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

NCT ID: NCT05238298

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-28
• Study Completion Date: 2022-04-01

Brief Summary

This study is a 6-week open-label clinical trial involving 20 children aged 6-10 years with autism spectrum disorder. During the study, subjects received repeated transcranial magnetic stimulation（rTMS）intervention at the left primary motor cortex (M1) 5 times per day for 10 days. From the beginning of intervention to the end of 4 weeks after the completion of intervention, the subjects's clinical symptomatology, cognitive psychology, neuroimaging, and adverse events will be followed up.Our purpose is to explore whether rTMS can improve the clinical symptoms of children with autism spectrum disorder in China, and to explore the neurophysiological mechanism of rTMS for autistic children.

Detailed Description

Participants will receive continuous theta burst stimulation (cTBS) for a 10-day period (10 sessions). If feasible for the participant, all stimulation sessions will be held at the same time of the day. During this study，participants' clinical symptomatology, cognitive psychology, neuroimaging, and adverse events will be followed up for four times, specifically，before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention.

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 continuous theta burst stimulation (cTBS) for a 10-day period (10 sessions). If feasible for the participant, all stimulation sessions will be held at the same time of the 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 6-10 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.
• IQ ≥70.
• 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: 6 Years
• Maximum Eligible Age: 10 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, Director

Role: PRINCIPAL_INVESTIGATOR

Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine

Locations

ShanghaiXinhua

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

XHEC-C-2022-008

Identifier Type: -

Identifier Source: org_study_id