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

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Autism Spectrum Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05927792

XHEC-C-2023-043

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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

Treatment:

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

Sham Group

Sham Comparator group

Description:

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.

Treatment:

Device: sham repeated transcranial magnetic stimulation