- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03582579
Enhancing Brain Training With Virtual Reality
July 3, 2024 updated by: Duje Tadin, University of Rochester
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14627
- University of Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control in VR
Adults ages 18 to 35 who will be training in Virtual Reality.
|
Action Video Game Based Training in Virtual Reality
|
|
Experimental: Control Non-VR
Adults ages 18 to 35 who will be training on a computer screen.
|
Action Video Game Based Training on a computer screen
|
|
Experimental: College Athletes with TBI Group
Adults ages 18 to 35 with mild TBI who will be training in Virtual Reality
|
Action Video Game Based Training in Virtual Reality
|
|
Experimental: Older Adult Group
Older Adults over the age of 65 who will be training in Virtual Reality
|
Action Video Game Based Training in Virtual Reality
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Crowding (a measure of spacial resolution of attention)
Time Frame: 6 weeks
|
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.
|
6 weeks
|
|
Attentional Blink (a measure of temporal resolution of attention)
Time Frame: 6 weeks
|
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.
|
6 weeks
|
|
Useful Field of View (a measure of spacial awareness)
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Duje Tadin, PhD, University of Rochester
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2018
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
March 20, 2018
First Submitted That Met QC Criteria
June 27, 2018
First Posted (Actual)
July 11, 2018
Study Record Updates
Last Update Posted (Actual)
July 5, 2024
Last Update Submitted That Met QC Criteria
July 3, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 70869
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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