VR-based EF Rehabilitation for Pediatric TBI
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

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 safety
      and efficacy of such interventions remain unavailable. In this study, the investigators will
      conduct a small-scale pilot randomized clinical trial to evaluate the safety and preliminary
      efficacy of a novel virtual reality (VR)-based training program for EF rehabilitation for
      mild complicated to severe childhood TBI. Knowledge from this research will provide empirical
      evidence for a larger-scale RCT after the conclusion of this pilot study, with the aim to
      improve the long-term health and quality of life in children with TBI, as well as promote
      efficiency and effectiveness of future psychological rehabilitation for children with TBI.
    

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, 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.
    

Intervention name(s): VR Executive Functions Training; VR Placebo Game
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Windows 10-based VICT program invites children to rescue an animated character named "Lubdub" from a castle. The program consists of three challenging and child-friendly tasks that correspond to the three core EFs.; In this game, children in the control group will use the VR hand controller to cast different types of spells (bees, bouncy balls, sparkler spells) to objects in the virtual world. Objects in the VR world will all react differently to a spell being cast so as to provide children a relaxing and EF-free gaming experience.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: children; executive function; virtual reality; traumatic brain injury