Virtual Reality for ADHD

Not currently recruiting at 2 trial locations

Overseen By Sophia R Frontale, MPS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Autism, Bipolar, OCD, seizures, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual reality can help young adults with ADHD (a condition affecting attention and focus) improve concentration during homework and study sessions. Participants will use a Meta Quest 3 VR headset and be divided into groups: one group will use the headset alone, another will use it in a virtual cabin, and a third will receive focus feedback through a stoplight system in the virtual environment. The trial aims to determine if VR can make focusing easier and more enjoyable. It targets young adults diagnosed with ADHD who struggle to concentrate on homework tasks. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to innovative ADHD solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to consult with the trial coordinators for specific guidance.

What prior data suggests that this virtual reality program is safe for improving focus in emerging adults with ADHD?

Research shows that using virtual reality (VR) headsets like the Meta Quest 3 is generally safe for most people. However, some important safety tips should be kept in mind. Pregnant individuals, the elderly, or those with certain vision or mental health issues should consult a doctor before using VR.

While most people handle VR well, some might experience mild side effects like dizziness, nausea, or headaches, which usually subside after stopping use. Taking breaks and ensuring a safe play area can help prevent accidents.

Overall, the Meta Quest 3 is designed with safety in mind and includes detailed instructions to help users avoid problems, ensuring a safe and comfortable VR experience. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using virtual reality (VR) for ADHD treatment because it offers a novel, immersive approach that traditional methods, like medication and behavioral therapy, don't provide. Unlike the standard treatments that often involve taking pills or attending therapy sessions, this VR approach uses a Meta Quest 3 headset to create a virtual environment where users can practice focusing and maintaining attention. One unique feature is the "Virtual Reality + Feedback" arm, where participants receive real-time feedback on their focus through a stoplight system, helping them self-regulate their attention in a fun and engaging way. This innovative use of technology could transform ADHD treatment by making it more interactive and personalized.

What evidence suggests that this trial's virtual reality treatments could be effective for ADHD?

Research shows that virtual reality (VR) can help manage ADHD symptoms. Studies have found that VR can greatly improve attention by creating lifelike settings that enhance focus. One study discovered that VR-based training, which combines various activities and rewards, improved attention in people with ADHD.

In this trial, participants will experience different VR conditions. One group will use the VR headset in a virtual environment resembling a cabin room, while another group will receive additional feedback on their focus through a stoplight system in the virtual world. This feedback approach, which informs users about their focus levels, has been studied for its potential to boost concentration and productivity. Although more research is needed, early results suggest that VR, especially with feedback, could be a promising tool for helping those with ADHD focus on tasks like studying. ^{3 6 7 8 9}

Who Is on the Research Team?

Joshua M Langberg, PhD

Principal Investigator

Rutgers University

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-25 with ADHD. Participants should be currently enrolled in an educational program and have regular homework or study tasks. They must not have any conditions that would interfere with VR headset use, such as severe motion sickness or epilepsy.

Inclusion Criteria

I experience at least 5 symptoms of ADHD that affect my daily life.

Participants must meet DSM-5 criteria for ADHD

Participants must have an item mean score of >2.0 (often or very often) on the homework task specific version of the Adult Concentration Index (ACI)

Exclusion Criteria

Comorbid presence of autism spectrum disorders

Comorbid presence of bipolar disorder

Comorbid presence of obsessive-compulsive disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline

Participants complete a 2-session baseline where they complete homework and study without using the VR headset

1 week

2 sessions

Treatment

Participants use the VR headset in their room/home or the library 10 times over two weeks for 1-hour sessions each time

2 weeks

10 sessions

Follow-up

Participants are monitored for concentration, effort, and motivation, and answer questions about VR feasibility, usability, and acceptability

1-1.5 months

What Are the Treatments Tested in This Trial?

Interventions

• Meta Quest 3 VR Headset

Trial Overview The trial is testing a virtual reality program using the Meta Quest 3 VR Headset to improve focus during homework and studying for those with ADHD. It compares three groups: one using just the VR headset, another using the VR headset plus feedback on their focus levels, and a control group without these interventions.

How Is the Trial Designed?

Group I: Virtual Reality + Feedback Experimental Treatment 1 Intervention

Participants in this condition wear the virtual reality headset. They are emersed in a virtual world that looks like a cabin room with windows. They are sitting at a desk and can see their laptop screen as part of the virtual world. The program tracks their keyboard and mouse click data to assess how consistently they are working. A stoplight in the virtual environment is green when they are working consistently and turns red when the not.

Group II: Virtual Reality Experimental Treatment 1 Intervention

Participants in this condition wear the virtual reality headset. They are emersed in a virtual world that looks like a cabin room with windows. They are sitting at a desk and can see their laptop screen as part of the virtual world.

Group III: VR Passthrough Active Control 1 Intervention

Participants in this condition wear the same VR headset as participants in the in the other arms. However, they see directly through to their laptop and are not emersed in the virtual world.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Louisiana State University Health Sciences Center in New Orleans

Collaborator

Trials

123

Recruited

42,400+

Published Research Related to This Trial

The study developed a Virtual Seminar Room (VSR) to assess ADHD symptoms in adults using virtual reality, demonstrating its feasibility with 35 healthy participants performing a continuous performance task under distractions.

Results showed that while task performance remained stable, increased head movements and changes in EEG activity indicated varying levels of attention and distraction, suggesting that VR could provide a more ecologically valid assessment of ADHD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Virtual Reality-Based Assessment of Adult ADHD: A Feasibility Study in Healthy Subjects. Wiebe, A., Kannen, K., Li, M., et al.[2023]

In a study involving 19 boys with ADHD and 16 controls, children with ADHD showed significantly more difficulties with attention and hyperactivity in a virtual reality classroom setting compared to their peers, indicating that VR can effectively highlight these challenges.

The virtual reality continuous performance task (CPT) was more effective in classifying ADHD symptoms, achieving an 87.5% classification rate compared to 68.8% with a standard CPT, suggesting that VR environments may better simulate real-world distractions for assessing ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distractibility in Attention/Deficit/ Hyperactivity Disorder (ADHD): the virtual reality classroom. Adams, R., Finn, P., Moes, E., et al.[2015]

In a pilot study involving 20 boys (10 with ADHD and 10 controls), children with ADHD showed significantly more errors and body movement in a virtual reality classroom, indicating challenges in attention performance compared to their peers.

The virtual reality classroom effectively highlighted the impact of distractions on children with ADHD, suggesting it could be a useful tool for assessing attention in a realistic setting, without causing simulator sickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled clinical comparison of attention performance in children with ADHD in a virtual reality classroom compared to standard neuropsychological methods. Parsons, TD., Bowerly, T., Buckwalter, JG., et al.[2007]

A study involving 14 non-medicated children with ADHD showed that 18 sessions of virtual reality-enhanced treadmill training over 6 weeks led to significant improvements in social problems and psychosomatic behavior, as reported by parents.

Post-training assessments indicated enhanced executive function and memory, along with improved gait regularity during dual-task walking, suggesting that this combined motor-cognitive training could be a promising intervention for children with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality training to enhance behavior and cognitive function among children with attention-deficit/hyperactivity disorder: brief report. Shema-Shiratzky, S., Brozgol, M., Cornejo-Thumm, P., et al.[2019]

A systematic review and meta-analysis of four studies involving 125 children with ADHD found that virtual reality-based interventions significantly improve sustained attention, with large effect sizes for omissions and correct hits.

While VR interventions showed promise in enhancing attentional vigilance, they did not lead to improvements in impulsivity, indicating that while effective for certain cognitive deficits, their impact may be limited in other areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality-Based Interventions for Children and Adolescents with ADHD: A Systematic Review and Meta-Analysis. Romero-Ayuso, D., Toledano-González, A., Rodríguez-Martínez, MDC., et al.[2021]

In a study involving 40 students (21 with ADHD and 19 controls), children with ADHD performed similarly to their peers when distractions were present in a virtual reality (VR) environment, but struggled more in a no-distractor setting.

The results suggest that children with ADHD are more sensitive to low-level stimulation, as indicated by increased head movement and poorer performance without distractions, highlighting the potential of VR as a tool for studying attention in ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Distractors on Sustained Attention and Hyperactivity in Youth With Attention Deficit Hyperactivity Disorder Using a Mobile Virtual Reality School Program. Hong, N., Kim, JJ., Kwon, JH., et al.[2022]

The VR continuous performance test (VR-CPT) effectively measures attention in children with ADHD and typically developing children, showing significant associations between ADHD symptoms and performance metrics like omission errors and reaction time.

Incorporating social cues, such as a virtual teacher, into the VR environment may enhance attention performance in children with ADHD, suggesting that these elements can positively influence their engagement and focus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Virtual Reality Continuous Performance Test Utilizing Social Cues for Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. Eom, H., Kim, KK., Lee, S., et al.[2019]

Immersive virtual reality (VR) interventions show large effect sizes in improving cognitive functioning, attention, and memory in children with ADHD, based on a meta-analysis of seven randomized controlled trials.

The study found no significant adverse effects or differences in treatment adherence between VR and control groups, although the overall quality of the included studies was poor and sample sizes were small.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive virtual reality for improving cognitive deficits in children with ADHD: a systematic review and meta-analysis. Corrigan, N., Păsărelu, CR., Voinescu, A.[2023]

The study involved 36 boys aged 8-13 and demonstrated that a virtual reality (VR) headset was enjoyable and easy to use, indicating its potential as a tool for assessing childhood behavior problems.

Participants with more conduct problems perceived virtual characters as meaner, suggesting that VR can effectively engage children in assessing social-cognitive deficits, although it did not correlate with traditional measures of hostile attribution bias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Boys' Responses to Interpersonal Conflict in Virtual Reality. Hummer, TA., Wood, ZM., Miller, K., et al.[2023]

In a study involving 20 children with ADHD, eye-tracking in a virtual reality classroom revealed that distractions significantly disrupted their ability to focus on relevant tasks, even if they did not look at the distractions for long periods.

The use of virtual reality combined with eye-tracking offers a promising method to better understand attentional impairments in real-life settings, which could help in developing more effective interventions for children with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Attentional Distraction in Children With ADHD Using Virtual Reality Technology With Eye-Tracking. Stokes, JD., Rizzo, A., Geng, JJ., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06454604

Virtual Reality Treatment for Emerging Adults With ADHD Behavioral : Meta Quest 3 VR Headset with noise cancelling headphones. Wearing the headset and headphones removes all outside audio and visual distractions.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12541263/

Virtual Reality–Based Assessment of Attention-Deficit ... Objective. This study examines the use of VR-based movement data to operationalize core ADHD symptoms (hyperactivity and inattention) and ...

3. pediatrics.jmir.org pediatrics.jmir.org/2025/1/e66617

Effectiveness of Virtual Reality–Based Cognitive Control ... A recent study combining material and psychological rewards within a VR platform showed that this approach effectively improves attention- ...

4. withpower.com withpower.com/trial/virtual-reality-for-adhd-5af7d

Virtual Reality for ADHD · Info for Participants The Meta Quest 3 VR Headset treatment for ADHD is unique because it uses virtual reality to create realistic environments that help assess and improve attention ...

5. sciencedirect.com sciencedirect.com/org/science/article/pii/S2561672225000859

Effectiveness of Virtual Reality–Based Cognitive Control ... Research has demonstrated that VR technology provides significant benefits in mental health management for adolescents experiencing various ...

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Health And Safety Warnings | Meta Quest 3 Consult a doctor before using your Meta Quest if you are pregnant, elderly, have pre-existing binocular vision abnormalities or psychiatric disorders, or have a ...

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Meta Quest Safety Center: VR Safety Guidelines Find safety guidelines and information on all Meta Quest VR headsets on Meta Quest's Safety Center. Learn how to stay safe while using your Meta VR ...

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Meta Quest 3 Safety Hub: Manual & Guides Protecting yourself. To stay safe in VR, take time to review the health and safety information for your device.

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Health And Safety Warnings | Meta Quest *Batman: Arkham Shadow is rated Teen with violence, mild blood and language. Offer valid on Qualifying Products purchased from September 25, 2024 through ...