Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorders

NCT05927792 | Completed Phase 2

• 1 other identifier: XHEC-C-2023-043
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

This study is a prospective, multicenter, randomized, single-blind controlled trial to enroll 200 children with autism spectrum disorders (ASD). The investigators hope to further explore the effectiveness of accelerated continuous theta-burst stimulation (a-cTBS) over the left primary motor cortex (M1) to improve core symptoms in ASD children based on a previous open-label clinical trial.

Conditions

Autism Spectrum Disorder

Keywords

Repetitive Transcranial Magnetic Stimulation（rTMS）; Autism Spectrum Disorder; Intervention; Social Deficits; Language Function; Children

Outcome Measures

Primary Outcomes (2)

• Changes of Social Responsiveness Scale, Second Edition (SRS-2) scores from pre-intervention to post-intervention

  SRS provides the multi-dimensional measure of social interaction allowing the rating of social impairment in ASD. SRS generates a total score and five theoretical subscale scores (labeled social awareness, social cognition, social communication, social motivation, restricted interests and repetitive behavior), and higher scores are indicative of greater social impairment.

  within 2 weeks before the intervention (pre-intervention), within 3 days after the completion of the intervention course (post-intervention)

• Changes of Social Responsiveness Scale, Second Edition (SRS-2) scores from pre-intervention to 1 month follow-up

  SRS provides the multi-dimensional measure of social interaction allowing the rating of social impairment in ASD. SRS generates a total score and five theoretical subscale scores (labeled social awareness, social cognition, social communication, social motivation, restricted interests and repetitive behavior), and higher scores are indicative of greater social impairment.

  within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up)

Secondary Outcomes (6)

• Chinese Communicative Development Inventory (CCDI)

  within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up)

• Language Comprehension Test

  within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up)

• Multilingual Assessment Instrument for Narratives (MAIN)

  within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up)

• Clinical Global Impression Scale (CGI)

  within 3 days after the completion of the intervention course (post-intervention), 1 month following the last intervention session (one month follow-up)

• Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)

  within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up)

Study Arms (2)

Intervention Group

EXPERIMENTAL

participants in intervention group will receive accelerated continuous theta-burst stimulation (a-cTBS) on the left primary motor cortex (M1) for 5 consecutive days.

Device: repeated transcranial magnetic stimulation (continuous theta-burst stimulation)

Sham Group

SHAM COMPARATOR

The sham group will be stimulated with a pseudo-stimulation coil, which emitted sounds with the same intensity, rhythm and vibratory sensation as the real stimulation, and the intervention target, duration and frequency are the same as the real intervention group.

Device: sham repeated transcranial magnetic stimulation

Interventions

repeated transcranial magnetic stimulation (continuous theta-burst stimulation) DEVICE

Participants in intervention group will receive cTBS over the left M1for 5 consecutive days. The detailed parameters as follows: 80% of resting motor threshold (RMT), 60 cycles of 10 bursts of three pulses at 50 Hz were delivered in 2-second trains (5 Hz) with no intertrain interval (i.e. triplet standard cTBS, 1800 pulses, 120s). Stimulation sessions were delivered hourly, 10 sessions were applied per day (18,000 pulses/day).

Intervention Group

sham repeated transcranial magnetic stimulation DEVICE

The sham group will be stimulated with a pseudo-stimulation coil, which emitted sounds with the same intensity, rhythm and vibratory sensation as the real stimulation, and the intervention target, duration and frequency are the same as the real intervention group.

Sham Group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4-10 years old
• Meet the diagnostic criteria for ASD of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
• ASD Diagnosis confirmed by the Autism Diagnostic Observation Schedule (ADOS) or Autism Diagnostic Interview, Revised (ADI-R)
• IQ of 50 or above
• Provide written informed consents

You may not qualify if:

• With metal implants in the body
• History of epilepsy or other neurological disease
• Require surgical treatment due to structural abnormalities indicated by brain MRI
• Diagnosed with genetic and chromosomal abnormalities
• With psychiatric/mental disorder (e.g., very early-onset schizophrenia) other than ASD
• Suffer from serious heart disease and/or severe hearing impairment
• Intracranial hypertension
• Participating in other clinical trials
• Participants who received other interventions within 4 weeks prior to enrollment.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Shanghai Mental Health Center: collaborator
• Zhengzhou Children's Hospital, China: collaborator
• Qilu Hospital of Shandong University: collaborator

Study Sites (3)

Henan Children's Hospital

Zhengzhou, Henan, 450000, China

Location

Qilu Hospital of Shandong University

Qilu, Shandong, 250000, China

Location

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Language

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication; Behavior

Study Officials

• Fei Li, MD, PhD

  Shanghai Jiaotong University School of Medicine Xinhua Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants, their legal guardians, and the assessors were unaware of the grouping except for the intervention operator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician ,Doctoral Supervisor

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 3, 2023
• Study Start: July 17, 2023
• Primary Completion: October 25, 2024
• Study Completion: October 31, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)