Virtual Reality Therapy for ADHD

Overseen by Susan Persky, Ph.D.

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: National Human Genome Research Institute (NHGRI)

Must not be taking: Psychotropics

Disqualifiers: Intellectual disabilities, Epilepsy, Psychosis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if virtual reality games can help children with ADHD improve their thinking skills and brain function. Participants will play these games to practice focusing, controlling impulses, processing information quickly, and remembering things better. The goal is to see if these games can make a positive difference in their daily lives.

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 data supports the effectiveness of the treatment Floreo Virtual Reality application for ADHD?

Research shows that virtual reality treatments can improve symptoms of ADHD, such as hyperactivity and impulsivity, and enhance executive functions. Additionally, virtual reality is well-accepted and provides motivational benefits compared to traditional treatments. ^{1 2 3 4 5}

Is virtual reality therapy safe for humans?

Research on virtual reality therapy for various conditions, like social anxiety and phobias, suggests it is generally safe and well-accepted by participants. Studies have shown that it can effectively reduce anxiety and improve therapy outcomes without significant safety concerns. ^{6 7 8 9 10}

How is the Floreo Virtual Reality application treatment for ADHD different from other treatments?

The Floreo Virtual Reality application is unique because it uses immersive digital environments to help children with ADHD improve their attention skills, offering a flexible and engaging approach compared to traditional therapies. This VR treatment is designed to be used remotely, making it accessible even during situations like COVID-19 restrictions, and it has shown promise in improving symptoms and executive functions in children. ^{3 4 5 11 12}

Research Team

Susan Persky, Ph.D.

Principal Investigator

National Human Genome Research Institute (NHGRI)

Eligibility Criteria

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)

Trial Timeline

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)

Treatment Details

Interventions

• Floreo Virtual Reality application (Behavioural Intervention)
• Floreo Virtual Reality application - non-adaptive (Behavioural Intervention)

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.

Participant Groups

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 Human Genome Research Institute (NHGRI)

Lead Sponsor

Trials

273

Recruited

299,000+

Eric Green

National Human Genome Research Institute (NHGRI)

Chief Executive Officer since 2009

MD, PhD

Vence L. Bonham Jr.

National Human Genome Research Institute (NHGRI)

Chief Medical Officer since 2021

JD

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Low-cost virtual reality intervention program for children with developmental coordination disorder: a pilot feasibility study. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

An immersive virtual reality-based application for treating ADHD: A remote evaluation of acceptance and usability. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

5. Switzerland 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. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Using virtual humans to alleviate social anxiety: preliminary report from a comparative outcome study. [2019]

7. England 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Can virtual reality exposure therapy gains be generalized to real-life? A meta-analysis of studies applying behavioral assessments. [2018]

9. Switzerland 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. [2022]

10. England 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. [2019]

11. England pubmed.ncbi.nlm.nih.gov

The use of virtual reality in assessment and treatment of anxiety and related disorders. [2021]

12. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality Support for Joint Attention Using the Floreo Joint Attention Module: Usability and Feasibility Pilot Study. [2023]