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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
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
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 moreOther study objectives
Parent and child satisfaction
Participation
Percent of children with nausea interference
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.
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.
Twenty years of research on attention-deficit/hyperactivity disorder (ADHD): looking back, looking forward.
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Who is running the clinical trial?
University of California, DavisLead Sponsor
934 Previous Clinical Trials
4,719,388 Total Patients Enrolled
7 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
354 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
National Institute of Mental Health (NIMH)NIH
2,886 Previous Clinical Trials
2,721,744 Total Patients Enrolled
95 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
20,020 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Julie Schweitzer, PhDPrincipal InvestigatorUC Davis MIND Institute
2 Previous Clinical Trials
38 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
26 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking medication for ADHD currently.
Research Study Groups:
This trial has the following groups:- Group 1: VR Active Control
- Group 2: VR Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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