Efficacy and Mechanism of Repeated Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorder: an Open-label Clinical Trial(Ⅱ)
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Social Response Scale (SRS) Scores
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Social Response Scale (SRS) Scores
Time Frame: Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
Social Response Scale (SRS) is a parent questionnaire used to assess the presence and severity of social impairment. The SRS generates a total score and five subscale scores (social awareness, social cognition, social communication, social motivation, and autistic mannerisms), and 5 subscales scores are summed to compute the total score; higher scores indicate greater social impairment. The SRS total score range is "0-195", the social awareness subscale score range is "0-24", the social cognition subscale score range is "0-36", the social communication subscale score range is "0-66", the social motivation subscale score range is "0-33", and the autistic mannerisms subscale score range is "0-36". We collected the SRS from baseline to 1 month follow-up to evaluate the effect of rTMS treatment on ASD syptoms among these children.
Secondary Outcomes
- Childhood Autism Rating Scale (CARS)(Baseline, and 4 weeks after the completion of intervention.)
- Chinese Communicative Development Inventory (CCDI)(Baseline and 4 weeks after the completion of intervention.)
- Behavior Rating Inventory of Executive Function (BRIEF)(Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.)
- Conners Parent Symptom Questionnaire (PSQ)(Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.)
- Clinical Global Impression of Improvement (CGI-I)(After the completion of 5-days intervention and 4 weeks after the completion of intervention.)
- Repetitive Behaviors Scale - Revised (RBS-R)(baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.)
- Peabody Picture Vocabulary Test（PPVT）(Baseline, and 4 weeks after the completion of intervention.)
Investigators
Fei Li
Chief Physician ,Doctoral Supervisor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine