Status:
COMPLETED
Efficacy and Mechanism of rTMS in Children With ASD: an Open-label Clinical Trial
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
Shanghai Mental Health Center
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
6-10 years
Phase:
NA
Brief Summary
This study is a 6-week open-label clinical trial involving 20 children aged 6-10 years with autism spectrum disorder. During the study, subjects received repeated transcranial magnetic stimulation（rTM...
Detailed Description
Participants will receive continuous theta burst stimulation (cTBS) for a 10-day period (10 sessions). If feasible for the participant, all stimulation sessions will be held at the same time of the da...
Eligibility Criteria
Inclusion
- Children aged 6-10 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.
- IQ ≥70.
- Informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
January 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05238298
Start Date
January 28 2022
End Date
April 1 2022
Last Update
May 5 2022
Active Locations (1)
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1
ShanghaiXinhua
Shanghai, Shanghai Municipality, China, 200092