A clinical study to assess the safety and efficacy of virtual reality devices that help diagnose Attention-Deficit / Hyperactivity disorder(ADHD)
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0008403
- Lead Sponsor
- Samsung Changwon Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
The eligible participants must meet all of the following criteria:
Individuals who are between 6 and 12 years old.
Individuals classified into either the disorder group or the control group according to the following criteria:
a) Disorder group: Individuals diagnosed with ADHD by a specialist in psychiatry.
b) Control group: Individuals diagnosed by a specialist in psychiatry as not having ADHD or any other mental disorder.
Individuals who have received sufficient explanation of this clinical trial, have understood it, and have voluntarily decided to participate and agreed to comply with the precautions.
Participants who meet any of the following criteria will be excluded from this clinical trial:
1)Individuals diagnosed with post-traumatic stress disorder, schizophrenia and other psychiatric disorders, bipolar disorder, pervasive developmental disorders, obsessive-compulsive disorder, severe depression, or severe anxiety disorders, conduct disorder, or other similar disorders.
2)Individuals who are currently taking ADHD medications (e.g., methylphenidate, atomoxetine, clonidine, guanfacine) or have a history of taking them within the past month.
3)Individuals who have attempted suicide within the past 3 months and have been identified as a high-risk group for suicide by a mental health professional.
4)Individuals who have started or are undergoing other cognitive and behavioral therapy within the past 3 months, including all types of cognitive and behavioral therapies, including ADHD.
5)Individuals who have physical impairments (e.g., hand/arm physical deformities, prostheses) that interfere with game play, as reported by parents or observed by the participant.
6)Individuals who have participated in another clinical trial within 90 days before the screening.
7)Individuals with an IQ of 70 or lower.
8)Individuals with color blindness.
9)Individuals with uncorrected vision (as determined by the participant's ability to play the game in the clinic).
10)Individuals who have difficulty using common equipment (such as smartphones or tablet PCs).
11)Individuals who fail to complete the AttnKare-D assessment during the baseline evaluation due to the final failure.
12)Individuals deemed unsuitable for clinical trial participation by the investigator for any other reason.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC of diagnostic results based on the distribution of the test device (AttnKare-D) and the reference standard (ADHD diagnosis by a specialist in psychiatry);Adverse events (AEs) occurred after the use of a medical device for clinical trials
- Secondary Outcome Measures
Name Time Method Sensitivity and specificity of diagnostic results of AttnKare-D based on the distribution and reference standard diagnosis of ADHD by a child and adolescent psychiatrist;Sensitivity, specificity, and AUC of diagnostic results based on the distribution of the AttnKare-D test and the evaluation results of the ADHD Rating Scale for Parent (K-ARS)