Clinical trial NCT05927792: Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorders
Official title: Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorders: a Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Autism Spectrum Disorder
Keywords: Repetitive Transcranial Magnetic Stimulation（rTMS）
Autism Spectrum Disorder
Intervention
Social Deficits
Language Function
Children
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Mental Health Center
name: Zhengzhou Children's Hospital, China
name: Qilu Hospital of Shandong University
First posted: 2023-07-03
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective, multicenter, randomized, single-blind controlled trial to enroll 200 children with autism spectrum disorders (ASD). The investigators hope to further explore the effectiveness of accelerated continuous theta-burst stimulation (a-cTBS) over the left primary motor cortex (M1) to improve core symptoms in ASD children based on a previous open-label clinical trial.

Detailed description: This study is a prospective, multicenter, randomized, single-blind controlled trial. Shanghai Xinhua hospital, Qilu hospital and Zhengzhou Children's hospital expect to enroll a total of 200 children with autism spectrum disorders (ASD) to participate in this trial.

The children seen at Department of Developmental Behavioral Child Health, who meet the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5) ASD diagnostic criteria and strict inclusion/exclusion criteria, can be enrolled for the intervention after informed consent.

At each study center, participants will be randomized into intervention group and sham group stratified by IQ level. The participants, their legal guardians, and the assessors were unaware of the grouping except for the intervention operator (single-blind).

During the trial, participants in intervention group will receive accelerated continuous theta-burst stimulation (a-cTBS) on the left primary motor cortex (M1) for 5 consecutive days. The sham group will be stimulated with a pseudo-stimulation coil, which emitted sounds with the same intensity, rhythm and vibratory sensation as the real stimulation, and the intervention target, duration and frequency are the same as the real intervention group.

All participants need to 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 investigators hope to further explore the effectiveness of accelerated continuous theta-burst stimulation (a-cTBS) over the left primary motor cortex (M1) to improve core symptoms in ASD children based on a previous open-label clinical trial and investigate the appropriate intervention model, effective adaptation population and underlying neurological mechanisms.

Eligibility criteria: Inclusion Criteria:

* Children aged 4-10 years old
* Meet the diagnostic criteria for ASD of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* ASD Diagnosis confirmed by the Autism Diagnostic Observation Schedule (ADOS) or Autism Diagnostic Interview, Revised (ADI-R)
* IQ of 50 or above
* Provide written informed consents

Exclusion Criteria:

* With metal implants in the body
* History of epilepsy or other neurological disease
* Require surgical treatment due to structural abnormalities indicated by brain MRI
* Diagnosed with genetic and chromosomal abnormalities
* With psychiatric/mental disorder (e.g., very early-onset schizophrenia) other than ASD
* Suffer from serious heart disease and/or severe hearing impairment
* Intracranial hypertension
* Participating in other clinical trials
* Participants who received other interventions within 4 weeks prior to enrollment.

Primary outcomes:
measure: Changes of Social Responsiveness Scale, Second Edition (SRS-2) scores from pre-intervention to post-intervention
timeFrame: within 2 weeks before the intervention (pre-intervention), within 3 days after the completion of the intervention course (post-intervention)
measure: Changes of Social Responsiveness Scale, Second Edition (SRS-2) scores from pre-intervention to 1 month follow-up
timeFrame: within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up)
Secondary outcomes:
measure: Chinese Communicative Development Inventory (CCDI)
timeFrame: within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up)
measure: Language Comprehension Test
timeFrame: within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up)
measure: Multilingual Assessment Instrument for Narratives (MAIN)
timeFrame: within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up)
measure: Clinical Global Impression Scale (CGI)
timeFrame: within 3 days after the completion of the intervention course (post-intervention), 1 month following the last intervention session (one month follow-up)
measure: Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
timeFrame: within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up)
measure: Electroencephalography (EEG)
timeFrame: within 2 weeks before the intervention (pre-intervention), within 2 days after the completion of the intervention course (post-intervention)
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Children's Hospital
state: Henan
city: Qilu
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Jiaotong University School of Medicine Xinhua Hospital
name: Fei Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: