Clinical trial NCT05238298: Efficacy and Mechanism of rTMS in Children With ASD: an Open-label Clinical Trial
Official title: Efficacy and Mechanism of Repeated Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorder: an Open-label Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Repetitive Transcranial Magnetic Stimulation（rTMS）
Continuous theta Burst Stimulation （cTBS）
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Mental Health Center
First posted: 2022-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Social Response Scale (SRS)
timeFrame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Secondary outcomes:
measure: Repetitive Stereotyped Behavior - Revised (RBS-R)
timeFrame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
measure: ADHD Rating Scale
timeFrame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
measure: Behavior Rating Inventory of Executive Function(BRIEF)
timeFrame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
measure: Childhood Autism Rating Scale (CARS)
timeFrame: Before intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
measure: Clinical Efficacy Rating Scale (CGI)
timeFrame: 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Other outcomes:
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
measure: Continuous Operation Test (CPT)
timeFrame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
measure: Resting State Electroencephalography
timeFrame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
measure: Functional Near Infrared Spectroscopy , fNIRS
timeFrame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Locations:
city: Shanghai
country: China
facility: ShanghaiXinhua
state: Shanghai
Study officials:
affiliation: Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine
name: Fei Li, Director
role: PRINCIPAL_INVESTIGATOR
References: