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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

repetitive Transcranial Magnetic Stimulation

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Repetitive Transcranial Magnetic Stimulation（rTMS）, Continuous theta Burst Stimulation （cTBS）

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

ShanghaiXinhua

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rTMS Group

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

ADHD Rating Scale

ADHD Rating Scale is the most widely used ADHD screening and treatment monitoring tools.

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.

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.

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.

Full Information

NCT ID

NCT05238298

First Posted

January 29, 2022

Last Updated

May 4, 2022

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai Mental Health Center

1. Study Identification

Unique Protocol Identification Number

NCT05238298

Brief Title

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

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

January 28, 2022 (Actual)

Primary Completion Date

March 29, 2022 (Actual)

Study Completion Date

April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rTMS Group

Arm Type

Experimental

Arm 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.

Intervention Type

Device

Intervention Name(s)

repetitive Transcranial Magnetic Stimulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Social Response Scale (SRS)

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Repetitive Stereotyped Behavior - Revised (RBS-R)

Description

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.

Time Frame

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

Title

ADHD Rating Scale

Description

ADHD Rating Scale is the most widely used ADHD screening and treatment monitoring tools.

Time Frame

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

Title

Behavior Rating Inventory of Executive Function(BRIEF)

Description

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.

Time Frame

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

Title

Childhood Autism Rating Scale (CARS)

Description

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.

Time Frame

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

Title

Clinical Efficacy Rating Scale (CGI)

Description

CGI is a scale used to assess the severity of the illness and the global improvement of the patient under intervention.

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Cambridge Neuropsychological Test Automated Battery (CANTAB)

Description

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.

Time Frame

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

Title

Continuous Operation Test (CPT)

Description

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.

Time Frame

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

Title

Resting State Electroencephalography

Description

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.

Time Frame

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

Title

Functional Near Infrared Spectroscopy , fNIRS

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fei Li, Director

Organizational Affiliation

Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

ShanghaiXinhua

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200092

Country

China

12. IPD Sharing Statement

Plan to Share IPD

No

Autism Spectrum Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial