The Development of a Virtual Reality Program to Improve Attention in Individuals With TBI
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 26, 2014
CompletedFirst Submitted
Initial submission to the registry
June 29, 2018
CompletedFirst Posted
Study publicly available on registry
July 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2022
CompletedOctober 20, 2021
October 1, 2021
8 years
June 29, 2018
October 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
Study Arms (2)
VREFT: Wonderkin Treatment
EXPERIMENTALAdministered by computer
VREFT: Attention Control
ACTIVE COMPARATORAdministered by computer
Interventions
Eligibility Criteria
You may qualify if:
- between the ages of 18-65
- diagnosis of TBI
- can read and speak English fluently
You may not qualify if:
- prior stroke or neurological disease other than TBI
- unstable or uncontrolled seizures
- currently taking benzodiazepines
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kessler Foundation
East Hanover, New Jersey, 07936, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist
Study Record Dates
First Submitted
June 29, 2018
First Posted
July 30, 2018
Study Start
March 26, 2014
Primary Completion
March 26, 2022
Study Completion
March 26, 2022
Last Updated
October 20, 2021
Record last verified: 2021-10