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Enhancing Brain Training With Virtual Reality

Primary Purpose

Mild Traumatic Brain Injury

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training in Virtual Reality
Training on a computer screen
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Traumatic Brain Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

  • Is an adult over the age of 18.
  • Has the capacity to give consent.
  • Has normal or corrected to normal vision.
  • Has adequate hearing.
  • Is a non-action video game player.
  • Is a non-VR game player. All subjects will be assigned to one of four groups: a Control Group training in VR, a Control Groups training on a 2D display, an Older Adult Group without dementia training in VR, and a College Athletes with mild TBI Group training in VR.

Specific Inclusion Criteria for both Control Groups. The subject must:

  • Be between the ages of 18 and 35.
  • Have no neurologic or vascular disorders/injuries.

Specific Inclusion Criteria for the College Athletes with TBI Group. The subject must:

  • Be between the ages of 18 and 35.
  • Be diagnosed with mild TBI (i.e., concussion) within the last two weeks.

Specific Inclusion Criteria for the Older Adult Group. The subject must:

  • Be over the age of 65.
  • Have no neurologic or vascular disorders/injuries.

Exclusion Criteria:

A person will be excluded from the study if he/she:

• Is under the age of 18.

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Control in VR

Control Non-VR

College Athletes with TBI Group

Older Adult Group

Arm Description

Adults ages 18 to 35 who will be training in Virtual Reality.

Adults ages 18 to 35 who will be training on a computer screen.

Adults ages 18 to 35 with mild TBI who will be training in Virtual Reality

Older Adults over the age of 65 who will be training in Virtual Reality

Outcomes

Primary Outcome Measures

Visual Crowding (a measure of spacial resolution of attention)
This is a visual task which will be done an a computer twice. Once prior to the start of training and then again following training. The results (including the number of trials correct as well as the time it took for the subject to respond) will be analyzed and compared across groups.
Attentional Blink (a measure of temporal resolution of attention)
This is a visual task which will be done an a computer twice. Once prior to the start of training and then again following training. The results (including the number of trials correct as well as the time it took for the subject to respond) will be analyzed and compared across groups.
Useful Field of View (a measure of spacial awareness)
This is a visual task which will be done an a computer twice. Once prior to the start of training and then again following training. The results (including the number of trials correct as well as the time it took for the subject to respond) will be analyzed and compared across groups.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2018
Last Updated
June 6, 2023
Sponsor
University of Rochester
Collaborators
Neurotrainer
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1. Study Identification

Unique Protocol Identification Number
NCT03582579
Brief Title
Enhancing Brain Training With Virtual Reality
Official Title
Enhancing Brain Training With Virtual Reality
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 27, 2018 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Neurotrainer

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 study is to evaluate the effectiveness of brain training in a Virtual Reality set up in neurotypical populations as well as in the traumatic brain injury population.
Detailed Description
Brain training is a large and a growing field, both scientifically and commercially. Emerging evidence demonstrates that training can promote beneficial brain plasticity in both healthy individuals and clinical populations. Much of the recent interest in brain training can be traced back to the seminal work done at the University of Rochester, where Daphne Bavelier and colleagues showed that training with action video games (AVG) can lead to a wide range of cognitive and perceptual improvements. In our recent work, we developed a novel training paradigm that isolates and concentrates the key aspects of AVG-training while eliminating complex and often violent gameplay associated with AVGs. The results revealed similarly broad effects of training as with conventional AVGs. In this study, we aim to move this training paradigm to virtual reality (VR) and extend its application to cognitive aging and mild traumatic brain injury (TBI) populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control in VR
Arm Type
Experimental
Arm Description
Adults ages 18 to 35 who will be training in Virtual Reality.
Arm Title
Control Non-VR
Arm Type
Experimental
Arm Description
Adults ages 18 to 35 who will be training on a computer screen.
Arm Title
College Athletes with TBI Group
Arm Type
Experimental
Arm Description
Adults ages 18 to 35 with mild TBI who will be training in Virtual Reality
Arm Title
Older Adult Group
Arm Type
Experimental
Arm Description
Older Adults over the age of 65 who will be training in Virtual Reality
Intervention Type
Behavioral
Intervention Name(s)
Training in Virtual Reality
Intervention Description
Action Video Game Based Training in Virtual Reality
Intervention Type
Behavioral
Intervention Name(s)
Training on a computer screen
Intervention Description
Action Video Game Based Training on a computer screen
Primary Outcome Measure Information:
Title
Visual Crowding (a measure of spacial resolution of attention)
Description
This is a visual task which will be done an a computer twice. Once prior to the start of training and then again following training. The results (including the number of trials correct as well as the time it took for the subject to respond) will be analyzed and compared across groups.
Time Frame
6 weeks
Title
Attentional Blink (a measure of temporal resolution of attention)
Description
This is a visual task which will be done an a computer twice. Once prior to the start of training and then again following training. The results (including the number of trials correct as well as the time it took for the subject to respond) will be analyzed and compared across groups.
Time Frame
6 weeks
Title
Useful Field of View (a measure of spacial awareness)
Description
This is a visual task which will be done an a computer twice. Once prior to the start of training and then again following training. The results (including the number of trials correct as well as the time it took for the subject to respond) will be analyzed and compared across groups.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A person is eligible for inclusion in the study if he/she: Is an adult over the age of 18. Has the capacity to give consent. Has normal or corrected to normal vision. Has adequate hearing. Is a non-action video game player. Is a non-VR game player. All subjects will be assigned to one of four groups: a Control Group training in VR, a Control Groups training on a 2D display, an Older Adult Group without dementia training in VR, and a College Athletes with mild TBI Group training in VR. Specific Inclusion Criteria for both Control Groups. The subject must: Be between the ages of 18 and 35. Have no neurologic or vascular disorders/injuries. Specific Inclusion Criteria for the College Athletes with TBI Group. The subject must: Be between the ages of 18 and 35. Be diagnosed with mild TBI (i.e., concussion) within the last two weeks. Specific Inclusion Criteria for the Older Adult Group. The subject must: Be over the age of 65. Have no neurologic or vascular disorders/injuries. Exclusion Criteria: A person will be excluded from the study if he/she: • Is under the age of 18.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duje Tadin, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Enhancing Brain Training With Virtual Reality

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