- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03605017
The Development of a Virtual Reality Program to Improve Attention in Individuals With TBI
October 13, 2021 updated by: Denise Krch, Kessler Foundation
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Angela Smith, BA
- Phone Number: 9733248448
- Email: asmith@kesslerfoundation.org
Study Locations
-
-
New Jersey
-
East Hanover, New Jersey, United States, 07936
- Recruiting
- Kessler Foundation
-
Contact:
- Angela Smith, BA
- Phone Number: 9733248448
- Email: asmith@kesslerfoundation.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VREFT: Wonderkin Treatment
Administered by computer
|
|
Active Comparator: VREFT: Attention Control
Administered by computer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
7 weeks (between pre- and post-testing)
|
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
|
7 weeks (between pre- and post-testing)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 26, 2014
Primary Completion (Anticipated)
March 26, 2022
Study Completion (Anticipated)
March 26, 2022
Study Registration Dates
First Submitted
June 29, 2018
First Submitted That Met QC Criteria
July 19, 2018
First Posted (Actual)
July 30, 2018
Study Record Updates
Last Update Posted (Actual)
October 20, 2021
Last Update Submitted That Met QC Criteria
October 13, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-820-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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