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

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ClinicalTrials.gov Identifier: NCT03605017
Recruitment Status : Active, not recruiting
First Posted : July 30, 2018
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Denise Krch, 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.

Condition or disease Intervention/treatment Phase
TBI (Traumatic Brain Injury) Behavioral: Virtual Reality Executive Function Training (VREFT) Not Applicable

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. 14 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Development of a Virtual Reality Program to Improve Attention in Individuals With TBI
Actual Study Start Date : March 26, 2014
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 26, 2022

Arm Intervention/treatment
Experimental: VREFT: Wonderkin Treatment
Administered by computer
Behavioral: Virtual Reality Executive Function Training (VREFT)
Active Comparator: VREFT: Attention Control
Administered by computer
Behavioral: Virtual Reality Executive Function Training (VREFT)



Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03605017


Locations
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United States, New Jersey
Kessler Foundation
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Kessler Foundation
National Institute on Disability, Independent Living, and Rehabilitation Research

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Responsible Party: Denise Krch, Research Scientist, Kessler Foundation
ClinicalTrials.gov Identifier: NCT03605017     History of Changes
Other Study ID Numbers: R-820-14
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Denise Krch, Kessler Foundation:
cognitive rehabilitation
attention
executive function

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries