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NCT05608434 · ClinicalTrials.gov registry record · Phase 1
Development of Virtual Reality-based Interventions to Strengthen Cognitive Skillsets Related to Attention Deficit Hyperactivity Disorder (ADHD): A Pilot Phase I and Randomized Controlled Phase II Trial
A Phase 1 study of Attention Deficit Hyperactivity Disorder, sponsored by National Institute of Mental Health (NIMH).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 219
- Enrollment target
- 1
- Study location
NCT05608434: Recruiting Phase 1 study of Attention Deficit Hyperactivity Disorder, sponsored by National Institute of Mental Health (NIMH).
NCT05608434 is a Phase 1 study of Attention Deficit Hyperactivity Disorder that is actively recruiting participants, run by National Institute of Mental Health (NIMH). The registered enrollment target is 219 participants, roughly in line with the 214-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05608434, a Phase 1 study of Attention Deficit Hyperactivity Disorder, is actively recruiting participants, sponsored by National Institute of Mental Health (NIMH).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 219 participants
- Enrollment target
- 1
- Study location
Study 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. Virtual reality-based games may help improve cognitive skills in children with ADHD. It may also help change how the brain functions. Objective: To see if virtual reality-based games help improve thinking skills and brain function in children with ADHD. Eligibility: Children aged 8 to 16 years with ADHD. Design: We will first do a pilot study, meaning that everyone will receive the games. If this is successful, we will then conduct a randomized controlled trial, meaning that some participants will be randomly assigned to the full version of the games and some will be randomly assigned to a limited version. 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 4 different games all played using a virtual reality headset. The participant will play the games for 20 minutes 5 days a week for 4 weeks. The parent or caregiver will start each game using an iPad. Each of the games is designed to help the participant practice specific cognitive skills. These include inhibition control, processing speed, temporal information processing, and working memory. Participants will have interviews each week. They will answer questions about motion sickness, eye strain, headache, and any other side effects, as well as number of game sessions played. Blood or saliva tests and the MRI may be repeated after the last game session. For the pilot, participants will have a final intervie
Primary Outcome
The ADHD-RS-569 is a rating scale based on the diagnostic criteria for ADHD as described in the DSM-5. Inattention symptoms are one of two key symptom domains for ADHD, and the target of the present intervention.
Conditions Studied
Interventions
- BEHAVIORAL Floreo Virtual Reality application
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2024-03-15 |
| Est. Completion | 2028-06-01 |
| Phase | Phase 1 |
What NCT05608434 shows while recruiting
NCT05608434 is an interventional study that assigns participants to a tested intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 214-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target.
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 1 intervention - of which Floreo Virtual Reality application is the first listed.
NCT05608434 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05608434 about?
NCT05608434 is a clinical study titled "Development of Virtual Reality-based Interventions to Strengthen Cognitive Skillsets Related to Attention Deficit Hyperactivity Disorder (ADHD): A Pilot Phase I and Randomized Controlled Phase II Trial". 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. Virtual reality-based games may...
What is the current status of trial NCT05608434?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 219 participants. The study started on 2024-03-15. Estimated completion is 2028-06-01.
What conditions does trial NCT05608434 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.
What interventions are being tested in trial NCT05608434?
The interventions under investigation include: Floreo Virtual Reality application (BEHAVIORAL).
Who is sponsoring clinical trial NCT05608434?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05608434 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Attention Deficit Hyperactivity Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05608434's enrollment target sits among peer trials
219 31st of 102 higher than 72 of 102 other Attention Deficit Hyperactivity Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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