VR-based EF Rehabilitation for Pediatric TBI

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, 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, whose impairment is associated with impaired daily EF skills, increased
attention problems, and lower quality-of-life (QoL). The CDC reported to Congress in 2015
that post-TBI cognitive rehabilitation was the No. 1 unmet health care need for children with
TBI. However, evidence-based EF rehabilitation programs are lacking. Although research has
shown that a combination of diverse cognitive interventions may improve children's EF,
clinically adapting and implementing such interventions in the rehabilitation setting is
hampered by limited affordability, accessibility, adherence, and generalizability. Virtual
reality (VR) offers an exciting alternative strategy for EF rehabilitation of childhood TBI
for three reasons. First, VR has the flexibility to offer various EF training activities in a
virtual environment within a restricted physical space. Second, VR can be delivered via
Internet/mobile platforms, allowing children to participate in post-discharge training at
home as needed. Third, unlike traditional computerized training programs, VR can provide
immersive experiences in three dimensions. This may increase adherence to training and foster
greater transfer of learned EF skills to untrained tasks in everyday life. Thus far, rigorous
randomized clinical trials (RCTs) have not been conducted to establish the safety and
efficacy of VR-based EF rehabilitation for childhood TBI.

The overall goal of this pilot project is to assess the feasibility, safety, and preliminary
efficacy of a novel VR-based interactive cognitive training (VICT) program for EF
rehabilitation in children ages 7-17 years with complicated mild to severe TBI. The VICT
program is an integrative hardware and software VR system that trains the three core EFs
within a challenging animated mission. Using a small parallel-group RCT, the study focuses on
refining clinically-appropriate VR research paradigms in pediatric rehabilitation settings
and obtaining feasibility, safety, and preliminary efficacy data on children's EF
improvement. After the conclusion of the present pilot study, the investigators will utilize
the knowledge and skills gained from this phase to conduct a full-scale longitudinal
parallel-group RCT to formally evaluate the VICT program's efficacy.

Specifically, a small parallel-group RCT will be carried out in this study. The investigators
aim to recruit 20-30 children with complicated mild to severe TBI and randomly assign each
participant to either an intervention group (VICT) or a control group (comparable VR game
without EF training). Preliminary efficacy outcomes will be assessed at pre-,
post-intervention, and a follow-up visit up to six months after the post-intervention
assessment.

Aim 1. Refine clinically-appropriate paradigms for VR childhood TBI rehabilitation research.

Aim 2. Explore feasibility, safety and preliminary efficacy of the VICT program. The
feasibility and safety of the VICT program will be examined through both quantitative
measures (adverse events, simulator sickness, and fatigability) and a semi-structured
interview with children, families, and clinicians regarding perceived benefits and
challenges. Preliminary efficacy data will be obtained on core EF, daily EF, attention
problems, and health-related QoL for both groups. These data will then be used in a
conservative way to estimate the effect size of this novel intervention and calculate the
required sample size for future RCTs.

Inclusion Criteria:

1. diagnosed with TBI

2. between 7 to 17 years old (inclusive)

3. lowest post-resuscitation Glasgow Coma Scale (GCS)=13-15 combined with trauma-related
abnormalities on neuroimaging or a depressed skull fracture (complicated mild TBI,
CDC/NIH definition), GCS=9-12 (moderate TBI, CDC/NIH definition), and GCS=3-8 (severe
TBI, CDC/NIH definition)

4. fluent in English-based communication

5. currently score <28 on the Agitated Behavior Scale (ABS), indicating mild to no
agitation.

Exclusion Criteria:

1. severe physical/visual/cognitive comorbidities secondary to TBI that prevent proper
utilization of a VR-based game and valid administration of the study measures

2. premorbid neurological disorder or neurodevelopmental issues prior to injury that
prevent proper utilization of a VR-based game and valid administration of the study
measures

3. patients who are restricted from using electronic gaming devices.