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

Efficacy and Mechanism of Repeated Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorder: an Open-label Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: repetitive Transcranial Magnetic Stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • ShanghaiXinhua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rTMS Group; 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; A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repetitive Stereotyped Behavior - Revised (RBS-R)	The Repetitive Behaviors Scale - Revised (RBS-R) is a 44-item self-report questionnaire that is used to measure the breadth of repetitive behavior in children, adolescents, and adults with Autism Spectrum disorders. The RBS-R provides a quantitative, continuous measure of the full spectrum of repetitive behaviors. The RBS-R consists of six subscales including: Stereotyped Behavior, Self-injurious Behavior, Compulsive Behavior, Routine Behavior, Sameness Behavior, and Restricted Behavior, that have no overlap of item content.	Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
ADHD Rating Scale	ADHD Rating Scale is the most widely used ADHD screening and treatment monitoring tools.	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)	Specifically the investigators will evaluate the changes in executive function (EF) scores before and after cTBS treatment. The higer scores indicate more impairment in executive function.	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)	CARS is a behaviour-rating scale used to assess the presence and severity of the symptoms of autism spectrum disorder(ASD), with scores ranging from 15 to 60 and high scores indicating severe symptoms. Change of the CARS from baseline to 3 months after treatment to evaluate the effect of tablet computer social interaction treatment on ASD children.	Before intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Clinical Efficacy Rating Scale (CGI)	CGI is a scale used to assess the severity of the illness and the global improvement of the patient under intervention.	5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cambridge Neuropsychological Test Automated Battery (CANTAB)	CANTAB tests have demonstrated sensitivity to detecting changes in neuropsychological performance and include tests of working memory, learning and executive function; visual, verbal and episodic memory; attention, information processing and reaction time; social and emotion recognition, decision making and response control.	Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Continuous Operation Test (CPT)	To obtain reliable parameters of behavior, continuous performance tasks (CPTs) are usually used where the subject performs a constant-difficulty task for minutes or tens of minutes without interruptions.	Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Resting State Electroencephalography	There are three main parameters: phase locking value(PLV) , coherence (Coh) and the power spectral density of alpha band (PSD). PLV and Coh are estimated for exploring the functional connectivity between the targeted brain region and the rest regions of brain.	Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Functional Near Infrared Spectroscopy , fNIRS	Head fNIRs is a non-invasive, non-ionizing method for measuring and imaging the functional hemodynamic response to brain activity. It measures changes in hemoglobin (Hb) concentrations within the brain by means of the characteristic absorption spectra of Hb in the near-infrared range. Changes in the head fNIRs results of the subject before and after treatment.	Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborators: Shanghai Mental Health Center
• Investigators: Principal Investigator: Fei Li, Director, Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2022
• Primary Completion (Actual): March 29, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: January 29, 2022
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Repetitive Transcranial Magnetic Stimulation（rTMS）; Continuous theta Burst Stimulation （cTBS）
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: XHEC-C-2022-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No