Efficacy and Mechanism of rTMS in Children With ASD: an Open-label Clinical Trial(Ⅱ)

NCT ID: NCT05472870

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-12
• Study Completion Date: 2023-01-20

Brief Summary

This study is a open-label clinical trial involving over 30 ASD children aged ≥4 years old. During the study, subjects received repeated transcranial magnetic stimulation (rTMS) intervention on the left primary motor cortex (M1) 10 times per day for 5 consecutive days and complete clinical assessments from pre-intervention to post-intervention. This study hopes to explore whether accelerated continuous theta-burst stimulation (a-cTBS) over left primary motor cortex (M1) can improve clinical symptoms of children with ASD in China.

Detailed Description

This study is a single-arm open-label clinical trial, designed to enroll at least 30 children with ASD aged over 4 years old.

During the trial, participants will receive accelerated continuous theta-burst stimulation (a-cTBS)on the left primary motor cortex (M1) for 5 consecutive days and 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 purpose of this current study is to explore whether rTMS can improve the clinical symptoms of children with autism spectrum disorder in China, and to investigate the neurophysiological mechanism of rTMS for ASD children.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rTMS Group

Participants will receive cTBS over the left primary motor cortext (M1) for 5 consecutive days. The detailed parameters as follows: 80% of 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).

Group Type: EXPERIMENTAL

repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.

Interventions

repetitive Transcranial Magnetic Stimulation

A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Children aged ≥4 years.
• Meeting the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Edition 5 (DSM-5) .
• Confirmed by the ADOS and/or ADI-R diagnostic tool.
• Informed consent.

Exclusion Criteria

• Patients with metal implants .
• Patients with neurological diseases such as epilepsy .
• Patients requiring surgical treatment due to structural abnormalities indicated by brain MRI .
• Genetic or chromosomal abnormalities .
• Suffering from mental disorders (such as mood disorders, etc.)
• Suffering from serious heart disease .
• Hearing-impaired .
• 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: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

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

Role: PRINCIPAL_INVESTIGATOR

Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine

Locations

Fei Li

Shanghai, Shanghai Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

XHEC-C-2022-008-4

Identifier Type: -

Identifier Source: org_study_id