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NCT05608434Not yet recruiting

Development of Virtual Reality-based Interventions to Strengthen Cognitive Skillsets Related to Attention Deficit Hyperactivity Disorder (ADHD)

Development of Virtual Reality-based Interventions to Strengthen Cognitive Skillsets Related to Attention Deficit Hyperactivity Disorder (ADHD): A Randomized Controlled Phase II Trial
National Human Genome Research Institute (NHGRI)Phase 2ClinicalTrials.govbehavioral
Study focus
Drug/Device/Intervention
Floreo Virtual Reality application
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
National Human Genome Research Institute (NHGRI)
Funder
National Institutes of Health Clinical Center (CC)
Location
Bethesda, United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Feb 24, 2023
End date
Aug 31, 2026
Enrollment
219 participants
Primary outcome

ADHD-RS-5 inattention sub-scale.

Summary

Background:
 
 Children with attention deficit hyperactivity disorder (ADHD) often have cognitive problems.
 It may be hard for them to control their behaviors, concentrate for long periods, or make
 decisions. This can affect their education, friendships, and daily life. A virtual
 reality-based game may help improve cognitive skills in children with ADHD. It may also help
 change how the brain functions.
 
 Objective:
 
 To see if a virtual reality-based game helps improve thinking skills and brain function in
 children with ADHD.
 
 Eligibility:
 
 Children aged 7 to 14 years with ADHD.
 
 Design:
 
 Participants will be screened. Their physical and mental health, medical and family history,
 and intellectual and emotional development will be evaluated. They will have tests of their
 mood, memory, attention, thinking, and behavior. Blood or saliva may be collected.
 Participants may have an MRI scan of the brain.
 
 Participants will receive a set of virtual reality games. The set includes 6 different games
 played by placing a smartphone inside a virtual reality headset. The participant will play a
 game for 20 minutes at least 3 days a week for 4 to 6 weeks.
 
 The parent or caregiver will start each game using a tablet. Each of the 6 games is designed
 to help the participant practice specific cognitive skills. These include inhibition control,
 processing speed, and sustained attention.
 
 Participants will have interviews each week. They will answer questions about motion
 sickness, eye strain, or headache.
 
 Blood or saliva tests and the MRI may be repeated after the last game. A 6-month follow-up
 visit can be by phone or telehealth.

ICD-10 classifications
Neurotic disorder, unspecifiedHyperkinetic disorder, unspecifiedHabit and impulse disorder, unspecifiedMild cognitive disorderDisturbance of activity and attention
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05608434
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05608434 through Pure Global AI's free database. This Phase 2 trial is sponsored by National Human Genome Research Institute (NHGRI) and is currently Not yet recruiting. The study focuses on Attention Deficit Hyperactivity Disorder. Target enrollment is 219 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.