Actively Recruiting
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
Led by National Institute of Mental Health (NIMH) · Updated on 2025-11-24
219
Participants Needed
1
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 interview at the study end. For the full trial, a 1-month follow-up visit will be done by telehealth.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 8 to 16 years (including all months up to age 17)
- Diagnosis of ADHD with predominately inattentive or combined presentations, or significant impairing symptoms of inattention in two or more settings
- Children of any sex assigned at birth or race/ethnicity
- Children and parents willing to provide informed assent and consent
- Willingness to comply with all study procedures and availability for study duration
- For pilot only: If treated with psychostimulants, willing to stop medication 3 days before baseline and remain off until post-intervention assessment
- No psychotropic medications for at least 30 days before baseline assessment
You will not qualify if you...
- Cognitive impairment preventing study procedures, such as IQ under 70 or global intellectual disabilities
- History of severe migraines, vertigo, epilepsy (except febrile seizures), or serious balance disorders
- Uncorrected visual acuity impairments that would interfere with VR training
- Known pregnancy
- Psychotic disorders or current substance dependence
- Suicide risk determined at baseline interview
- Medical or psychiatric conditions that may confound study data or prevent use of VR headset
- Recent cognitive training for ADHD within three months
- Excessive discomfort or inability to use VR equipment due to physical factors
- For main trial only: Use of certain psychotropic medications (antipsychotics, mood stabilizers) that may interfere with the intervention
- For main trial only: Prior use of Floreo's ADHD cognitive training products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Susan J Persky, Ph.D.
CONTACT
D
Daniel S Pine, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here