VR Cognitive Rehabiliation for Pediatric TBI

TBI (Traumatic Brain Injury) Clinical Trial

Official title:

Virtual Reality-based Rehabilitation for Pediatric TBI (R00 Phase)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04526639
• Other study ID #: R00HD093814
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: August 2023
• Source: University of Massachusetts, Lowell
• Contact: Jiabin Shen, PhD
• Phone: 978-934-3950
• Email: jiabin_shen[@]uml.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Childhood traumatic brain injury (TBI) poses significant impairment in children's executive functions (EFs) for moderate to severe injuries, yet interventions specifically designed for children's EF rehabilitation post-TBI and rigorous clinical trials to establish the efficacy of such interventions remain unavailable. In this study, the investigators will conduct a randomized clinical trial to evaluate the efficacy of a novel virtual reality (VR)-based training program for EF rehabilitation for childhood TBI.

Description:

Traumatic brain injury (TBI) is a leading cause of acquired disability in U.S. children, with an estimated 700,000 cases every year, presenting in 75% of children with trauma and accounting for 70% of deaths from childhood trauma. Childhood TBIs often result in significant impairment in cognitive functions,1 particularly in core executive functions (EFs) due to the vulnerability of the frontal lobes, especially after a moderate to severe TBI. Core EF is composed of three skills: inhibitory control, working memory, and cognitive flexibility. These skills are associated with impaired EF behaviors, increased attention problems, and lower health-related quality-of-life (HRQOL). However, evidence-based EF rehabilitation programs are lacking. Although a combination of diverse cognitive interventions may improve children's EF, limited affordability, accessibility, adherence, and generalizability hamper clinically adapting and implementing such interventions in the rehabilitation setting. Virtual reality (VR) offers an exciting alternative strategy for EF rehabilitation of childhood TBI due to its flexibility, accessibility, and immersive experiences in three dimensions. These properties may increase adherence to training and foster an enhanced transfer of learned EF skills to untrained tasks in everyday life. Thus far, rigor-ous randomized clinical trials (RCTs) have not been conducted to establish the efficacy of VR-based EF reha-bilitation for childhood TBI.

The overall goal of the project is to assess the efficacy of a novel VR-based interactive cognitive training (VICT) program for EF rehabilitation in children with TBI with the following aims:

Aim 1. Examine VICT's efficacy in improving core and daily EF skills among children with TBI.

Hypothesis 1.1: Children in the intervention group will show enhanced improvement over controls in trained VR-based EF tasks and untrained NIH Toolbox tasks from baseline to post-intervention and follow-up visits; Hypothesis 1.2: The intervention group will show better reported daily EF than controls at the follow-up visit; Hypothesis 1.3: Children in the intervention group will show faster improvement than controls in daily-reported EF skills between post-intervention and follow-up visits.

Aim 2. Examine VICT's efficacy in reducing attentional problems among children with TBI.

Hypothesis 2.1: Children in the intervention group will show a greater reduction in attentional problems as measured by testing on the Conners Continuous Performance Test 3rd Edition™ (Conners CPT 3TM) from baseline to the post-intervention and follow-up visits than controls; Hypothesis 2.2: Children in the intervention group will show fewer everyday attentional problems on the Be-havior Assessment System for Children 3rd Ed (BASC-3) self- and parent-ratings of attention at the follow-up visit than controls; Hypothesis 2.3: The direct effect of the VICT program in reducing attention problems will be mediated by children's EF behaviors as measured by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2) at the follow-up visit.

Aim 3. Examine VICT's efficacy in improving HRQOL among children with TBI. Hypothesis 3.1:

The intervention group will show higher levels of reported HRQOL than controls at follow-up; Hypothesis 3.2: The direct effect of the VICT program on HRQOL at follow-up will be mediated by children's EF skills and ratings of EF behaviors and attention at the post-intervention and follow-up visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

1. diagnosed with TBI within the past 12 months and under 18 years at the time of injury;

2. fluent in English; and 3) Score <28 on the Agitated Behavior Scale (if available).

Exclusion Criteria:

1. comorbidities or premorbid disorders that prevent proper administration of VR and study measures,

2. restriction from using electronic devices,

3. post-injury seizure activity.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• TBI (Traumatic Brain Injury)

Intervention

Behavioral:
• Virtual Reality-based Interactive Cognitive Training Program
Three virtual reality-based games designed to train inhibitory control, working memory, and cognitive flexibility among children with TBI
• Placebo Virtual Reality Game
A virtual playground for control group to interact without training executive functions

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
University of Massachusetts, Lowell	Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Motion Sickness	Simulator Sickness Questionnaire, 0-3, higher scores indicate higher levels of motion sickness	Post-Intervention, up to 2 weeks
Other	Perceived Exertion	Borg Perceived Exertion Scale (6-26, higher score indicates greater exertion)	Post-Intervention, up to 2 weeks
Other	Perceived VR Experience	VR User Feedback Survey providing subjective feedback on the VR intervention (1-5, higher scores indicate better VR experience)	Post-Intervention, up to 2 weeks
Primary	Changes in Performance-based EF in VR	VR-based EF Assessment Task	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)
Secondary	Changes in Performance-based EF on Standard Lab Task	NIH Toolbox Cognition Battery	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)
Secondary	Report-based EF skills	Behavior Rating Inventory of Executive Function 2; T scores are used (M = 50, SD = 10, no lower/upper limit), T scores from 60 to 64 are considered mildly elevated, and T scores from 65 to 69 are considered potentially clinically elevated. T scores at or above 70 are considered clinically elevated	Follow-Up (up to 6 months after completion of intervention)
Secondary	Daily EF skills	Brief Daily Survey on self-reported EF skills using ecological momentary assessment	30 days between post-intervention assessment and follow-up assessment
Secondary	Health-related quality of life	23-item PedsQL Generic Core Scales (0-100 after transformation, higher scores indicate better quality of life)	Follow-Up (up to 6 months after completion of intervention)