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

Primary Purpose

Autism Spectrum Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
repetitive Transcranial Magnetic Stimulation
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

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

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fei Li

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 5-day period (5 sessions), at an intensity that is 80% of the resting motor threshold (RMT) . cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).

Outcomes

Primary Outcome Measures

Change in 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 1 month after treatment to evaluate the effect of rTMS treatment on ASD children.

Secondary Outcome Measures

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 1 months after treatment to evaluate the effect of rTMS treatment on ASD. children.
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.
Conners Scale
Conners is a questionnaire that asks about things like behavior, work or schoolwork, and social life. The answers show ADHD symptoms and how serious they are. There，parents fill out scales for children.
Repetitive Stereotyped Behavior - Revised (RBS-R)
The Repetitive Behaviors Scale - Revised (RBS-R) is a 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.
Peabody Picture Vocabulary Test（PPVT）
The Peabody Picture Vocabulary Test is one of the most commonly used assessment tests that measure verbal ability. Change of the score from baseline to 1 months after treatment to evaluate the effect of rTMS treatment on ASD children's verbal ability.
Chinese Communicative Development Inventory (CCDI)
CCDI provides a powerful tool to assess early vocabulary development ，and it is a reliable predictor of children's later language skills. Change of the score from baseline to 1 months after treatment to evaluate the effect of rTMS treatment on ASD children's language.
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

First Posted
July 22, 2022
Last Updated
July 24, 2022
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05472870
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

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
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This study is a open-label clinical trial involving over 30 children aged ≥4 years with autism spectrum disorder. During the study, subjects received repeated transcranial magnetic stimulation (rTMS) intervention at the left primary motor cortex (M1) 10 times per day for 5 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. Based on results from a recent unpublished pilot data, the investigators propose that cTBS treatment will induce a significant improvement in verbal/social communication performance in ASD children.
Detailed Description
Participants will receive continuous theta burst stimulation (cTBS) for a 5 day period (5 sessions), 10 times a day, for about 3min each. 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 three times, specifically before intervention, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.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 explore the neurophysiological mechanism of rTMS for autistic children.

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
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rTMS Group
Arm Type
Experimental
Arm Description
Participants will receive continuous theta burst stimulation (cTBS) for a 5-day period (5 sessions), at an intensity that is 80% of the resting motor threshold (RMT) . cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
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
Change in 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 1 month after treatment to evaluate the effect of rTMS treatment on ASD children.
Time Frame
Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
Secondary Outcome Measure Information:
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 1 months after treatment to evaluate the effect of rTMS treatment on ASD. children.
Time Frame
Baseline, immediately after the completion of 5-days 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
Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
Title
Conners Scale
Description
Conners is a questionnaire that asks about things like behavior, work or schoolwork, and social life. The answers show ADHD symptoms and how serious they are. There，parents fill out scales for children.
Time Frame
Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
Title
Repetitive Stereotyped Behavior - Revised (RBS-R)
Description
The Repetitive Behaviors Scale - Revised (RBS-R) is a 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
Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
Title
Peabody Picture Vocabulary Test（PPVT）
Description
The Peabody Picture Vocabulary Test is one of the most commonly used assessment tests that measure verbal ability. Change of the score from baseline to 1 months after treatment to evaluate the effect of rTMS treatment on ASD children's verbal ability.
Time Frame
Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
Title
Chinese Communicative Development Inventory (CCDI)
Description
CCDI provides a powerful tool to assess early vocabulary development ，and it is a reliable predictor of children's later language skills. Change of the score from baseline to 1 months after treatment to evaluate the effect of rTMS treatment on ASD children's language.
Time Frame
Baseline 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
After the completion of 5-days intervention and 4 weeks after the completion of intervention.
Other Pre-specified Outcome Measures:
Title
Resting State Electroencephalography(EEG)
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
Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
Title
Multilingual Assessment Instrument for Narratives (MAIN)
Description
For high-function ASD children，we use MAIN tool to assess narrative comprehension and production skills.
Time Frame
Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fei Li
Organizational Affiliation
Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fei Li
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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