Clinical trial for Attention Deficit Hyperactivity Disorder
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
ClinicalTrials.gov ID: NCT05608434
What this study is testing
- What it's testing
- This study aims to find out if playing specific virtual reality games can improve attention, memory, and brain function in children with ADHD.
- Who it's for
- The study is looking for children aged 8 to 16 who have been diagnosed with ADHD.
- What's involved
- Participants will play three virtual reality games for 20 minutes, five days a week, for four weeks. They will also complete health checks, brain scans, and weekly interviews about how they feel.
- Time commitment
- The main activity lasts four weeks, with a final interview at the end and a possible one-month follow-up visit by video call.
- Phase 2: a mid-size study of how well it works
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 16
You may be able to join if
- 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...
- For the main trial only: A score of \>12 on the ADHD-RS-5 inattention subscale at screening.
You likely can't join if
- Cognitively not capable of performing study procedures. Indications of a lack of cognitive capacity could include a known IQ under 70, or a history...
- 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.
- Psychotic disorders (including schizophrenia, psychosis not otherwise specified), current substance dependence.
- Considered a suicide risk as determined during the clinical interview at baseline.
See the full eligibility 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. For the pilot only, the minimum age was 10 years (i.e., pilot participants were aged 10 to 16 years, including all months leading up to age...
- 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...
- For the main trial only: A score of \>12 on the ADHD-RS-5 inattention subscale at screening. For participants receiving ADHD medication at the time of assessment, the rating will reflect current (i.e., on-medication)...
- Stated willingness to comply with all study procedures and lifestyle considerations, availability for the duration of the study, and ability to travel to the NIH Clinical Center for the scheduled in-person study visits.
- 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.
- 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...
- 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.
- Psychotic disorders (including schizophrenia, psychosis not otherwise specified), current substance dependence.
- 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...
- 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...
- For the main trial only: Prior use of Floreo's products including but not limited to their ADHD cognitive training application.
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 16 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.