Clinical trial NCT05472870: Efficacy and Mechanism of rTMS in Children With ASD: an Open-label Clinical Trial(Ⅱ)
Official title: Efficacy and Mechanism of Repeated Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorder: an Open-label Clinical Trial(Ⅱ)
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: 2022-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Social Response Scale (SRS) Scores
timeFrame: Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
Secondary outcomes:
measure: Childhood Autism Rating Scale (CARS)
timeFrame: Baseline, and 4 weeks after the completion of intervention.
measure: Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
measure: Conners Parent Symptom Questionnaire (PSQ)
timeFrame: Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
measure: Peabody Picture Vocabulary Test（PPVT）
timeFrame: Baseline, and 4 weeks after the completion of intervention.
measure: Chinese Communicative Development Inventory (CCDI)
timeFrame: Baseline and 4 weeks after the completion of intervention.
measure: Clinical Global Impression of Improvement (CGI-I)
timeFrame: After the completion of 5-days intervention and 4 weeks after the completion of intervention.
measure: Repetitive Behaviors Scale - Revised (RBS-R)
timeFrame: baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
Other outcomes:
measure: Power Spectral Density (PSD) Within the Alpha Frequency Band
timeFrame: Baseline, immediately after the completion of 5-days intervention.
measure: Multilingual Assessment Instrument for Narratives (MAIN)
timeFrame: Baseline, and 4 weeks after the completion of intervention.
Locations:
city: Shanghai
country: China
facility: Fei Li
state: Shanghai
Study officials:
affiliation: Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine
name: Fei Li
role: PRINCIPAL_INVESTIGATOR
References: