VR Cognitive Rehabiliation for Pediatric TBI

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

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.

Study Overview

• Status: Recruiting
• Conditions: TBI (Traumatic Brain Injury)
• Intervention / Treatment: Behavioral: Virtual Reality-based Interactive Cognitive Training Program; Behavioral: Placebo Virtual Reality Game

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiabin Shen, PhD; Phone Number: 978-934-3950; Email: jiabin_shen@uml.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Kennedy Krieger Institute
      • Contact: Tyler Busch; Email: BuschTA@kennedykrieger.org
      • Principal Investigator: Stacy Suskauer, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Spaulding Rehabilitation Hospital
      • Contact: Susan Quinn, MD; Phone Number: 617-573-7000; Email: SSQUINN@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality games for training executive functions; Virtual Reality games for training three core executive functions	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 Comparator: Control VR Game on Playground; A relaxing virtual reality game for control group to play in VR playground without training their executive functions	Behavioral: Placebo Virtual Reality Game; A virtual playground for control group to interact without training executive functions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motion Sickness	Simulator Sickness Questionnaire, 0-3, higher scores indicate higher levels of motion sickness	Post-Intervention, up to 2 weeks
Perceived Exertion	Borg Perceived Exertion Scale (6-26, higher score indicates greater exertion)	Post-Intervention, up to 2 weeks
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

Collaborators and Investigators

• Sponsor: University of Massachusetts, Lowell
• Collaborators: Spaulding Rehabilitation Hospital; Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Investigators: Principal Investigator: Jiabin Shen, PhD, University of Massachusetts, Lowell

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2021
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: R00HD093814 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified datasets and associated documents will be deposited and made available to the public through NICHD Data and Specimen Hub (DASH). DASH has policies and procedures in place that are fully consistent with the NIH Data Sharing Policies and applicable laws and regulations. The final dataset will include demographic and clinical data associated with the nature and severity of patients' injuries, self/parent-reported psychological and behavioral data, performance data on cognitive outcomes. Submitted data will confirm with relevant data and terminology standards as well as policies at NIH, NICHD, and DASH.
• IPD Sharing Time Frame: Data will be deposited to NICHD DASH within one year after the acceptance for publication of the main findings.
• IPD Sharing Access Criteria: The data will be accessible to the public through NICHD DASH under a carefully-constructed and closely-monitored Data Use Agreement (DUA) following the NICHD DASH DUA template. This will ensure that requesters are (1) committed to using the data shared only for research purposes as approved by the requester's institutional IRB and not to identify any individual participant; (2) committed to securing the data shared using appropriate safety measures and computer technology; (3) committed to not redistribute the shared data to third parties not approved in the DUA, and (4) committed to destroying the data shared after analyses for the intended research are completed, among other measures to ensure the confidentiality of data and protection of subjects' privacy.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No