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: Completed
• 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 (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Kennedy Krieger Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Spaulding Rehabilitation Hospital

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
VR-based EF Assessment Task	Performance-based executive function assessment Task in the virtual reality environment built by the research team. There are three tasks within this measurement, each transformed into a z score and summed up to serve as the total score for this measure. A Z-score of 0 in each task represents the sample mean. Higher values represent a better outcome for this measure.	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
NIH Toolbox Cognition Battery	Performance-based executive functions tested by three tasks in the NIH Toolbox Cognition Battery: Dimensional Change Card Sort Test, List Sorting Working Memory Test, and Flanker Inhibitory Control and Attention Test. Scores of each task were computed as age-corrected standard scores automatically by the iPad app of the NIH Toolbox Cognition Battery. Each age-corrected standard score is a z-score with a mean of 100 and standard deviation of 15. Total scores are the mean of all three task age-corrected standard scores. Higher scores represent better outcomes.	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)
Health-related Quality of Life	23-item PedsQL (Pediatric Quality of Life) Generic Core Scales were designed to measure the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. The current study uses its total scores, which is the sum of all 23 items and ranges from 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

Publications and helpful links

General Publications

• Shen J, Wang Y, Quinn S, Suskauer SJ, Birch J, Busch T, Svingos A, Crawfis R, Yeates KO, Taylor HG. Efficacy of a virtual reality-based cognitive interactive training program for children with traumatic brain injuries: study protocol for a parallel-group randomized controlled trial. Trials. 2024 Mar 13;25(1):185. doi: 10.1186/s13063-024-08049-1.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2021
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): 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): October 16, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

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