Accelerated continuous theta burst stimulation targeting left primary motor cortex for children with autism spectrum disorder: multicentre randomised sham controlled trial
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Published on: August 9, 2024
Hangyu Tan1, Tai Ren1, Aihua Cao2
1Department of Developmental and Behavioural Paediatric and Child Primary Care & Ministry of Education, Shanghai Key Laboratory of Children's Environmental Health, Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Insights
A five-day accelerated continuous theta burst stimulation (a-cTBS) protocol significantly improved social communication in children with autism spectrum disorder (ASD). This novel treatment demonstrated a favorable safety profile, offering a promising new therapy for ASD symptoms.
Area of Science:
- Neuroscience
- Developmental Psychology
- Clinical Trials
Background:
- Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by social communication impairments.
- Current therapeutic options for ASD have limitations, necessitating the exploration of novel interventions.
- Transcranial magnetic stimulation (TMS) techniques, including theta burst stimulation (TBS), show potential for modulating neural activity.
Purpose of the Study:
- To evaluate the efficacy and safety of a five-day accelerated continuous theta burst stimulation (a-cTBS) protocol for improving social communication in children with ASD.
- To assess the durability of treatment effects at one-month follow-up.
Main Methods:
- A multicenter randomized sham-controlled trial involving 200 children (aged 4-10 years) with ASD.
- Participants received either active a-cTBS or sham treatment targeting the left primary motor cortex for five consecutive days.
- Social communication was assessed using the Social Responsiveness Scale, second edition (SRS-2), with language improvements as a secondary outcome.
Main Results:
- The a-cTBS group showed significantly greater reductions in SRS-2 scores compared to the sham group, both post-intervention and at one-month follow-up (P<0.001).
- Significant improvements in language abilities were observed in the a-cTBS group.
- All reported adverse events were mild to moderate and resolved without intervention, indicating a favorable safety profile.
Conclusions:
- A five-day a-cTBS protocol is effective in improving social communication impairments in children with ASD.
- The treatment demonstrates a favorable safety profile, supporting its potential as a viable and scalable therapeutic option for ASD.
- Further research may explore long-term effects and optimal stimulation parameters.
Objectives:
To investigate the efficacy and safety of a five day accelerated continuous theta burst stimulation (a-cTBS) protocol in improving social communication impairment in children with autism spectrum disorder.
Design:
Multicentre randomised sham controlled trial.
Setting:
Three academic hospitals across three provinces in China, conducted from July 2023 to October 2024.
Participants:
200 children aged 4-10 years with autism spectrum disorder (167 boys and 33 girls) all with a full scale intelligence quotient ≥50.
Interventions:
Participants were randomised 1:1 to receive active a-cTBS (n=100) or sham (n=100) treatment stratified by full scale intelligence quotient (≥70 or <70) and study site. Participants received 10 sessions each day for five consecutive days, targeting the left primary motor cortex. Participants and evaluators were masked to interventions.
Main Outcome Measures:
Two primary outcomes were assessed using the Social Responsiveness Scale, second edition (SRS-2): changes in social communication impairment from baseline to post-intervention and from baseline to one month follow-up. Primary analyses were conducted on a modified intention-to-treat population, including participants who received at least one stimulation session. Secondary outcomes included language improvements assessed from baseline to one month follow-up and changes in SRS-2 subscales.
Results:
Of the 200 participants, 198 were included in the modified intention-to-treat analysis (99 in each group) and 193 completed the full intervention. Compared with the sham group, the a-cTBS group showed significantly greater reductions in SRS-2 scores post-intervention (-6.25, 95% confidence interval -8.69 to -3.81; Cohen's d -0.92; P<0.001) and at one month follow-up (-6.17, -8.65 to -3.70; -0.90; P<0.001). Secondary outcomes also favoured a-cTBS, with significant improvements observed in language abilities (Cohen's d 0.12-0.47; all P<0.02; measured by Multilingual Assessment Instrument for Narratives). Reported adverse events were all mild to moderate and resolved without intervention.
Conclusions:
A five day a-cTBS protocol targeting the left primary motor cortex significantly improved social communication in children with autism spectrum disorder and showed a favourable safety profile. These findings support a-cTBS as a viable and scalable therapeutic option for children with autism spectrum disorder.
Trial Registration:
ClinicalTrials.gov NCT05927792.
