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

NCT ID: NCT03605017

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-26

Study Completion Date

2022-03-26

Brief Summary

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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

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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.

Conditions

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TBI (Traumatic Brain Injury)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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VREFT: Wonderkin Treatment

Administered by computer

Group Type EXPERIMENTAL

Virtual Reality Executive Function Training (VREFT)

Intervention Type BEHAVIORAL

VREFT: Attention Control

Administered by computer

Group Type ACTIVE_COMPARATOR

Virtual Reality Executive Function Training (VREFT)

Intervention Type BEHAVIORAL

Interventions

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Virtual Reality Executive Function Training (VREFT)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role collaborator

Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Denise Krch

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kessler Foundation

East Hanover, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Denise Krch, PhD

Role: CONTACT

[email protected]
973-324-8392

Angela Smith, BA

Role: CONTACT

[email protected]
9733248448

Facility Contacts

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Denise Krch, PhD

Role: primary

[email protected]
973-324-8392

Angela Smith, BA

Role: backup

[email protected]
9733248448

Other Identifiers

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R-820-14

Identifier Type: -

Identifier Source: org_study_id