The Development of a Virtual Reality Program to Improve Attention in Individuals With TBI
Primary Purpose
TBI (Traumatic Brain Injury)
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Executive Function Training (VREFT)
Sponsored by
About this trial
This is an interventional treatment trial for TBI (Traumatic Brain Injury) focused on measuring cognitive rehabilitation, attention, executive function
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
Sites / Locations
- Kessler FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VREFT: Wonderkin Treatment
VREFT: Attention Control
Arm Description
Administered by computer
Administered by computer
Outcomes
Primary Outcome Measures
Total divided attention post-treatment (covarying for baseline performance)
Comparison between treatment and control groups on post-treatment Auditory Consonant Trigrams
Total set-shifting post-treatment (covarying for baseline performance)
Comparison between treatment and control groups on post-treatment Stroop interference
Secondary Outcome Measures
Full Information
NCT ID
NCT03605017
First Posted
June 29, 2018
Last Updated
October 13, 2021
Sponsor
Kessler Foundation
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
1. Study Identification
Unique Protocol Identification Number
NCT03605017
Brief Title
The Development of a Virtual Reality Program to Improve Attention in Individuals With TBI
Official Title
The Development of a Virtual Reality Program to Improve Attention in Individuals With TBI
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 26, 2014 (Actual)
Primary Completion Date
March 26, 2022 (Anticipated)
Study Completion Date
March 26, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI (Traumatic Brain Injury)
Keywords
cognitive rehabilitation, attention, executive function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VREFT: Wonderkin Treatment
Arm Type
Experimental
Arm Description
Administered by computer
Arm Title
VREFT: Attention Control
Arm Type
Active Comparator
Arm Description
Administered by computer
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Executive Function Training (VREFT)
Primary Outcome Measure Information:
Title
Total divided attention post-treatment (covarying for baseline performance)
Description
Comparison between treatment and control groups on post-treatment Auditory Consonant Trigrams
Time Frame
7 weeks (between pre- and post-testing)
Title
Total set-shifting post-treatment (covarying for baseline performance)
Description
Comparison between treatment and control groups on post-treatment Stroop interference
Time Frame
7 weeks (between pre- and post-testing)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Krch, PhD
Phone
973-324-8392
Email
dkrch@kesslerfoundation.org
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Smith, BA
Phone
9733248448
Email
asmith@kesslerfoundation.org
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Krch, PhD
Phone
973-324-8392
Email
dkrch@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Angela Smith, BA
Phone
9733248448
Email
asmith@kesslerfoundation.org
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Development of a Virtual Reality Program to Improve Attention in Individuals With TBI
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