Virtual Reality Therapy for ADHD

Overseen By Daniel S Pine, M.D.

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: National Institute of Mental Health (NIMH)

Must not be taking: Psychotropics

Disqualifiers: Intellectual disabilities, Epilepsy, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

219 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether virtual reality games, specifically the Floreo Virtual Reality application, can enhance thinking skills and brain function in children diagnosed with ADHD (attention deficit hyperactivity disorder). The games aim to improve focus, memory, and decision-making, which can be challenging for kids with ADHD. Children aged 8 to 16 years who have ADHD and struggle with focusing or controlling their behavior may be suitable candidates. Participants will use a VR headset to play these games in short sessions over several weeks, while researchers monitor changes in cognitive skills and brain activity. As a Phase 1, Phase 2 trial, this study seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

If you are taking psychostimulants for ADHD, you will need to stop taking them three days before the study starts and remain off them until the study ends. You should not be on any other psychotropic medications for at least 30 days before the study begins.

What prior data suggests that this virtual reality therapy is safe for children with ADHD?

Research shows that the Floreo Virtual Reality app is generally safe and easy to use. In past studies with children, Floreo VR helped improve social skills without causing major side effects. Participants in these studies found the technology comfortable and easy to accept.

However, virtual reality is not recommended for people with certain conditions, such as a history of seizures or sensitivity to light. Although no serious issues have been reported, some users might experience motion sickness, eye strain, or headaches. Researchers have checked the safety of Floreo VR for other conditions, but users should pay attention to any discomfort while using the app.

Overall, studies suggest that Floreo VR is a promising tool that is both safe and effective for improving cognitive skills in children with ADHD. Participants should report any side effects to ensure the best experience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Floreo Virtual Reality application for ADHD because it offers a new way to engage users through immersive experiences. Unlike traditional ADHD treatments, which often rely on medications like stimulants to manage symptoms, this VR approach provides a non-pharmacological option that could minimize side effects. The adaptive nature of the Floreo VR application allows it to tailor experiences to individual users, potentially leading to more personalized and effective outcomes. Moreover, the interactive and engaging nature of VR could make therapy more appealing and enjoyable for users, especially children, which may improve adherence and long-term benefits.

What evidence suggests that virtual reality therapy is effective for ADHD?

Research has shown that virtual reality treatments like Floreo VR, which participants in this trial will use, can help improve symptoms of ADHD, such as hyperactivity, impulsivity, and attention difficulties. Studies have found that these VR games can enhance skills like planning and decision-making. In one study, participants using the Floreo VR system demonstrated improved attention and memory. Early findings also suggest that VR games might positively alter brain function, aiding children in managing their ADHD more effectively. Overall, these games could be a promising tool for enhancing cognitive skills in children with ADHD. ^{4 6 7 8 9}

Who Is on the Research Team?

Daniel S Pine, M.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Are You a Good Fit for This Trial?

This trial is for children aged 7 to 14 with ADHD, who can follow the study's procedures and are stable on medication if they're taking any. It excludes those with cognitive impairments, severe migraines, vertigo, epilepsy or serious balance disorders, poor uncorrected vision, pregnancy, psychotic disorders or substance dependence.

Inclusion Criteria

I have been diagnosed with ADHD, mainly inattentive or combined type.

My gender identity or ethnicity does not limit my participation.

Children must provide informed assent and parents must provide informed consent to participate in the study

Exclusion Criteria

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

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pilot Study

Open-label pilot study to assess safety, tolerability, usability, feasibility, credibility, and treatment expectancy of the VR intervention

4 weeks

Weekly interviews (virtual)

Randomized Controlled Trial

Participants are randomly assigned to either the full version or a limited version of the VR games to assess efficacy in improving ADHD symptoms

4 weeks

Weekly interviews (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (telehealth)

What Are the Treatments Tested in This Trial?

Interventions

• Floreo Virtual Reality application
• Floreo Virtual Reality application - non-adaptive

Trial Overview The trial tests a virtual reality-based game using Floreo VR applications designed to improve attention and cognitive skills in kids with ADHD. Participants play games that target specific skills like inhibition control for several weeks while their brain function is monitored.

How Is the Trial Designed?

Group I: Floreo VR group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

National Institute of Mental Health (NIMH)

Lead Sponsor

Trials

3,007

Recruited

2,852,000+

National Human Genome Research Institute (NHGRI)

Lead Sponsor

Trials

273

Recruited

299,000+

Published Research Related to This Trial

Virtual reality technology (VRT) has shown promise in reducing symptoms of mental disorders, supported by both theoretical and empirical research.

However, there are concerns that VRT may also lead to negative psychological effects, highlighting the need for more sophisticated studies to better understand its therapeutic applications and potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychiatric therapeutic applications of virtual reality technology (VRT): research prospectus and phenomenological critique. Bloom, RW.[2005]

In a study involving 19 hospitalized children and adolescents with chronic illnesses, those receiving virtual reality treatment reported significantly higher perceived efficacy and acceptability compared to traditional cognitive-behavioral therapy.

The virtual reality program was well-received, showing high scores in immersion and feasibility, suggesting that technology-based treatments can enhance motivation and engagement in therapeutic settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Emotional Well-being in Hospitalized Children and Adolescents With Virtual Reality: Usability and Acceptability of a Randomized Controlled Trial. Flujas-Contreras, JM., Ruiz-Castañeda, D., Gómez, I.[2021]

A study involving 9 children aged 4 to 6 years with suspected developmental coordination disorder (DCD) showed that using a low-cost virtual reality game in 10 sessions significantly improved their motor function, as indicated by better scores on the Movement Assessment Battery for Children-2 (M-ABC-2).

The children not only demonstrated improved balance and overall movement skills but also appeared motivated and enjoyed the VR experience, suggesting that this intervention could be a fun and effective way to support motor development in young children with DCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-cost virtual reality intervention program for children with developmental coordination disorder: a pilot feasibility study. Ashkenazi, T., Weiss, PL., Orian, D., et al.[2015]

A virtual reality application designed for children with ADHD received high acceptance and usability ratings from 20 clinical experts, indicating it is user-friendly and versatile for addressing the diverse needs of the disorder.

The study also demonstrated that remote evaluation of the VR application was feasible and meaningful, with all experts expressing satisfaction with their experience, suggesting potential for future validation studies with children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An immersive virtual reality-based application for treating ADHD: A remote evaluation of acceptance and usability. Zangiacomi, A., Flori, V., Greci, L., et al.[2022]

The pilot study involving 12 school-aged children with autism demonstrated that Floreo's Joint Attention Module is safe and well-tolerated, with no serious side effects reported and high levels of enjoyment and perceived value from the VR experience.

Preliminary results indicated positive changes in joint attention skills, including increased interactions, eye contact, and initiation of interactions, suggesting that the VR platform may effectively support skill development in children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Support for Joint Attention Using the Floreo Joint Attention Module: Usability and Feasibility Pilot Study. Ravindran, V., Osgood, M., Sazawal, V., et al.[2023]

Immersive virtual reality (VR) training using a head-mounted display (HMD) significantly improved walking speed in patients with multiple sclerosis and stroke compared to conventional treadmill training and semi-immersive VR, indicating its potential effectiveness for gait rehabilitation.

Participants reported higher motivation and preference for the HMD-based training, with no adverse effects like simulator sickness, suggesting that immersive VR could enhance therapy outcomes and patient engagement in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive virtual reality during gait rehabilitation increases walking speed and motivation: a usability evaluation with healthy participants and patients with multiple sclerosis and stroke. Winter, C., Kern, F., Gall, D., et al.[2021]

This trial will evaluate the effectiveness of cognitive behavioral therapy (CBT) combined with adaptive virtual reality (VR) exposure for treating social anxiety disorder (SAD) in 90 participants over 10 weekly sessions, aiming to provide real-time adjustments based on anxiety levels.

The study is designed with high methodological rigor, using a randomized controlled trial format and validated measures, which will help determine if the adaptive VR approach offers significant benefits over traditional CBT methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy with adaptive virtual reality exposure vs. cognitive behavioral therapy with in vivo exposure in the treatment of social anxiety disorder: A study protocol for a randomized controlled trial. Ørskov, PT., Lichtenstein, MB., Ernst, MT., et al.[2022]

A study involving 45 adults with social anxiety disorder (SAD) demonstrated that both traditional cognitive-behavioral therapy (CBT) and a combined CBT with virtual reality (CBT-VR) significantly reduced anxiety levels compared to a waiting list group.

The results indicate that CBT treatments, including innovative approaches like CBT-VR, are effective for managing social anxiety, suggesting that these methods can be beneficial for individuals beyond just fear of public speaking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using virtual humans to alleviate social anxiety: preliminary report from a comparative outcome study. Robillard, G., Bouchard, S., Dumoulin, S., et al.[2019]

This study will compare the effectiveness of traditional one-session exposure therapy (OST) with a new gamified virtual reality (VR) exposure therapy for treating spider phobia in 100 participants, assessing outcomes at multiple time points up to a year after treatment.

The use of VR therapy aims to improve accessibility and engagement in treatment, potentially making it a more effective and acceptable option for individuals reluctant to seek traditional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-session gamified virtual reality exposure therapy for spider phobia vs. traditional exposure therapy: study protocol for a randomized controlled non-inferiority trial. Miloff, A., Lindner, P., Hamilton, W., et al.[2019]

A meta-analysis of 14 clinical trials showed that virtual reality exposure therapy (VRET) significantly improves behavioral assessments in patients with specific phobias, with a strong effect size of g = 1.23 after treatment.

VRET was found to be as effective as traditional in vivo exposure therapy, indicating that it can produce meaningful behavior changes in real-life situations, making it a valuable treatment option for specific phobias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can virtual reality exposure therapy gains be generalized to real-life? A meta-analysis of studies applying behavioral assessments. Morina, N., Ijntema, H., Meyerbröker, K., et al.[2018]

Virtual reality (VR) shows promise as an effective assessment and treatment tool for anxiety disorders, including post-traumatic stress disorder and obsessive-compulsive disorder, but its use in clinical practice remains limited despite rapid advancements in technology.

VR is particularly appealing for younger patients due to its engaging and playful elements, which may facilitate treatment and preventive interventions, highlighting the need for further research and integration into clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of virtual reality in assessment and treatment of anxiety and related disorders. Meyerbröker, K., Morina, N.[2021]

A 6-month trial using a virtual reality tool called IAmHero showed significant improvements in ADHD symptoms, particularly in hyperactivity and impulsivity, among children aged 5 to 12 years.

The VR approach was well-accepted by participants and demonstrated flexibility, suggesting it could be a valuable tool in ADHD rehabilitation, although more research is needed to fully understand its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IAmHero: Preliminary Findings of an Experimental Study to Evaluate the Statistical Significance of an Intervention for ADHD Conducted through the Use of Serious Games in Virtual Reality. Schena, A., Garotti, R., D'Alise, D., et al.[2023]

Citations

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Development of Virtual Reality-based Interventions to Str... Primary Objective: Examine the efficacy of the Floreo VR intervention in improving symptoms of inattention in children/adolescents with ADHD.

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Virtual Reality Support for Joint Attention Using the Floreo ... Overall, 14 Floreo VR Joint Attention Module training sessions were conducted over a 5-week period. Participants attended 80.3% (135/168) of ...

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Research | Floreo Science-based VR Therapy for ... An NIH-funded pilot study investigating outcomes of cognitive training for ADHD using virtual reality-driven gamified training modules. This study is ...

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A Pilot Phase I and Randomized Controlled Phase II Trial Objectives: Primary Objective: Examine the efficacy of the Floreo VR intervention in improving symptoms of inattention in children/adolescents with ADHD.

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Virtual Reality Therapy for ADHD Research shows that virtual reality treatments can improve symptoms of ADHD, such as hyperactivity and impulsivity, and enhance executive functions.

6. floreovr.com floreovr.com/

Floreo | Research-based Virtual Reality Therapy for the ... Floreo VR is an FDA breakthrough designated device for neurodiverse learners of any age and ability. At home or in the office, with just a smartphone or VR ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05608434

NCT05608434 | Development of Virtual Reality-based ... Floreo VR is a novel VR-based cognitive training therapy for ADHD. It incorporates multiple learning modules, each of which targets a neuropsychological domain ...

8. floreovr.com floreovr.com/health-safety

Health & Safety Virtual reality is not recommended for people with certain pre-existing conditions such as a history of seizures or photosensitive response on EEG.

9. medrxiv.org medrxiv.org/content/10.1101/2025.08.28.25334679v1.full-text

Children with Autism using the Floreo Virtual Reality ... The study findings suggest that Floreo's Building Social Connections Module is safe and well-tolerated, and has the potential to enhance social ...