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History of Changes for Study: NCT02490137
Brain Changes With Game Training in Aging (BrainGame)
Latest version (submitted January 8, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 1, 2015 None (earliest Version on record)
2 October 25, 2016 Study Status
3 January 8, 2019 Recruitment Status, Study Status, Contacts/Locations, Study Design and Study Identification
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Study NCT02490137
Submitted Date:  July 1, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: UWisconsin
Brief Title: Brain Changes With Game Training in Aging (BrainGame)
Official Title: Brain Changes With Game Training in Aging
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2015
Overall Status: Recruiting
Study Start: June 2015
Primary Completion: August 2016 [Anticipated]
Study Completion: August 2017 [Anticipated]
First Submitted: July 1, 2015
First Submitted that
Met QC Criteria:
July 1, 2015
First Posted: July 3, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 1, 2015
Last Update Posted: July 3, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Wisconsin, Madison
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module 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.

Open or close this module Conditions
Conditions: Aging
Dementia
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Game Players
Participants that will play video game
Behavioral: Race Car Video Game
Repeatedly playing a race car video game
No Intervention: Control
No video game experience
Open or close this module Outcome Measures
Primary Outcome Measures:
1. MRI: Mean Diffusivity
[ Time Frame: 1.5-2 hours ]

MRI based Mean Diffusivity changes in brain following playing video game for 90 minutes
Secondary Outcome Measures:
1. MRI: Structural Morphometry
[ Time Frame: 1.5-2 hours ]

Local brain volumetric or shape changes
Open or close this module Eligibility
Minimum Age: 50 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  1. 50-80 years of age
  2. Part of existing aging research sample cohorts at University of Wisconsin - Madison
  3. Successful research MRI study within prior two years
  4. May include participants with
    1. No diagnosed cognitive impairment
    2. amnestic MCI
    3. mild AD (single or multi-domain) with predominant amnesia

Exclusion Criteria:

  1. Contraindications to MRI (see Risks of MRI below)
  2. Significant experience with playing race car video games in previous 2 years.
  3. Severe AD
  4. Lack of capacity as determined by the Capacity Assessment of Understanding questionnaire
  5. Women who may be pregnant
Open or close this module Contacts/Locations
Central Contact Person: Andrew Alexander, Ph.D.
Telephone: 6082658233
Email: alalexander2@wisc.edu
Central Contact Backup: Abigail Freeman
Telephone: 6082651445
Email: aafreeman@wisc.edu
Study Officials: Andrew Alexander, Ph.D.
Principal Investigator
University of Wisconsin, Madison
Locations: United States, Wisconsin
University of Wisconsin - Madison
[Recruiting]
Madison, Wisconsin, United States, 53705
Contact:Contact: Andrew Alexander, Ph.D. 608-265-8233 alalexander2@wisc.edu
Contact:Contact: Abigail Freeman 6082651445 aafreeman@wisc.edu
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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