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Brain Changes With Game Training in Aging (BrainGame)

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ClinicalTrials.gov Identifier: NCT02490137
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE July 1, 2015
First Posted Date  ICMJE July 3, 2015
Last Update Posted Date January 10, 2019
Actual Study Start Date  ICMJE June 15, 2015
Actual Primary Completion Date August 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2015)
MRI: Mean Diffusivity [ Time Frame: 1.5-2 hours ]
MRI based Mean Diffusivity changes in brain following playing video game for 90 minutes
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2015)
MRI: Structural Morphometry [ Time Frame: 1.5-2 hours ]
Local brain volumetric or shape changes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brain Changes With Game Training in Aging
Official Title  ICMJE Brain Changes With Game Training in Aging
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Aging
  • Dementia
Intervention  ICMJE Behavioral: Race Car Video Game
Repeatedly playing a race car video game
Study Arms  ICMJE
  • Experimental: Game Players
    Participants that will play video game
    Intervention: Behavioral: Race Car Video Game
  • No Intervention: Control
    No video game experience
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2019)
20
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2015)
40
Actual Study Completion Date  ICMJE August 15, 2017
Actual Primary Completion Date August 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02490137
Other Study ID Numbers  ICMJE 2014-1036
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Wisconsin, Madison
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Wisconsin, Madison
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Alexander, Ph.D. University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP