The Development of a Virtual Reality Program to Improve Attention in Individuals With TBI

Study Overview
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Brief Summary
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The purpose of this research is to investigate the effectiveness of a technique designed to improve divided attention and set-shifting impairments in persons with a traumatic brain injury (TBI). The study is designed to evaluate how well this technique can help people with TBI increase their attention and ability to function better in everyday life.

Detailed Description
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A pilot study will be conducted to evaluate the effectiveness of a technique designed to improve higher level attention (switching between tasks and multi-tasking) for persons with a traumatic brain injury. 32 individuals with TBI will be recruited. Baseline assessment includes neuropsychological evaluation using traditional measures as well as a completion of a number of questionnaires designed to measure everyday attention and everyday functioning. Participants are random assigned to either the experimental or control groups. Experimental and control treatments include two 60 minute sessions, twice per week, for 5 weeks. Follow-up assessment includes a neuropsychological evaluation using traditional measures as well as a completion of a number of questionnaires designed to measure everyday attention and everyday functioning. Protocol efficacy will be determined by improvements between baseline and follow-up on several objective and functional measures of divided attention and set-shifting.

Official Title
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The Development of a Virtual Reality Program to Improve Attention in Individuals With TBI

Conditions
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TBI (Traumatic Brain Injury)

Intervention / Treatment
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* Behavioral: Virtual Reality Executive Function Training (VREFT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between the ages of 18-65 diagnosis of TBI can read and speak English fluently Exclusion Criteria: prior stroke or neurological disease other than TBI unstable or uncontrolled seizures currently taking benzodiazepines

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VREFT: Wonderkin Treatment<br>Administered by computer | Behavioral: Virtual Reality Executive Function Training (VREFT)<br> <br> |
| Active Comparator: VREFT: Attention Control<br>Administered by computer | Behavioral: Virtual Reality Executive Function Training (VREFT)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total divided attention post-treatment (covarying for baseline performance) | Comparison between treatment and control groups on post-treatment Auditory Consonant Trigrams | 7 weeks (between pre- and post-testing) | 
| Total set-shifting post-treatment (covarying for baseline performance) | Comparison between treatment and control groups on post-treatment Stroop interference | 7 weeks (between pre- and post-testing) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive rehabilitation, attention, executive function