Status:
NOT_YET_RECRUITING
A Prospective, Single-Center, Single-Arm, Investigator-Initiated Exploratory Clinical Trial to Assess the Safety of Repetitive Transcranial Magnetic Stimulation for Children and Adolescents With Autism Spectrum Disorder
Lead Sponsor:
Bundang CHA Hospital
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
3-17 years
Phase:
NA
Brief Summary
This is a prospective, single-center, single-arm, investigator-initiated exploratory clinical trial aimed at evaluating the safety and exploring the efficacy of a medical electromagnetic stimulator de...
Eligibility Criteria
Inclusion
- Aged between 3 and 17 years at the time of enrollment
- Clinically diagnosed with Autism Spectrum Disorder (ASD), including assessment using the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
- Currently receiving outpatient care for ASD at the Department of Rehabilitation Medicine, CHA Bundang Medical Center
- The participant and their legal guardian have been fully informed of the study and have voluntarily provided written informed consent
Exclusion
- Diagnosed with a major neurological condition other than ASD
- Epileptiform discharges detected on EEG screening requiring initiation or adjustment of antiepileptic medication
- Diagnosed with other psychiatric disorders, such as schizophrenia or major depressive disorder
- History of traumatic brain injury, brain tumor, or other significant brain conditions
- Deemed unsuitable for participation by the principal investigator
- Currently participating in another interventional clinical trial, or has participated in one within the past 30 days (excluding observational studies)
- Any of the following contraindications to rTMS:
- Implanted electronic medical devices (e.g., pacemaker)
- Presence of metal implants in the skull
- Skin lesions at the stimulation site
- History of epilepsy
- Cervical spine pain or musculoskeletal disorders
- Pregnancy or currently breastfeeding
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06982586
Start Date
July 1 2025
End Date
December 31 2027
Last Update
May 21 2025
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