Research on improving ADHD symptoms using games
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0009326
- Lead Sponsor
- Woorisoft
- Brief Summary
Among the items of the Comprehensive Attention Test (CAT), the test group with NeuroWorld DTx digital therapy did not significantly increase compared to the control group with only existing drug therapy in the areas of omission error, false alarm error, forward response mean, and forward response standard deviation. Simple selectiveism (visual, auditory), inhibitory persistence, interference selectiveism, and divisionalism all showed a decreasing trend on the 28th day compared to baseline, so additional clinical trials are considered necessary. In the Korean version of the ADHD Rating Scale (K-ARS), the test group decreased by 20.81%, 23.82%, and 17.73%, respectively, in terms of total score, carelessness, and over-impulse. It is believed that clinical effectiveness can be confirmed through additional clinical trials. The Korean version of the Korean Child Behavior Checklist (K-CBCL) showed no significant difference between the test and control groups in the rate of change at 28 days compared to baseline, but it was confirmed that it steadily decreased on 14 and 28 days compared to baseline in all items. Among K-WISC-V), a processing speed (symbol writing and isomorphism finding) test was performed. As a result, it was confirmed that the rate of change on the 14th day in the sum of the converted scores was 0.64% lower in the test group than in the control group, but increased by 6.93% at the rate of change on the 28th day. Through this, it was confirmed that the parallelism of NeuroWorld DTx treatment improved visual injection, visual discrimination, visual short-term memory, and visual-exercise cooperation. In addition, there were no adverse events of frustration, headache, or dizziness in patients with ADHD during the clinical trial, confirming its safety.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
The criteria for selection were met by those who completed the voluntary written consent of the legal guardian to participate in the clinical trial, those who could follow the evaluation and guidelines of the clinical trial director, and those with normal intellectual function according to the Korean version of the Wexler Children’s Intelligence Test.
Those with disabilities or conditions other than ADHD (post-traumatic stress, psychosis, severe obsessive-compulsive disorder, severe depression), those who have difficulty using experimental products (physical deformities of hands or arms, prosthetic arms, etc.), those who have a history of drug abuse or dependence within six months, those who participated in other ADHD-related studies within 90 days of screening, those who are colorblind, those who have registered or are participating in the same study in their families, and those who were judged to be unfit to participate in the study were excluded from the study.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of change in Comprehensive Attention Test (CAT);Adverse events (frustration, headache, dizziness)
- Secondary Outcome Measures
Name Time Method Rate of change in Korean ADHD Rating Scale (K-ARS);Rate of change in Korea-Child Behavior Checklist (K-CBCL);Rate of change in Korean Wechsler Intelligence Scale for Children-Fifth Edition (K-WISC-V);Rate of change in Frankfurter Aufmerkasamkeits Inventar (FAIR)