TY - JOUR
T1 - Evaluating the Safety and Efficacy of Transcranial Pulse Stimulation on Autism Spectrum Disorder
T2 - A Double-Blinded, Randomized, Sham-Controlled Trial Protocol
AU - Cheung, Teris
AU - Ho, Yuen Shan
AU - Fong, Kwan Hin
AU - Lam, Yuen Ting Joyce
AU - Li, Man Ho
AU - Tse, Andy Choi Yeung
AU - Li, Cheng Ta
AU - Cheng, Calvin Pak Wing
AU - Beisteiner, Roland
N1 - Funding Information:
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).
Publisher Copyright:
© 2022 by the authors.
PY - 2022/12
Y1 - 2022/12
N2 - 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.
AB - 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.
KW - adolescents
KW - autism spectrum disorder
KW - efficacy
KW - neuromodulation
KW - RCT
KW - transcranial pulse stimulation
UR - http://www.scopus.com/inward/record.url?scp=85143725076&partnerID=8YFLogxK
U2 - 10.3390/ijerph192315614
DO - 10.3390/ijerph192315614
M3 - Journal article
C2 - 36497688
AN - SCOPUS:85143725076
SN - 1661-7827
VL - 19
JO - International Journal of Environmental Research and Public Health
JF - International Journal of Environmental Research and Public Health
IS - 23
M1 - 15614
ER -