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Clinical Trials/NCT03605017
NCT03605017
Unknown
Not Applicable

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

Kessler Foundation1 site in 1 country32 target enrollmentMarch 26, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
TBI (Traumatic Brain Injury)
Sponsor
Kessler Foundation
Enrollment
32
Locations
1
Primary Endpoint
Total set-shifting post-treatment (covarying for baseline performance)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 26, 2014
End Date
March 26, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kessler Foundation
Responsible Party
Principal Investigator
Principal Investigator

Denise Krch

Research Scientist

Kessler Foundation

Eligibility Criteria

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

Outcomes

Primary Outcomes

Total set-shifting post-treatment (covarying for baseline performance)

Time Frame: 7 weeks (between pre- and post-testing)

Comparison between treatment and control groups on post-treatment Stroop interference

Total divided attention post-treatment (covarying for baseline performance)

Time Frame: 7 weeks (between pre- and post-testing)

Comparison between treatment and control groups on post-treatment Auditory Consonant Trigrams

Study Sites (1)

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