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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)

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.
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.
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 below
Select...
I was diagnosed with a traumatic brain injury (TBI) in the last year and was under 18 when injured.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow-up (up to 6 months after completion of intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and follow-up (up to 6 months after completion of intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in Performance-based EF in VR
Secondary study objectives
Changes in Performance-based EF on Standard Lab Task
Daily EF skills
Health-related quality of life
+1 more
Other study objectives
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
89 Previous Clinical Trials
24,831 Total Patients Enrolled
Spaulding Rehabilitation HospitalOTHER
139 Previous Clinical Trials
11,069 Total Patients Enrolled

Media Library

Virtual Reality-based Interactive Cognitive Training Program (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04526639 — N/A
Traumatic Brain Injury Research Study Groups: Virtual Reality games for training executive functions, Control VR Game on Playground
Traumatic Brain Injury Clinical Trial 2023: Virtual Reality-based Interactive Cognitive Training Program Highlights & Side Effects. Trial Name: NCT04526639 — N/A
Virtual Reality-based Interactive Cognitive Training Program (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04526639 — N/A
~8 spots leftby Nov 2025
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