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

TBI (Traumatic Brain Injury) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03605017
• Other study ID #: R-820-14
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2014
• Est. completion date: March 26, 2022

Study information

• Verified date: October 2021
• Source: Kessler Foundation
• Contact: Denise Krch, PhD
• Phone: 973-324-8392
• Email: dkrch[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 26, 2022
• Est. primary completion date: March 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• TBI (Traumatic Brain Injury)

Intervention

Behavioral:
• Virtual Reality Executive Function Training (VREFT)

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)