← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5-7 weeks

Awards & highlights

VRAM Trial Summary

This trial is investigating whether a virtual reality intervention can help people with developmental delays or behavioral challenges improve their attention in the face of distraction.

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.Check my eligibility

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).See study design

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.

VRAM Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Head Movements

Secondary outcome measures

ADHD:RS 5 - Inattentive scale

Improvement in CGI-S ratings in relation to distractibility

Improvement in distractibility determined by CGI-I

+1 more

Other outcome measures

Parent and child satisfaction

Participation

Percent of children with nausea interference

VRAM 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

911 Previous Clinical Trials

4,709,533 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

2,785 Previous Clinical Trials

2,689,305 Total Patients Enrolled

94 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)

19,995 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

Virtual Reality Attention Management Clinical Trial Eligibility Overview. Trial Name: NCT03221244 — N/A

Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: VR Active Control, VR Treatment

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Virtual Reality Attention Management Highlights & Side Effects. Trial Name: NCT03221244 — N/A

Virtual Reality Attention Management 2023 Treatment Timeline for Medical Study. Trial Name: NCT03221244 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being recruited to participate in this research project?

"Yes, according to clinicaltrials.gov, the trial is currently open for recruitment. Initially posted on June 2nd 2016 and last updated November 3rd 2021, this medical study requires 50 participants across a single location."

Answered by AI

What results are investigators hoping to see from this clinical trial?

"The primary assessment of this trial, which will be monitored over a duration spanning 5-7 weeks, is measuring the decrease in ocular shifts towards distractions and/or shorter fixation spans. Secondary outcomes include ameliorations on the Restricted Academic Situations Test (RAST), decreased off task behavior as rated by CGI-S with scores ranging from -3 to 3, and ratings of inattention through ADHD:RS 5 Inattentive scale."

Answered by AI

Is there an upper age limit for enrolment in this investigative research?

"This medical trial has specific requirements for participants; children aged 8 to 12 are considered eligible. In comparison, 98 trials recruit those below 18 and 28 studies require a patient's age be above 65 years old."

Answered by AI

What criteria must be met for individuals to qualify as participants of this trial?

"This trial is currently seeking fifty children aged between 8 and 12 with attention deficit hyperactivity disorder (ADHD). In order to be eligible, participants must have high scores based on Cognitive Problems/Inattention or DSM-based scales, endorse 4+ symptoms of inattention on a clinical psychiatric interview, possess computer literacy skills, and demonstrate an IQ greater than 80."

Answered by AI

Are participants being accepted for this research study at present?

"Affirmative; the clinical trial is actively searching for suitable patients. The original post date was June 2nd 2016 and the latest update happened on November 3rd 2021, according to data hosted on clinicaltrials.gov"

Answered by AI