Virtual Reality Therapy for ADHD

(VRAM Trial)

Overseen By Julie B Schweitzer, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: ADHD medications

Disqualifiers: Psychosis, Depression, Autism, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 25

Duration: 5-7 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with ADHD improve focus using virtual reality (VR) technology. Participants will engage in VR sessions simulating a classroom to practice focusing despite distractions. The goal is to determine if repeated exposure to distractions in a controlled setting can reduce susceptibility to distraction in real life. The trial seeks individuals who struggle with inattention and are comfortable using a computer. As an unphased trial, this study offers a unique opportunity to explore innovative VR technology to potentially enhance focus and manage ADHD symptoms.

Will I have to stop taking my current medications?

If you are taking medication for ADHD, you cannot participate in certain parts of the study. The protocol does not specify about other medications, so it's best to discuss with the study team.

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

Research shows that virtual reality (VR) can be safely used for children with ADHD. Studies have explored using VR to help kids improve focus by introducing distractions in a controlled environment. These studies have found no major safety issues.

In VR therapy, children wear a headset to enter a virtual classroom, where they perform tasks like math or memory games while managing distractions. This approach aims to enhance their concentration over time.

Although no serious side effects have been reported, it's important to remember that using VR for ADHD remains relatively new. More studies are needed to fully understand its safety and effectiveness. However, current research suggests it is generally well-tolerated by children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual Reality Attention Management for ADHD because it introduces an innovative way to train attention skills using virtual reality. Unlike traditional ADHD treatments that often involve medication or behavioral therapy, this approach immerses participants in a virtual classroom where they can practice focusing despite distractions. This method is unique because it adapts the level of difficulty based on the user's performance, potentially offering a personalized experience that enhances attention control. By providing a new, engaging, and interactive environment, this VR treatment aims to improve focus more effectively than conventional methods.

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

Research shows that virtual reality (VR) can improve attention in people with ADHD. Studies have found that VR methods effectively increase focus and alertness. This trial will compare two VR approaches: the "VR Treatment" arm, where participants encounter adaptive distractors in a virtual classroom to acclimate to distractions, and the "VR Active Control" arm, where participants experience a virtual classroom without adaptive distractors. Early research also suggests that incorporating rewards in a VR setting can further enhance attention. By mimicking real-life distractions in a controlled manner, VR therapy aims to help people with ADHD manage their attention better in everyday situations. ^{6 7 8 9 10}

Who Is on the Research Team?

Julie B Schweitzer, PhD

Principal Investigator

UC Davis MIND Institute

Are You a Good Fit for This Trial?

This trial is for children with ADHD who often get distracted, have an IQ over 80, and are comfortable using a computer. They must show signs of inattention but can't be on ADHD medication or starting other treatments during the study. Kids with severe depression, autism, psychosis, or sensory impairments that affect task performance cannot participate.

Inclusion Criteria

Significant (T score >= 60) ratings of Cognitive Problems/Inattention or DSM Inattention scale scores on the Conners' Parent or Teacher Rating Scale-3 or Parent ADHD Rating Scale-IV (ADHD-RS)

Endorsement of 4 or more symptoms of inattention on a clinical psychiatric interview (e.g. Parent DISC, DICA, Kiddie-SADS, Mini-KID)

Comfortable using a computer

Exclusion Criteria

I am not taking medication for ADHD currently.

Investigator's opinion that it is not in the subject's best interest to continue

Subject is non-compliant with training schedule

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo VR training sessions in a virtual classroom setting with adaptive or nonadaptive distractors

5-7 weeks

25 sessions (in-home)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

Extension

Participants may continue VR training sessions to further assess long-term effects

10 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Attention Management

Trial Overview

The study tests if virtual reality (VR) can help kids with ADHD focus better by getting them used to distractions in a VR classroom setting. Participants will use either a VR program designed to improve attention (treatment) or another type of VR experience (active control).

How Is the Trial Designed?

Group I: VR Treatment Experimental Treatment 1 Intervention

The "VR distractor condition" is an adaptive training, experimental treatment. Participants will wear a headset VR system programmed to simulate a virtual classroom. They will be asked to perform computer tests of math, attention, or working memory in the virtual reality context. Distractors will be presented intermittently throughout the test session. During training sessions, distractor saliency and frequency will increase or decrease based on performance on the tests. 25 sessions should be completed in approximately 5-7 weeks. In-home VR training sessions will each be about 20-30 minutes in length. The investigators expect a decrease in distraction after adaptive distractor exposure in the VR classroom.

Group II: VR Active Control Active Control 1 Intervention

The "VR classroom with no distractors presented" is an active control group. This group will undergo the same training regimen, only their virtual classroom environment will not contain adaptive distractors. Participants will wear a headset VR system programmed to simulate a virtual classroom. They will be asked to perform computer tests of math, attention, or working memory in the virtual reality context. 25 sessions should be completed in approximately 5-7 weeks. In-home VR training sessions will each be about 20-30 minutes in length. The investigators expect no change in response to distraction in the ADHD group after control exposure to the VR classroom.

Virtual Reality Attention Management is already approved in United States for the following indications:

Approved in United States as Virtual Reality Attention Management for:

• Attention Deficit Hyperactivity Disorder (ADHD)
• Distractibility

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

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]

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]

In a study involving 36 boys aged 7 to 10, children with ADHD showed a significant decline in performance over time in a virtual classroom task, while control children maintained their performance levels.

The virtual reality environment effectively distinguished between the attentional capabilities of ADHD children and controls, correlating well with traditional measures like the Continuous Performance Test (CPT II), highlighting its potential as a reliable assessment tool for ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of time on task on ADHD patient's performances in a virtual classroom. Bioulac, S., Lallemand, S., Rizzo, A., et al.[2012]

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 study involving 94 children with ADHD (26 medicated and 68 unmedicated) and 34 healthy children, unmedicated children with ADHD made more omission errors and had slower reaction times compared to healthy peers, indicating greater challenges in attention.

The use of virtual reality for assessing ADHD symptoms proved effective, as it provided a realistic setting to measure behaviors like omission errors and reaction time variability, which were linked to inattentiveness and hyperactivity ratings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influence of Methylphenidate on Hyperactivity and Attention Deficits in Children With ADHD: A Virtual Classroom Test. Mühlberger, A., Jekel, K., Probst, T., et al.[2020]

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]

In a study involving 115 boys with aggressive behavior problems, using interactive virtual reality alongside Cognitive Behavioral Therapy (CBT) significantly reduced aggressive behaviors compared to standard care and traditional roleplays.

The virtual reality approach not only improved treatment outcomes but also enhanced children's emotional engagement and overall appreciation of the therapy, suggesting it could be a valuable tool in behavioral interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating children's aggressive behavior problems using cognitive behavior therapy with virtual reality: A multicenter randomized controlled trial. Alsem, SC., van Dijk, A., Verhulp, EE., et al.[2023]

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]

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]

Children with ADHD performed worse on all continuous performance tasks (CPTs), including a new virtual reality version (VR-CPT) and the traditional Test of Variables of Attention (TOVA), indicating the VR-CPT's effectiveness in identifying attention deficits.

The VR-CPT not only provided similar diagnostic sensitivity to the TOVA but was also reported to be more enjoyable by participants, suggesting it could be a more engaging tool for assessing ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The utility of a continuous performance test embedded in virtual reality in measuring ADHD-related deficits. Pollak, Y., Weiss, PL., Rizzo, AA., et al.[2015]

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