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Virtual Reality Therapy for ADHD
Phase 1 & 2
Recruiting
Led By Wallace P Shaw, M.D.
Research Sponsored by National Human Genome Research Institute (NHGRI)
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 within one month of the end of vr training
Awards & highlights
Study Summary
This trial tests if a virtual reality game can improve thinking and brain function in children with ADHD.
Who is the study for?
This trial is for children aged 7 to 14 with ADHD, who can follow the study's procedures and are stable on medication if they're taking any. It excludes those with cognitive impairments, severe migraines, vertigo, epilepsy or serious balance disorders, poor uncorrected vision, pregnancy, psychotic disorders or substance dependence.Check my eligibility
What is being tested?
The trial tests a virtual reality-based game using Floreo VR applications designed to improve attention and cognitive skills in kids with ADHD. Participants play games that target specific skills like inhibition control for several weeks while their brain function is monitored.See study design
What are the potential side effects?
Potential side effects from participating in this trial include motion sickness, eye strain or headaches as reported by participants during weekly interviews.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within one month of the end of vr training
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within one month of the end of vr training
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ADHD-RS-5 inattention sub-scale.
Secondary outcome measures
Matrix Bands
Number of correct responses on the NIH Toolbox Pattern Comparison Processing Speed Test.
Stop signal reaction time on the Stop Signal task (inhibitory control)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Floreo VR groupExperimental Treatment1 Intervention
This group will undergo up to 20 daily sessions (20 minutes each) of the Floreo VR training.
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Who is running the clinical trial?
National Human Genome Research Institute (NHGRI)Lead Sponsor
263 Previous Clinical Trials
283,913 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
5,672 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Wallace P Shaw, M.D.Principal InvestigatorNational Human Genome Research Institute (NHGRI)
2 Previous Clinical Trials
2,191 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
2,191 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of severe migraines, vertigo, epilepsy, or serious balance disorders.I have been diagnosed with ADHD, mainly inattentive or combined type.My gender identity or ethnicity does not limit my participation.I am between 10 and 16 years old.I am willing to stop ADHD medication 3 days before and during the study, and haven't taken other psych meds for 30 days.I am willing and able to follow the study's requirements and be available for its duration.I am able to understand and follow the study's procedures.
Research Study Groups:
This trial has the following groups:- Group 1: Floreo VR group
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any spots open for new participants in this experiment?
"Clinicaltrials.gov confirms that this trial, which was initially put online on December 6th 2022 and last updated on November 30th 2022, is no longer recruiting patients. That said, there are still 154 other trials actively welcoming candidates at the moment."
Answered by AI
Has the Floreo VR group obtained clearance from the FDA?
"There is existing evidence for Floreo VR's safety, but no data thus far to demonstrate its efficacy. On a scale from 1-3, our team has rated it 2 in terms of risk factor."
Answered by AI
What criteria makes someone an ideal candidate for this research effort?
"This study, which is enrolling 219 patients in total, has set out to include individuals with ADHD aged between 7 and 14 years old."
Answered by AI
Are individuals aged 20 or above eligible for enrollment in this trial?
"This experiment can only be participated in by persons between 7 and 14 years old. There are 107 clinical trials available to minors, while those over 65 have access to 38 different options."
Answered by AI
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