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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03582579
Other study ID # 70869
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 27, 2018
Est. completion date August 2024

Study information

Verified date June 2023
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

Behavioral:
Training in Virtual Reality
Action Video Game Based Training in Virtual Reality
Training on a computer screen
Action Video Game Based Training on a computer screen

Locations

Country Name City State
United States University of Rochester Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
University of Rochester Neurotrainer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 weeks
Primary 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. 6 weeks
Primary 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. 6 weeks
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