Status:
COMPLETED
Effects of Transcranial Pulse Stimulation on ASD
Lead Sponsor:
The Hong Kong Polytechnic University
Conditions:
Autism Spectrum Disorder
High-functioning Autism
Eligibility:
All Genders
12-17 years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the efficacy and tolerability of TPS on young adolescents with ASD. Methods: This is a two-armed, randomized, double-blinded, sham-controlled trial. Sampling: A to...
Detailed Description
Primary objective: 1. Participants in the verum TPS group will have a significant reduction in CARS score at posttreatment compared with the sham TPS group. Secondary objectives: 2. Participants ...
Eligibility Criteria
Inclusion
- 12 -17 years of age
- Chinese ethnicity
- Diagnosis of Autistic Spectrum Disorder that meets the criteria of the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- No change in their management including medications or non-pharmacological intervention
- Currently taking prescribed psychotropic medications for ≥ 3 months
Exclusion
- A DSM-5 diagnosis other than ASD
- Concomitant major medical or neurological conditions, such as significant global developmental delay, skull defect, abnormal mass or tumor, or epilepsy
- A CARS score ≤ 30 (i.e., no ASD)
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05408793
Start Date
June 1 2022
End Date
December 6 2022
Last Update
March 13 2025
Active Locations (1)
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1
School of Nursing HongKongPolyU
Hong Kong, Hong Kong