Title : Effects of transcranial pulse stimulation on autism spectrum disorder: a double-blind, randomized, sham-controlled trial
Transcranial pulse stimulation (TPS) has been proven effective to improve cognition, memory and depressive symptoms on Alzheimer’s disease, but supporting evidence on other neurological diseases or neuropsychiatric disorders remains limited. We aimed to investigate the effects of TPS on right temporoparietal junction (rTPJ), a key node for social cognition for Autism Spectrum Disorder (ASD), and to examine the association between TPS, executive functions and social functions. This double-blind randomized, sham-controlled trial included 32 subjects (27 males), aged between 12-17, diagnosed with ASD. All eligible subjects were randomized into either the verum or the sham TPS group, on a 1: 1 ratio, based on the Childhood Autism Rating Scale (CARS) screening score. Sixteen subjects received 6 verum TPS sessions (energy level: 0.2-0.25 mJ/mm2, and 2.5-4.0 Hz pulse frequency, 800 pulse/session) in two weeks’ time on alternate days. Remaining sixteen subjects received sham TPS stimulation. The primary outcome measure was changes in CARS score, evaluated by parents, from baseline to 3-month follow-ups. Secondary outcomes included self-reported questionnaire responded by parents and cognitive tests responded by subjects. Clinical global impression-severity (CGI-S), improvement (CGI-I), efficacy (CGI-E), and total score (CGIT) were evaluated by a licensed mental health professional. Results showed that there were significant interaction effects in CARS and other secondary outcomes. Significant group and time effects were found in most secondary outcomes. There were also significant differences between the TPS group and the Sham TPS group in CARS, CGI(I), and CGI(T) immediately after 2-weeks' TPS intervention (all Ps < .05), and effects were sustainable at 1-and 3-month follow-up, compared with baseline. The effect size of CARS (d=0.83-0.95) and CGI(I) (d=4.12-4.37) were large to medium immediately after TPS intervention and sustained at 1- month post-stimulation, however; effects were reduced small at 3-month post-stimulation (d=2.31). The findings suggested that TPS over rTPJ was effective to reduce the core symptoms of ASD, as evidenced by a 24% reduction in the total CARS score in the verum TPS group. Additionally, the CGI total score had a 53.7% reduction in the verum TPS group at 3-month follow-up, compared with baseline. Although some of the neuropsychological tests’ results were deemed statistically insignificant, subjects in the verum TPS group had shown substantial improvement at 1-and 3-month follow-up, compared with baseline. Future replication of this study should include a larger sample derived from multi-nations to determine whether TPS could be considered as an alternative top-on treatment option in neuropsychiatry.
Audience Take Away
- To the best of our knowledge, this is the first RCT evaluating the effects of TPS in the treatment of core symptoms of ASD worldwide.
- TPS could be a safe and effective adjunct treatment for ASD adolescents
- The audience could learn about the technology and implications of TPS on neurodevelopmental disorders
- This evidence-based study provided insight for prospective study.