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NCT Number: NCT05472870

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

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.

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Key information

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fei Li

Shanghai, Shanghai Municipality, 200092, China

About this study

This study is a single-arm open-label clinical trial, designed to enroll at least 30 children with ASD aged over 4 years old.

During the trial, participants will receive accelerated continuous theta-burst stimulation (a-cTBS)on the left primary motor cortex (M1) for 5 consecutive days and complete clinical assessments within 2 weeks before the cTBS intervention (pre-cTBS), repeated within 3 days after the completion of the cTBS course (post-cTBS) and 1 month following the last cTBS session (one month follow-up), respectively. 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 investigate the neurophysiological mechanism of rTMS for ASD children.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Social Response Scale (SRS) Scores

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

    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.

Secondary outcomes

  1. Childhood Autism Rating Scale (CARS)

    Time frame: Baseline, and 4 weeks after the completion of intervention.

    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.

  2. Behavior Rating Inventory of Executive Function (BRIEF)

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

    BRIEF is a quick and efficient measure of executive function(have school-age version (BRIEF-S) and preschool version (BRIEF-P)), we asked parents to complete the 86-item (BRIEF-S) or 63-item (BRIEF-P) form to rate a child's executive functions (1-3 score) within the context of his everyday environments (home or school).

    Here we report the BRIEF composite score, BRIEF-S score range is 86 -258 and BRIEF-P score range is 63-189. The higer scores indicate more impairment in executive function.

    We evaluate the changes in executive function (EF) scores before and after cTBS treatment.

  3. Conners Parent Symptom Questionnaire (PSQ)

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

    Conners Parent Symptom Questionnaire (PSQ) is a questionnaire screening for children's behavioral problems (especially with ADHD), it has 48 items(4-stage: 0-3) that can be divided into 6 factors (conduct problems, learning problems, psychosomatic problems, impulsive-hyperactivity, anxiety, and hyperactivity index). Add the scores and divide by the item numbers of each factor to get Z score.

    Here we mainly observe the changes in Hyperactivity Index (HI) Z scores, it ranges from 0-3, a higher score mean a worse outcome.

  4. Peabody Picture Vocabulary Test(PPVT)

    Time frame: Baseline, and 4 weeks after the completion of intervention.

    The Peabody Picture Vocabulary Test is one of the most commonly used assessment tests for measuring single-word comprehension. The raw score ranges from 0-110, the higher scores mean a better outcome. we collected the PPVT raw score from baseline to 1 months after treatment to evaluate the effect of rTMS treatment on ASD children's words comprehension.

  5. Chinese Communicative Development Inventory (CCDI)

    Time frame: Baseline and 4 weeks after the completion of intervention.

    CCDI provides a powerful tool to assess early vocabulary development and the language skills of older children with developmental disorders and the effectiveness of their intervention. Here we collected the CCDI words produced score, it ranges from 0-798. The higher scores mean a better outcome.

  6. Clinical Global Impression of Improvement (CGI-I)

    Time frame: After the completion of 5-days intervention and 4 weeks after the completion of intervention.

    CGI is a scale used to assess the severity of the illness and the global improvement of the patient under intervention. Here we used Clinical Global Impression of Improvement (CGI-I) to rate how much the patient's illness has improved or worsened relative to baseline (a seven-point scale: 1 = "very much improved" to 7 = "very much worse"). The CGI was carried out by trained clinical assessors according to children's CARS、ADOS assessment results and parent interviews before and after intervention. We calculated the number of subjects with improvement (CGI-I≤3).

  7. Repetitive Behaviors Scale - Revised (RBS-R)

    Time frame: baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.

    The Repetitive Behaviors Scale - Revised (RBS-R) is a 44-item (rated 0-3) 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.

    Here we use the RBS-R total score, it ranges from 0-132, the higher score means worse repetitive behavior.

Other outcomes

  1. Power Spectral Density (PSD) Within the Alpha Frequency Band

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

    For EEG data, we caculated the power spectral density (PSD) within the alpha frequency band (8-13 Hz) for all channels.

  2. Multilingual Assessment Instrument for Narratives (MAIN)

    Time frame: Baseline, and 4 weeks after the completion of intervention.

    For a subset of ASD children with adequate expressive ability (those able to at least use phrases), we use Multilingual Assessment Instrument for Narratives (MAIN) tool to assess their narrative comprehension and production skills. In this test, children were asked to tell and retell the story and answer comprehension questions, and then assessors scored children's performance from four dimensions (i.e., story structure, structural complexity, and internal state terms and comprehension questions). The story structure score range is 0-18, structural complexity score range is 0-4, internal state terms score range is 0-no limit, and comprehension questions score range is 0-10. The higher score means better performance.

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Shanghai Mental Health Center

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 25, 2022
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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