NCT05608434 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
| NCT ID | NCT05608434 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | National Institute of Mental Health (NIMH) |
| Condition | Attention Deficit Hyperactivity Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 219 participants |
| Start Date | 2024-03-15 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 219 participants in total. It began in 2024-03-15 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
* INCLUSION CRITERIA: In order to be eligible to participate, an individual must meet all of the following criteria: 1. Children must provide informed assent and parents must provide informed consent to participate in the study. 2. Any sex assigned at birth, or race/ethnicity. 3. Aged between 8 and 16 years of age, including all months leading up to age 17. 4. 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). 5. Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study. 6. 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. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. 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.) 2. History of severe migraines, vertigo, epilepsy (with the exception of febrile seizures), or serious balance disorders. 3. Impairments in uncorrected visual acuity that would interfere with engagement with the VR training. 4. Known to be pregnant. 5. Psychotic disorders (including schizophrenia, psychosis not otherwise specified), current substance dependence. Other psychiatric disorders elicited on the interview are not considered exclusionary provided that ADHD is considered to be one of the dominant sources of impairment for the child. 6. Considered a suicide risk as determined during the clinical interview at baseline. 7. 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). 8. Recent (within three months) treatment with other cognitive training interventions (e.g., Cogmed) for ADHD. 9. 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). 10. For the main trial only: Certain psychotropic medications classes that are likely to interfere with the completion of the intervention are exclusionary: antipsychotics, mood stabilizers (lithium, valproate, lamotrigine, gabapentin). Medications for ADHD will not be considered as exclusionary. This includes psychostimulants, atomoxetine, alpha 2 adrenergic agonists. Antidepressant and anxiolytic medication will also not be exclusionary if they are deemed not to not interfere with study procedures 11. For the main trial only: Prior use of Floreo s products including but not limited to their ADHD cognitive training application.
Contact & Investigator
Daniel S Pine, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Mental Health (NIMH)
Frequently Asked Questions
Who can join the NCT05608434 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 16 Years, studying Attention Deficit Hyperactivity Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05608434 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05608434 currently recruiting?
Yes, NCT05608434 is actively recruiting participants. Contact the research team at perskys@mail.nih.gov for enrollment information.
Where is the NCT05608434 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT05608434 clinical trial?
NCT05608434 is sponsored by National Institute of Mental Health (NIMH). The principal investigator is Daniel S Pine, M.D. at National Institute of Mental Health (NIMH). The trial plans to enroll 219 participants.