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

Not Applicable

• Conditions: TBI (Traumatic Brain Injury)
• Interventions: Behavioral: Virtual Reality Executive Function Training (VREFT)

• Registration Number: NCT03605017
• Lead Sponsor: Kessler Foundation

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-03-26
• Study First Submitted: 2018-06-29
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-20
• Primary Completion: 2022-03-26
• Study Completion: 2022-03-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VREFT: Wonderkin Treatment	Virtual Reality Executive Function Training (VREFT)	Administered by computer
VREFT: Attention Control	Virtual Reality Executive Function Training (VREFT)	Administered by computer

Primary Outcome Measures

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

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 East Hanover, New Jersey, United States