VR Cognitive Rehabiliation for Pediatric TBI

• ClinicalTrials.gov Identifier: NCT04526639
• Recruitment Status: Recruiting
• First Posted: August 26, 2020
• Last Update Posted: August 31, 2023
• Sponsor: University of Massachusetts, Lowell
• Collaborators: Spaulding Rehabilitation Hospital; Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Information provided by (Responsible Party): Jiabin Shen, PhD, University of Massachusetts, Lowell

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
TBI (Traumatic Brain Injury)	Behavioral: Virtual Reality-based Interactive Cognitive Training Program; Behavioral: Placebo Virtual Reality Game	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Virtual Reality-based Rehabilitation for Pediatric TBI (R00 Phase)
• Actual Study Start Date: September 3, 2021
• Estimated Primary Completion Date: August 31, 2024
• Estimated Study Completion Date: August 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Changes in Performance-based EF in VR [ Time Frame: 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) ]
   VR-based EF Assessment Task

Secondary Outcome Measures :

1. Changes in Performance-based EF on Standard Lab Task [ Time Frame: 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) ]
   NIH Toolbox Cognition Battery
2. Report-based EF skills [ Time Frame: Follow-Up (up to 6 months after completion of intervention) ]
   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
3. Daily EF skills [ Time Frame: 30 days between post-intervention assessment and follow-up assessment ]
   Brief Daily Survey on self-reported EF skills using ecological momentary assessment
4. Health-related quality of life [ Time Frame: Follow-Up (up to 6 months after completion of intervention) ]
   23-item PedsQL Generic Core Scales (0-100 after transformation, higher scores indicate better quality of life)

Other Outcome Measures:

1. Motion Sickness [ Time Frame: Post-Intervention, up to 2 weeks ]
   Simulator Sickness Questionnaire, 0-3, higher scores indicate higher levels of motion sickness
2. Perceived Exertion [ Time Frame: Post-Intervention, up to 2 weeks ]
   Borg Perceived Exertion Scale (6-26, higher score indicates greater exertion)
3. Perceived VR Experience [ Time Frame: Post-Intervention, up to 2 weeks ]
   VR User Feedback Survey providing subjective feedback on the VR intervention (1-5, higher scores indicate better VR experience)

Eligibility Criteria

• Ages Eligible for Study: up to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Jiabin Shen, PhD; 978-934-3950; jiabin_shen@uml.edu

Locations

United States, Maryland

Kennedy Krieger Institute; Recruiting

Baltimore, Maryland, United States, 21205

Contact: Tyler Busch BuschTA@kennedykrieger.org

Principal Investigator: Stacy Suskauer, MD

United States, Massachusetts

Spaulding Rehabilitation Hospital; Recruiting

Boston, Massachusetts, United States, 02114

Contact: Susan Quinn, MD 617-573-7000 SSQUINN@mgh.harvard.edu

Sponsors and Collaborators

University of Massachusetts, Lowell

Spaulding Rehabilitation Hospital

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Investigators

• Principal Investigator: Jiabin Shen, PhD; University of Massachusetts, Lowell

More Information

• Responsible Party: Jiabin Shen, PhD, Assistant Professor, Psychology, University of Massachusetts, Lowell
• ClinicalTrials.gov Identifier: NCT04526639
• Other Study ID Numbers: R00HD093814 ( U.S. NIH Grant/Contract )
• First Posted: August 26, 2020
• Last Update Posted: August 31, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• Time Frame: Data will be deposited to NICHD DASH within one year after the acceptance for publication of the main findings.
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries