants’ hospital discharge. Additionally, no eligible participants were on the waitlist when the extended recruitment period was over.…”

Efficacy and safety of transcranial pulse stimulation in young adolescents with attention-deficit/hyperactivity disorder: a pilot, randomized, double-blind, sham-controlled trial

“…Placebo effects must be considered when interpreting the results. The third study was a double-blind, randomized, sham-controlled trial evaluating the efficacy of TPS for autism spectrum disorder in 32 young adolescents (27 males) aged between 12 and 17 years in Hong Kong ( 40 , 41 ). This trial used the same stimulation protocol (energy level: 0.2–0.25 mJ/mm2, pulse frequency: 2.5–4.0 Hz, 800 pulses/session) over 2 weeks on alternate days, but the ASD trial targeted the rTPJ.…”