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Accelerated continuous theta burst stimulation targeting left primary motor cortex for children with autism spectrum
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.
