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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04112758
Other study ID # 201903HM013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date January 23, 2022

Study information

Verified date January 2023
Source National Taiwan Normal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study mainly investigates the effect of high-intensity interval training on conflict monitoring in children with ADHD by using event-related potential and sLORETA techniques.


Description:

The present study will have two experiments, one is a cross-section study and the other is intervention study. As for cross-section study, typical developmental children and children with ADHD will perform the stroop task while recording their brain waves. The intervention is twice a week for 5 weeks and before and after the intervention, children with ADHD will randomly assign to either an exercise group or control group. They will perform the stroop task while recording their brain waves.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date January 23, 2022
Est. primary completion date April 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 12 Years
Eligibility Inclusion Criteria: 1. age between 7 and 12 years 2. diagnosed with ADHD by a pediatric psychiatrist, which is not required for TD 3. no history of brain injury or neurological conditions, such as exhibited epileptic seizures, serious head injuries, and periods of unconsciousness. Exclusion Criteria: 1. cannot follow the instruction 2. cannot complete all the procedure

Study Design


Related Conditions & MeSH terms


Intervention

Other:
High-intensity interval training
2 times weekly for 5 weeks Circuit training with 4 stations

Locations

Country Name City State
Taiwan National Taiwan Normal University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan Normal University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other Brain activation To examine sources relating to amplitude in ERPs, source localization will be conducted using standardized low resolution brain electromagnetic tomography (sLORETA) The sLORETA analysis with the ERP data will be selected by four 100 ms bins covering the period from 0 to 200 ms after stimulus-onset (0-50, 50-100, 100-150, and 150-200 ms). Day 0 and post-intervention at Week 5
Primary Behavioral performance reaction time (ms) is generated by computerized task de?ned as correct responses within the range from 200-1500 ms Day 0 and post-intervention at Week 5
Primary Behavioral performance response accuracy (percentage) is generated by computerized task defined as percentage of trials that successfully responded to target stimulus Day 0 and post-intervention at Week 5
Secondary N2 & P3 components Electroencephalographic (EEG) activity will be measured at 64 sites. The amplitude of the N2 is de?ned as the mean amplitude within a 50-ms interval surrounding the maximal negative peak within a 200- to 400-ms latency window.
The amplitude of the P3 is de?ned as the mean amplitude within a 50-ms interval surrounding the maximal positive peak within a 300- to 800-ms latency window.
Day 0 and post-intervention at Week 5
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