What side effects are associated with this type of intervention?

The most common treatments for ADHD include stimulant medications like methylphenidate and nonstimulant medications like atomoxetine. Stimulant medications can cause side effects such as increased heart rate, elevated blood pressure, sleep disturbances, and decreased appetite. Nonstimulant medications like atomoxetine generally have fewer adverse effects on sleep but can cause somnolence. Virtual Reality-Based Habituation Training, which involves repeated exposure to distracting stimuli, is being studied as a non-pharmacological intervention to improve attention by reducing physiological and emotional responses to distractions.

What prior FDA approvals exist?

The FDA has approved several treatments for ADHD, including stimulant medications like methylphenidate and dextroamphetamine, which are highly effective for many patients. Additionally, Akili Interactive's EndeavorRx, a video game therapy, has been approved as a treatment regimen for children with ADHD. This is somewhat similar to the Virtual Reality-Based Habituation Training being studied, as both involve digital interventions aimed at improving attention and managing symptoms of ADHD.

What other types of research exist?

Promising, novel alternatives to Virtual Reality-Based Habituation Training for ADHD patients include: 1) Serious videogames, which offer advantages over traditional videogames in engaging ADHD patients. 2) Online chess, which can serve as a cognitive augmentation strategy. 3) Guided imagery, hypnosis, and biofeedback, which are mind-body therapies shown to improve behavior and performance. 4) Light therapy, particularly strategic avoidance of evening light, which has shown benefits in improving sleep and attention in ADHD patients. 5) Dietary supplements such as fish oils and multivitamins, which are marketed for ADHD and have some supportive evidence.

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Virtual Reality Therapy for ADHD (VRAM Trial)

N/A

Recruiting

Led By Julie Schweitzer, PhD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Must not have

Subjects on pharmacotherapy for ADHD at the time of enrollment will be excluded from Aims 3 and 4

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5-7 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial uses virtual reality (VR) therapy to help children with ADHD improve their focus by getting used to distractions. The VR sessions simulate a classroom with various distractions, allowing children to practice ignoring them. The goal is to help these children perform better in real-life situations by reducing their susceptibility to distractions.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Since this trial involves non-invasive VR technology, side effects might include temporary discomfort like dizziness or nausea from using the VR headset. There may also be eye strain or headaches due to screen exposure.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not taking medication for ADHD currently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5-7 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5-7 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-7 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Decrease in the amount of eye movements toward the distractors and/or shorter duration of fixation on distractors.

Head Movements

Secondary study objectives

ADHD:RS 5 - Inattentive scale

Improvement in CGI-S ratings in relation to distractibility

Improvement in distractibility determined by CGI-I

+1 more

Other study objectives

Parent and child satisfaction

Participation

Percent of children with nausea interference

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: VR TreatmentExperimental Treatment1 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 ControlActive Control1 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.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ADHD include stimulant medications like methylphenidate and amphetamines, which increase the levels of neurotransmitters dopamine and norepinephrine in the brain, enhancing focus and attention. Non-stimulant medications, such as atomoxetine, work by selectively inhibiting the reuptake of norepinephrine. Behavioral therapies, including Cognitive Behavioral Therapy (CBT) and Dialectical Behavior Therapy (DBT), help patients develop coping strategies, improve emotional regulation, and reduce impulsive behaviors. These treatments are crucial for ADHD patients as they address core symptoms and improve daily functioning. Virtual Reality-Based Habituation Training, which involves repeated exposure to distracting stimuli, aims to reduce distractibility by habituating patients to potential distractions, thereby enhancing their ability to maintain attention in real-world settings.

Twenty years of research on attention-deficit/hyperactivity disorder (ADHD): looking back, looking forward.