Clinical trial NCT03611062: VR-based EF Rehabilitation for Pediatric TBI
Official title: A Pilot Study on Virtual Reality-based Rehabilitation for Children With Traumatic Brain Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: children
executive function
virtual reality
traumatic brain injury
Lead sponsor: University of Massachusetts, Lowell
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-08-02
Enrollment: 27
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Level of Simulator Sickness [Feasibility and Safety]
timeFrame: Post-Intervention, up to 30 minutes after intervention
measure: Level of Physical Fatigability [Feasibility and Safety]
timeFrame: Post-Intervention, up to 30 minutes after intervention
measure: Perceived Virtual Reality Experience [Feasibility]
timeFrame: Post-Intervention, up to 30 minutes after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
citation: Shen J, Lundine JP, Koterba C, Udaipuria S, Busch T, Rausch J, Yeates KO, Crawfis R, Xiang H, Taylor HG. VR-based cognitive rehabilitation for children with traumatic brain injuries: Feasibility and safety. Rehabil Psychol. 2022 Nov;67(4):474-483. doi: 10.1037/rep0000458. Epub 2022 Jul 21.