Virtual Reality for ADHD

Recruiting at 2 trial locations

Overseen By Sophia R Frontale, MPS

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Autism, Bipolar, OCD, seizures, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this pilot randomized clinical trial is to test the impact of a virtual reality program for improving the ability of emerging adults (age 18-25) with attention deficit hyperactivity disorder (ADHD) to stay focused while completing homework and studying. This study compares the impact of using a virtual reality headset to using a virtual reality headset while also receiving feedback about levels of focus to a control group. The main question is whether participants demonstrate significantly improved concentration while completing homework and studying in virtual reality and whether they enjoy and prefer working in a virtual reality environment. Concentration is measured both through participant report and also using keyboard and mouse click data to assess work productivity objectively.

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 data supports the effectiveness of the treatment Meta Quest 3 VR Headset for ADHD?

Research shows that virtual reality (VR) treatments can help improve attention and reduce errors in children with ADHD. Studies found that VR-based interventions led to better sustained attention and fewer mistakes, making them a promising tool for managing ADHD symptoms. ^{1 2 3 4 5}

Is virtual reality safe for children with ADHD?

Research shows that virtual reality (VR) is generally safe for children with ADHD, with no reported adverse effects in studies. Participants found VR enjoyable and easy to use, and no simulator sickness was reported. ^{1 3 4 6 7}

How does the Meta Quest 3 VR Headset treatment for ADHD differ from other treatments?

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 and cognitive functions. Unlike traditional methods, this approach provides an immersive experience that can simulate real-world distractions, potentially offering a more engaging and effective way to manage ADHD symptoms. ^{1 3 8 9 10}

Research Team

Joshua M Langberg, PhD

Principal Investigator

Rutgers University

Eligibility Criteria

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

I am between 18 and 25 years old.

Exclusion Criteria

Comorbid presence of autism spectrum disorders

Comorbid presence of bipolar disorder

Comorbid presence of obsessive-compulsive disorder

Trial Timeline

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

Treatment Details

Interventions

• Meta Quest 3 VR Headset (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. United States 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. [2022]

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

Development of Virtual Reality Continuous Performance Test Utilizing Social Cues for Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Immersive virtual reality for improving cognitive deficits in children with ADHD: a systematic review and meta-analysis. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality-Based Interventions for Children and Adolescents with ADHD: A Systematic Review and Meta-Analysis. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Measuring Attentional Distraction in Children With ADHD Using Virtual Reality Technology With Eye-Tracking. [2022]

6. England 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. [2007]

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

Assessment of Boys' Responses to Interpersonal Conflict in Virtual Reality. [2023]

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

Multimodal Virtual Reality-Based Assessment of Adult ADHD: A Feasibility Study in Healthy Subjects. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Distractibility in Attention/Deficit/ Hyperactivity Disorder (ADHD): the virtual reality classroom. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Virtual reality training to enhance behavior and cognitive function among children with attention-deficit/hyperactivity disorder: brief report. [2019]