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

Shanghai Jiao Tong University

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Device: repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05238298

XHEC-C-2022-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

rTMS Group

Experimental group

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.

Treatment:

Device: repetitive Transcranial Magnetic Stimulation