- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02490137
Brain Changes With Game Training in Aging (BrainGame)
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- University of Wisconsin - Madison
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Game Players
Participants that will play video game
|
Repeatedly playing a race car video game
|
No Intervention: Control
No video game experience
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MRI: Mean Diffusivity
Time Frame: 1.5-2 hours
|
MRI based Mean Diffusivity changes in brain following playing video game for 90 minutes
|
1.5-2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MRI: Structural Morphometry
Time Frame: 1.5-2 hours
|
Local brain volumetric or shape changes
|
1.5-2 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew Alexander, Ph.D., University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-1036
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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