Brain Changes With Game Training in Aging (BrainGame)
Primary Purpose
Aging, Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Race Car Video Game
Sponsored by
About this trial
This is an interventional basic science trial for Aging
Eligibility Criteria
Inclusion Criteria:
- 50-80 years of age
- Part of existing aging research sample cohorts at University of Wisconsin - Madison
- Successful research MRI study within prior two years
May include participants with
- No diagnosed cognitive impairment
- amnestic MCI
- mild AD (single or multi-domain) with predominant amnesia
Exclusion Criteria:
- Contraindications to MRI (see Risks of MRI below)
- Significant experience with playing race car video games in previous 2 years.
- Severe AD
- Lack of capacity as determined by the Capacity Assessment of Understanding questionnaire
- Women who may be pregnant
Sites / Locations
- University of Wisconsin - Madison
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Game Players
Control
Arm Description
Participants that will play video game
No video game experience
Outcomes
Primary Outcome Measures
MRI: Mean Diffusivity
MRI based Mean Diffusivity changes in brain following playing video game for 90 minutes
Secondary Outcome Measures
MRI: Structural Morphometry
Local brain volumetric or shape changes
Full Information
NCT ID
NCT02490137
First Posted
July 1, 2015
Last Updated
January 8, 2019
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT02490137
Brief Title
Brain Changes With Game Training in Aging
Acronym
BrainGame
Official Title
Brain Changes With Game Training in Aging
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2015 (Actual)
Primary Completion Date
August 15, 2017 (Actual)
Study Completion Date
August 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose is to use MRI to investigate brain changes associated with playing a race car video game for 90 minutes in aging adults both with and without early signs of dementia.
Detailed Description
Neuroplasticity is an important process associated with memory and learning, and may be impaired in early Alzheimer's disease (AD). Video games are one potential strategy for investigating adaptive cognitive learning. Recent neuroimaging studies in healthy young adults have been able to detect brain changes associated with learning and memory from a racing video game over relatively short training periods of a couple hours. This strategy offers significant promise for characterizing the potential for neuroplasticity in patients at risk for AD including amnestic mild cognitive impairment (aMCI).
This project will apply video game training with magnetic resonance imaging (MRI) brain scanning to investigate adaptive learning, working memory and neuroplasticity as a function of aging and in patients with aMCI. A total of forty participants will be studied. Twenty subjects will undergo the video game training. Twenty subjects will be passive controls.
Specific Aims:
To characterize the microstructural brain changes after video game training in aging subjects and determine how patients with amnestic MCI (aMCI) and early AD are affected. For this study, adult participants ages 50 and older including patients with aMCI and early AD will undergo two neuroimaging sessions spaced roughly two hours apart that are bracketed around roughly 90 minutes of car racing game play. We will use diffusion-weighted imaging to detect longitudinal changes in microstructure of the hippocampus and parahippocampus. A primary objective of this study is to demonstrate that these training and imaging methods are translatable to patients with MCI. We will investigate the following two important hypotheses.
Hypothesis 1: Following car racing video game play, participants, on average, will demonstrate significant microstructural changes in hippocampal and parahippocampal brain regions measured with MRI.
Hypothesis 2: The microstructural changes in the hippocampus and parahippocampus measured with MRI will be significantly correlated with (a) cognitive memory performance as assessed by recent memory assessments, and (b) improvements in video game performance in all participants.
The primary outcome measures for both Hypotheses are the changes in the MRI measurements following car racing video game play.
A long-term objective of this project is to determine whether imaging short term neuroplasticity is predictive for individual patients of either future conversion to AD or the effectiveness of cognitive training therapies. More generally, neuroimaging markers of learning-induced brain plasticity would provide extremely useful tools for investigations of aging, dementias, and neurodegenerative diseases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Dementia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Game Players
Arm Type
Experimental
Arm Description
Participants that will play video game
Arm Title
Control
Arm Type
No Intervention
Arm Description
No video game experience
Intervention Type
Behavioral
Intervention Name(s)
Race Car Video Game
Intervention Description
Repeatedly playing a race car video game
Primary Outcome Measure Information:
Title
MRI: Mean Diffusivity
Description
MRI based Mean Diffusivity changes in brain following playing video game for 90 minutes
Time Frame
1.5-2 hours
Secondary Outcome Measure Information:
Title
MRI: Structural Morphometry
Description
Local brain volumetric or shape changes
Time Frame
1.5-2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
50-80 years of age
Part of existing aging research sample cohorts at University of Wisconsin - Madison
Successful research MRI study within prior two years
May include participants with
No diagnosed cognitive impairment
amnestic MCI
mild AD (single or multi-domain) with predominant amnesia
Exclusion Criteria:
Contraindications to MRI (see Risks of MRI below)
Significant experience with playing race car video games in previous 2 years.
Severe AD
Lack of capacity as determined by the Capacity Assessment of Understanding questionnaire
Women who may be pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Alexander, Ph.D.
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
12. IPD Sharing Statement
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Brain Changes With Game Training in Aging
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