N/A
Completed N=30
Efficacy and Mechanism of rTMS in Children With ASD: an Open-label Clinical Trial(Ⅱ)
Source: ClinicalTrials.gov NCT05472870 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Social Response Scale (SRS) Scores — 94.27; 81.50; 77.67 score on a scale — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Social Response Scale (SRS) Scores |
94.27; 81.50; 77.67 | <0.001 sig |
| SECONDARY Childhood Autism Rating Scale (CARS) |
33.48; 32.83 | — |
| SECONDARY Behavior Rating Inventory of Executive Function (BRIEF) |
153.76; 115.30; 152.76; 117.60; 149.12; 112.00 | — |
| SECONDARY Conners Parent Symptom Questionnaire (PSQ) |
1.20; 1.18; 1.10 | — |
| SECONDARY Peabody Picture Vocabulary Test（PPVT） |
67.78; 76.11 | — |
| SECONDARY Chinese Communicative Development Inventory (CCDI) |
733.00; 771.50 | — |
| SECONDARY Clinical Global Impression of Improvement (CGI-I) |
20; 27 | — |
| SECONDARY Repetitive Behaviors Scale - Revised (RBS-R) |
7.00; 7.00; 5.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05472870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.