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

NCT05608434 | Recruiting Phase 1

• 2 other identifiers: 10000744000744-M
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief 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 interview at the study end. For the full trial, a 1-month follow-up visit will be done by telehealth.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Smart Games; Neurodevelopmental; Virtual Reality; fMRI; Cognitive Training

Outcome Measures

Primary Outcomes (1)

• ADHD-RS-5 inattention sub-scale.

  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.

  within one month of the end of VR training

Secondary Outcomes (4)

• Number of correct responses on the NIH Toolbox Pattern Comparison Processing Speed Test.

  within one month of the end of VR training

• Number of correct responses on the Dot Matrix task

  within one month of the end of VR training

• Temporal deviation on a temporal reproduction task

  within one month of the end of VR training

• Stop signal reaction time on the Stop Signal task (inhibitory control)

  within one month of the end of VR training

Study Arms (1)

Floreo VR group

EXPERIMENTAL

This group will undergo up to 20 daily sessions (20 minutes each) of the Floreo VR training.

Behavioral: Floreo Virtual Reality application

Interventions

Floreo Virtual Reality application BEHAVIORAL

Floreo VR is a novel VR-based cognitive training therapy for ADHD. It incorporates multiple learning modules, each of which targets a neuropsychological domain relevant to ADHD (inhibitory control, working memory, temporal processing, processing speed). The demands of the training intervention adapt to the subject s practice-driven improvements in performance. Specifically, when the subject is deemed to perform adequately well at a given level of difficulty, the training adapts by presenting a more challenging difficulty. This adaptation to the subject s performance is designed to allow for continued incremental improvements in the trained domains. The VR games take place in a spaceship themed environment. The VR training is designed to be used at home, under the supervision of a parent.

Floreo VR group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• In order to be eligible to participate, an individual must meet all of the following criteria:
• Children must provide informed assent and parents must provide informed consent to participate in the study.
• Any sex assigned at birth, or race/ethnicity.
• Aged between 8 and 16 years of age, including all months leading up to age 17.
• Meets diagnosis for ADHD, predominately inattentive or combined presentations, or a specified presentation of having prominent symptoms of inattention that are impairing in two or more settings (but not numerous enough to meet a diagnosis of inattentive or combined presentation).
• Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study.
• For the Pilot only: If treated for ADHD with psychostimulants, willing to withdraw medication three days prior to baseline assessments and to stay off medication until completion of the post-intervention assessment. Not receiving any other psychotropic medication for at least 30 days prior to baseline assessment.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Cognitively not capable of performing study procedures. Indications of a lack of cognitive capacity could include a known IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.)
• History of severe migraines, vertigo, epilepsy (with the exception of febrile seizures), or serious balance disorders.
• Impairments in uncorrected visual acuity that would interfere with engagement with the VR training.
• Known to be pregnant.
• Considered a suicide risk as determined during the clinical interview at baseline.
• Any other medical or psychiatric condition that in the opinion of the PI may confound study data/assessments (e.g., limitations in mobility that would render the VR headset unusable).
• Recent (within three months) treatment with other cognitive training interventions (e.g., Cogmed) for ADHD.
• The VR equipment produces excessive discomfort to the child in the opinion of the PI (e.g., including participants with small interpupillary distances (IPD) that are only able to see blurry images on the VR headset, or children showing signs of undue neck and upper body strain or fatigue while trying the headset).
• For the main trial only: Prior use of Floreo s products including but not limited to their ADHD cognitive training application.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Daniel S Pine, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan J Persky, Ph.D.

CONTACT

(301) 451-1268; perskys@mail.nih.gov

Daniel S Pine, M.D.

CONTACT

(301) 594-1318; daniel.pine@nih.gov

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 8, 2022
• Study Start: March 15, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11-19

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The timeline for data sharing will follow the NHGRI Genomic Data Sharing Policy. Currently data is deposited following IRB review once the study data collection is complete and the data has undergone quality control steps.
• Access Criteria: Access requests for specific research purposes using NIH controlled-access data are reviewed by NIH Data Access Committees (DACs).

Locations

US (1)