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

NCT05238298 | Completed

• 1 other identifier: XHEC-C-2022-008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Repetitive Transcranial Magnetic Stimulation（rTMS）; Continuous theta Burst Stimulation （cTBS）

Outcome Measures

Primary Outcomes (1)

• Social Response Scale (SRS)

  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.

  Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention

Secondary Outcomes (5)

• 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

• ADHD Rating Scale

  Before intervention, 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

• Clinical Efficacy Rating Scale (CGI)

  5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention

Other Outcomes (4)

• Cambridge Neuropsychological Test Automated Battery (CANTAB)

  Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention

• Continuous Operation Test (CPT)

  Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention

• Resting State Electroencephalography

  Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention

Study Arms (1)

rTMS Group

EXPERIMENTAL

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.

Device: repetitive Transcranial Magnetic Stimulation

Interventions

repetitive Transcranial Magnetic Stimulation DEVICE

A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.

rTMS Group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Shanghai Mental Health Center: collaborator

Study Sites (1)

ShanghaiXinhua

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Fei Li, Director

  Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician ,Doctoral Supervisor

Study Record Dates

• First Submitted: January 29, 2022
• First Posted: February 14, 2022
• Study Start: January 28, 2022
• Primary Completion: March 29, 2022
• Study Completion: April 1, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)