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

NCT05472870 | Completed Results

• 1 other identifier: XHEC-C-2022-008-4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Social Response Scale (SRS) Scores

  Social Response Scale (SRS) is a parent questionnaire used to assess the presence and severity of social impairment. The SRS generates a total score and five subscale scores (social awareness, social cognition, social communication, social motivation, and autistic mannerisms), and 5 subscales scores are summed to compute the total score; higher scores indicate greater social impairment. The SRS total score range is "0-195", the social awareness subscale score range is "0-24", the social cognition subscale score range is "0-36", the social communication subscale score range is "0-66", the social motivation subscale score range is "0-33", and the autistic mannerisms subscale score range is "0-36". We collected the SRS from baseline to 1 month follow-up to evaluate the effect of rTMS treatment on ASD syptoms among these children.

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

Secondary Outcomes (7)

• Childhood Autism Rating Scale (CARS)

  Baseline, and 4 weeks after the completion of intervention.

• Behavior Rating Inventory of Executive Function (BRIEF)

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

• Conners Parent Symptom Questionnaire (PSQ)

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

• Peabody Picture Vocabulary Test（PPVT）

  Baseline, and 4 weeks after the completion of intervention.

• Chinese Communicative Development Inventory (CCDI)

  Baseline and 4 weeks after the completion of intervention.

Other Outcomes (2)

• Power Spectral Density (PSD) Within the Alpha Frequency Band

  Baseline, immediately after the completion of 5-days intervention.

• Multilingual Assessment Instrument for Narratives (MAIN)

  Baseline, and 4 weeks after the completion of intervention.

Study Arms (1)

rTMS Group

EXPERIMENTAL

Participants will receive cTBS over the left primary motor cortext (M1) for 5 consecutive days. The detailed parameters as follows: 80% of RMT, 60 cycles of 10 bursts of three pulses at 50 Hz were delivered in 2-second trains (5 Hz) with no intertrain interval (i.e. triplet standard cTBS, 1800 pulses, 120s). Stimulation sessions were delivered hourly, 10 sessions were applied per day (18,000 pulses/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: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

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)

Fei Li

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

Results Point of Contact

• Title: Fei Li
• Organization: Shanghai Jiaotong University School of Medicine Xinhua Hospital

feili@shsmu.edu.cn

18930830950

Study Officials

• Fei Li

  Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: July 22, 2022
• First Posted: July 25, 2022
• Study Start: July 12, 2022
• Primary Completion: December 15, 2022
• Study Completion: January 20, 2023
• Last Updated: August 21, 2024
• Results First Posted: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)