A Phase 1/2 interventional study of Non-adaptive Floreo VR control and Floreo Virtual Reality application in Attention Deficit Hyperactivity Disorder, sponsored by National Institute of Mental Health (NIMH). Recruiting at 1 site in United States. Open to participants aged 8 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by National Institute of Mental Health (NIMH) · Phase 1/2, Interventional, and Treatment
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Among 17 studies in Attention Deficit Disorder with Hyperactivity by National Institute of Mental Health (NIMH) — 5 open to participants now, 5 under way, none of them phase 3. Attention Deficit Disorder with Hyperactivity · National Institute of Mental Health (NIMH).
Among the 17 studies in Attention Deficit Disorder with Hyperactivity by National Institute of Mental Health (NIMH), this one is the only one that started in 2024, is the only one in phase 1/2, and was the 14th registered.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 295 are open to participants now.
Browse Attention Deficit Disorder with Hyperactivity studies →5 of the 17 studies in Attention Deficit Disorder with Hyperactivity by National Institute of Mental Health (NIMH) are open now, in 1 country. Recruiting first, the newest first:
National Institute of Mental Health (NIMH) · Sites in United States
Ages 8–17
National Institute of Mental Health (NIMH) · Sites in United States
Ages 8–13
National Institute of Mental Health (NIMH) · Sites in United States
Ages 10–17 · Healthy volunteers
National Institute of Mental Health (NIMH) · Sites in United States
Ages 6–80
By country, each count listing its studies:
Of the 201 Attention Deficit Disorder with Hyperactivity studies recruiting now, 27 (13%) set no upper age limit and 169 (84%) stop at 75 or younger; 141 take children under 18; 55 take healthy volunteers.
This study: 8 Years to 16 Years · all sexes · no healthy volunteers.
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17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2
First in 1985; this study’s year is marked. 1 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 219 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Median enrollment 103 across the 5 interventional studies, 259 across the 12 observational. Of the 11 that completed or were terminated, 1 (9%) have results posted.
This tab as a report to print or save as PDF → With an account.
National Institute of Mental Health (NIMH) is the lead sponsor of 367 studies on the registry; 45 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 17 studies in Attention Deficit Disorder with Hyperactivity by National Institute of Mental Health (NIMH), from their registry updates:
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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.
Study Description:
This study will be a randomized, double-blind, placebo-controlled trial examining the efficacy of a novel virtual reality (VR) adaptive cognitive training intervention for youth with ADHD in improving symptoms of inattention relative to a non-adaptive training control intervention. Prior to the main randomized trial, a 'proof-of concept' open-label pilot study will assess the safety, tolerability, usability, feasibility, credibility and treatment expectancy of the intervention. It will also provide an initial assessment of the efficacy on the intervention in improving inattention symptoms and neuropsychological performance. When these parameters are met, the pilot will be complete and the RCT will begin.
Objectives:
Primary Objective: Examine the efficacy of the Floreo VR intervention in improving symptoms of inattention in children/adolescents with ADHD.
Secondary Objectives: Examine the efficacy of the VR intervention in improving neuropsychological performance in three cognitive domains pertinent to ADHD.
Pilot Study Objective: Assess the safety, tolerability, usability, feasibility, credibility, and treatment expectancy of the VR intervention. Provide an initial open-label assessment of the efficacy of the intervention.
Endpoints:
Primary Endpoint: The primary endpoint of the main trial is to investigate whether the intervention decreases symptoms of inattention as assessed using the ADHD Rating Scale-5 for Children and Adolescents (ADHD-RS-5).
A secondary aim of the main study is to investigate whether the intervention brings about improvements in performance on three neuropsychological performance indices. These are stop signal reaction time on the Stop Signal task (inhibitory control), visuospatial working memory as determined using mean span on the Dot Matrix task, and the number of correct responses on the NIH Toolbox Pattern Comparison Processing Speed Test. A fourth index, a composite measure of temporal deviation on a Temporal Reproduction task, was included in the Phase I pilot only.
Pilot intervention Endpoints: Responses to structured interview items on safety, tolerability, usability, credibility and treatment expectancy of the intervention. Reports of adverse events will be used to assess safety. Feasibility will be assessed using participation and compliance rates. Usability will also be assessed using a System Usability Scale. Open-label assessments of efficacy will also be performed using the ADHD-RS-5 inattention subscale. Secondary endpoints for the pilot study are the same as for the main study.
The criteria were revised on the registry on Nov 12, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will undergo 20 sessions (about 20 minutes each, no more than one per day) of the adaptive Floreo VR training over four weeks, extendable to six weeks to make up missed sessions. Phase I pilot participants also received this intervention in an open-label design.
Behavioral: Floreo Virtual Reality application
This group will undergo 20 sessions (about 20 minutes each, no more than one per day) of the non-adaptive Floreo VR control training over four weeks, extendable to six weeks to make up missed sessions.
Behavioral: Non-adaptive Floreo VR control
The control intervention uses the same Floreo VR training modules, session schedule, headset, and spaceship themed environment as the active intervention. The only difference is that module difficulty is capped at a low level and does not continue to adapt to the child's performance, so demands remain low throughout training. The control training is also completed at home under the supervision of a parent or caregiver, and the two versions are otherwise indistinguishable to families and study staff.
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, and processing speed). A fourth module targeting temporal processing was used in the Phase I pilot only and is not included in the Phase II trial. 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.
ADHD-RS-5 inattention sub-scale.
The ADHD-RS-5 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.
Time frame: within one month of the end of VR training
Stop signal reaction time on the Stop Signal task (inhibitory control)
Computerized neuropsychological assessment of inhibitory control
Time frame: within one month of the end of VR training
Composite measure of temporal deviation on a temporal reproduction task
Computerized neuropsychological assessment of motor-timing. This measure was collected in the Phase I pilot only and is not administered in the Phase II randomized trial.
Time frame: within one month of the end of VR training
Visuospatial working memory, as determined using mean span on the Dot Matrix task
Computerized neuropsychological assessment of working memory
Time frame: within one month of the end of VR training
Number of correct responses on the NIH Toolbox Pattern Comparison Processing Speed Test.
Computerized neuropsychological assessment of processing speed
Time frame: within one month of the end of VR training
Plan to share: Yes — De-identified data will be placed in NIH-designated repositories in accordance with NIH and NIMH policies and are expected to be submitted to the NIMH Data Archive (NDA). De-identified neuroimaging data may also be deposited in openly accessible repositories such as OpenNeuro. Genomic data, which were collected in the Phase I pilot only, will be shared in controlled-access databases such as dbGaP in accordance with the NIH Genomic Data Sharing Policy. Other databases may be used as approved by NIH for the sharing of de-identified data.
Supporting information: Study protocol
Time frame: The timeline for data sharing will follow NIMH data sharing policies. 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).
Started Mar 2024 (actual). Primary completion is estimated for Sep 2028, 53 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 8, 2026: primary completion Jun 2028 → Sep 2028 and completion Jun 2028 → Nov 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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