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

NCT ID: NCT05927792

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-17
• Study Completion Date: 2024-10-31

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.

Detailed Description

This study is a prospective, multicenter, randomized, single-blind controlled trial. Shanghai Xinhua hospital, Qilu hospital and Zhengzhou Children's hospital expect to enroll a total of 200 children with autism spectrum disorders (ASD) to participate in this trial.

The children seen at Department of Developmental Behavioral Child Health, who meet the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5) ASD diagnostic criteria and strict inclusion/exclusion criteria, can be enrolled for the intervention after informed consent.

At each study center, participants will be randomized into intervention group and sham group stratified by IQ level. The participants, their legal guardians, and the assessors were unaware of the grouping except for the intervention operator (single-blind).

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

All participants need to complete clinical assessments within 2 weeks before the cTBS intervention (pre-cTBS), repeated within 3 days after the completion of the cTBS course (post-cTBS) and 1 month following the last cTBS session (one month follow-up), respectively.

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 and investigate the appropriate intervention model, effective adaptation population and underlying neurological mechanisms.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

repeated transcranial magnetic stimulation (continuous theta-burst stimulation)

Intervention Type: 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).

Sham Group

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.

Group Type: SHAM_COMPARATOR

sham repeated transcranial magnetic stimulation

Intervention Type: 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.

Interventions

repeated transcranial magnetic stimulation (continuous theta-burst stimulation)

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 Type: DEVICE

sham repeated transcranial magnetic stimulation

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: collaborator

Zhengzhou Children's Hospital, China

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Fei Li

Chief Physician ,Doctoral Supervisor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fei Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiaotong University School of Medicine Xinhua Hospital

Locations

Henan Children's Hospital

Zhengzhou, Henan, China

Qilu Hospital of Shandong University

Qilu, Shandong, China

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

XHEC-C-2023-043

Identifier Type: -

Identifier Source: org_study_id