Efficacy and Mechanism of Repeated Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorder: an Open-label Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autism Spectrum Disorder
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Social Response Scale (SRS)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Fei Li
Chief Physician ,Doctoral Supervisor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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.
- •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.
Outcomes
Primary Outcomes
Social Response Scale (SRS)
Time Frame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
SRS is a questionnaire used to assess the presence and severity of social impairment, with high scores indicating severe symptoms. Change of the SRS from baseline to 3 month after treatment to evaluate the effect of computer social interaction treatment on ASD children.
Secondary Outcomes
- ADHD Rating Scale(Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention)
- Clinical Efficacy Rating Scale (CGI)(5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention)
- Behavior Rating Inventory of Executive Function(BRIEF)(Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention)
- Childhood Autism Rating Scale (CARS)(Before intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention)
- Repetitive Stereotyped Behavior - Revised (RBS-R)(Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention)