Attention Deficit Hyperactivity DisorderPhase 1/2NCT05608434
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
A Phase 1/2 study testing Floreo Virtual Reality application in people with Attention Deficit Hyperactivity Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Floreo Virtual Reality application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2024to 1 Nov 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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. 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 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).
- A score of >12 on the ADHD-RS-5 inattention subscale at the screening/baseline assessment. For participants receiving ADHD medication at the time of assessment, the rating will reflect current (i.e., on-medication) symptom levels.
- 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. Not receiving any other psychotropic medication for at least 30 days prior to baseline assessment.
Who cannot join
- 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.
- 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.
Show all 12Show fewer
- 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: Certain psychotropic medications classes that are likely to interfere with the completion of the intervention are exclusionary: antipsychotics, mood stabilizers (lithium, valproate, lamotrigine, gabapentin). In addition, regular use of any other psychoactive (non-stimulant) medication that, in the opinion of the Investigator, may confound study data or interfere with completion of the intervention is exclusionary. 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 interfere with study procedures
- For the main trial only: Prior use of Floreo's products including but not limited to their ADHD cognitive training application.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
Saadia Choudhury, (301) 437-0489, saadia.choudhury@nih.gov
About this study
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.
Read more
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.
Read the detailed description
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 number of correct responses 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Non-adaptive Floreo VR control, Floreo Virtual Reality application
- Keywords
- Virtual Reality, Smart Games, Neurodevelopmental, fMRI, Cognitive Training, EEG, MEG
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-adaptive Floreo VR controlBehavioural
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 Virtual Reality applicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Floreo VR group | Experimental | 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. Receives: Behavioral: Floreo Virtual Reality application |
| Non-adaptive VR control group | Sham comparator | 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. Receives: Behavioral: Non-adaptive Floreo VR control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within one month of the end of VR training
Secondary outcomes (4)
Stop signal reaction time on the Stop Signal task (inhibitory control)
Computerized neuropsychological assessment of inhibitory control
Measured: within one month of the end of VR training
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.
Measured: within one month of the end of VR training
Number of correct responses on the Dot Matrix task
Computerized neuropsychological assessment of working memory
Measured: 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
Measured: within one month of the end of VR training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start15 Mar 2024
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Daniel S Pine, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608434
- Sponsor's protocol ID
- 10000744
- Other IDs
- 000744-M
- Status last verified
- 6 Oct 2026
- First submitted
- 4 Nov 2022
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 10000744
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Virtual Reality, Smart Games, Neurodevelopmental, fMRI, Cognitive Training, EEG, MEG
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 number of correct responses 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Floreo VR group | Experimental | Behavioral: Floreo Virtual Reality applicationThis 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. |
| Non-adaptive VR control group | Sham comparator | Behavioral: Non-adaptive Floreo VR controlThis 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. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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. 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 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-adaptive Floreo VR controlThe 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. | Behavioural | Non-adaptive VR control group |
| Floreo Virtual Reality applicationFloreo 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. | Behavioural | Floreo VR group |
Primary outcome
ADHD-RS-5 inattention sub-scale.
Time frame: within one month of the end of VR training
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.
4 secondary outcomes
Stop signal reaction time on the Stop Signal task (inhibitory control)
Time frame: within one month of the end of VR training
Temporal deviation on a temporal reproduction task
Time frame: within one month of the end of VR training
Number of correct responses on the Dot Matrix task
Time frame: within one month of the end of VR training
Number of correct responses on the NIH Toolbox Pattern Comparison Processing Speed Test.
Time frame: within one month of the end of VR training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel S Pine, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Floreo Virtual Reality application in people with Attention Deficit Hyperactivity Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saadia A Choudhury ((301) 437-0489, saadia.choudhury@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD-RS-5 inattention sub-scale. (time frame: within one month of the end of VR training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.