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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
MinorPrimary completion pushed from Jun 1, 2028 to Sep 1, 2028Show 4 more changesShow less
Study completion pushed from Jun 1, 2028 to Nov 1, 2028
Interventions modified
Trial arms changed: 1 → 2
Site contact updated
MinorRe-verified, no change to tracked fields
MinorEligibility criteria expanded, about 120 words
Study description expanded, about 12 words
Minor3 versionsRe-verified since Sep 10, 2025, no change to tracked fieldsv319-v321
NotableLead sponsor: National Human Genome Research Institute (NHGRI) to National Institute of Mental Health (NIMH)v318
Show 43 earlier versionsHide 43 earlier versions
MinorRe-verified, no change to tracked fieldsv317
MinorEligibility criteria expanded, about 21 wordsv316
MinorRe-verified, no change to tracked fieldsv315
NotablePrimary completion date: Dec 31, 2025 to Jun 1, 2028
Study completion date: Aug 31, 2026 to Jun 1, 2028
v314
MinorRe-verified, no change to tracked fieldsv313
MinorEligibility criteria revisedv312
MinorStudy Status, Study Description, Eligibilityv311
Minor5 versionsRe-verified since Aug 31, 2024, no change to tracked fieldsv306-v310
MinorStudy Status, Contacts/Locationsv305
MinorStart date changed from estimate of Mar 22, 2024 to Mar 15, 2024v304
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MinorStart date: Feb 4, 2024 to Feb 5, 2024v275
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. Participants may have an MRI scan of the brain. They may also have magnetoencephalography (MEG) and electroencephalography (EEG) scans, which record brain activity using sensors placed near or on the head. These scans are optional.
Participants will receive a set of virtual reality games. The set includes 3 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, 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.
The brain scans may be repeated after the last game session. For the pilot, participants will have a final interview at the study end. For the full trial, a 1-month follow-up visit will be done by telehealth.