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Behavioral Intervention
VR Cognitive Rehabilitation for Pediatric TBI
N/A
Recruiting
Led By Jiabin Shen, PhD
Research Sponsored by University of Massachusetts, Lowell
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with TBI within the past 12 months and under 18 years at the time of injury
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (at recruitment/before intervention), post-intervention (after completion of intervention, up to 2 weeks), follow-up (up to 6 months after completion of intervention)
Awards & highlights
Study Summary
This trial will test whether a VR-based training program can help improve executive function in children who have suffered a moderate to severe TBI.
Who is the study for?
This trial is for children who have had a traumatic brain injury (TBI) within the last year, are fluent in English, and were under 18 when injured. They must not have other conditions that interfere with VR use or be restricted from electronic devices. Kids with post-injury seizures can't join.Check my eligibility
What is being tested?
The study tests a new virtual reality program designed to improve thinking skills after TBI against a placebo VR game. Children will be randomly assigned to either the real training or the placebo, and their progress in executive functions will be compared.See study design
What are the potential side effects?
Since this involves cognitive training via VR, side effects may include dizziness, nausea, eye strain or headaches due to prolonged use of virtual reality equipment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with a traumatic brain injury (TBI) in the last year and was under 18 when injured.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (at recruitment/before intervention), post-intervention (after completion of intervention, up to 2 weeks), follow-up (up to 6 months after completion of intervention)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (at recruitment/before intervention), post-intervention (after completion of intervention, up to 2 weeks), follow-up (up to 6 months after completion of intervention)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Performance-based EF in VR
Secondary outcome measures
Changes in Performance-based EF on Standard Lab Task
Daily EF skills
Health-related quality of life
+1 moreOther outcome measures
Motion Sickness
Perceived Exertion
Perceived VR Experience
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Virtual Reality games for training executive functionsExperimental Treatment1 Intervention
Virtual Reality games for training three core executive functions
Group II: Control VR Game on PlaygroundPlacebo Group1 Intervention
A relaxing virtual reality game for control group to play in VR playground without training their executive functions
Find a Location
Who is running the clinical trial?
University of Massachusetts, LowellLead Sponsor
20 Previous Clinical Trials
10,277 Total Patients Enrolled
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.OTHER
88 Previous Clinical Trials
24,904 Total Patients Enrolled
Spaulding Rehabilitation HospitalOTHER
135 Previous Clinical Trials
11,023 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your score on the Agitated Behavior Scale is less than 28, if the test is available.Other health conditions that make it difficult to take the study drug and participate in the study assessments.I was diagnosed with a traumatic brain injury (TBI) in the last year and was under 18 when injured.You have had seizures after an injury.
Research Study Groups:
This trial has the following groups:- Group 1: Virtual Reality games for training executive functions
- Group 2: Control VR Game on Playground
Awards:
This trial has 0 awards, including: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.
To what extent is the subject sample size being utilized in this research?
"Affirmative. Submitted to clinicaltrials.gov on September 3rd 2021 and last amended on October 31st 2022, this trial is presently looking for participants. 32 individuals are required at 1 medical site."
Answered by AI
Is this experiment currently recruiting participants?
"Per the clinicaltrials.gov data, this trial is actively enrolling patients with its first post dating back to September 3rd 2021 and most recent update published October 31st 2022."
Answered by AI
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