Status:
COMPLETED
Effect of Transcranial Pulse Stimulation on ADHD
Lead Sponsor:
The Hong Kong Polytechnic University
Conditions:
ADHD
Eligibility:
All Genders
12-17 years
Phase:
NA
Brief Summary
This is the first nationwide study using Transcranial Pulse Stimulation to evaluate its efficacy and safety on 30 young adolescents with ADHD. Six verum/ shamTPS sessions will be delivered to all subj...
Detailed Description
Objectives of the study 1. To evaluate the efficacy and safety of TPS on young adolescents (12-17 years) with ADHD in Hong Kong. 2. To examine the association between TPS and ADHD core symptom severi...
Eligibility Criteria
Inclusion
- have a confirmed diagnosis of ADHD according to the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) of the American Psychiatric Association;
- ethic Chinese, aged 12-17, with no co-morbidity of other mental disorders (e.g., Intellectual Disability Disorder) and organic brain diseases that affected cognitive functions;
- no severe systemic diseases including heart, liver, lung, and kidney diseases;
- have an IQ \>80 by Stanford-Binet Intelligence Scales, 5th Edition (SB-5);
- written consent by parents.
Exclusion
- SNAP IV score \<1;
- not taking ADHD medications in the past 2-4 weeks;
- treated with TMS/rTMS/tDCS or electroconvulsive therapy in the past 12 months;
- taking monoamine oxidase inhibitors in the past 14 days;
- have a history of epilepsy, brain trauma, brain surgery/brain tumour, brain aneurysm or other concomitant unstable major medical conditions like haemophilia or other blood clotting disorders or thrombosis;
- significant communicative impairments;
- having metal implants in the brain treatment region /artificial cardiac pacemaker in-situ;
- taking corticosteroid treatment within the last six weeks before the first TPS treatment;
- have a history of micro-cavernomas.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05422274
Start Date
June 1 2022
End Date
January 13 2023
Last Update
March 13 2025
Active Locations (1)
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1
School of Nursing HongKongPolyU
Hong Kong, Hong Kong