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Aging and Cortical Excitability (ACE)

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ClinicalTrials.gov Identifier: NCT03750903
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The objective of the current proposal is to identify 1) how aging-related changes in GABAergic cortical inhibition affect motor performance, and 2) how aerobic exercise may improve inhibitory function and facilitate motor learning.

Condition or disease Intervention/treatment Phase
Aging Behavioral: Aerobic Exercise Behavioral: Stretching and Balance Training Phase 1

Detailed Description:
The current proposal seeks quantify neural inhibition using magnetic resonance spectroscopy (MRS) and transcranial magnetic stimulation (TMS) in older Veterans to identify how each measures contributes to aging-related changes in motor performance. Currently, over 56% (11.8 million) of Veterans are over age 60. Recent research has shown that aging is associated with decreased cortical inhibition and impaired hand motor function. However, this loss of inhibition is not an inescapable consequence of aging. The investigators' previous work that healthy older adults who engage in regular physical activity show increased cortical inhibition and improved dexterity as compared to their sedentary age cohort. This indicates that aerobic training may reverse aging related changes in cortical inhibition and alteration of tonic levels of cortical excitability can have a powerful impact on motor performance in the aging brain. In the current proposal, the investigators will enroll older adults to assess how different measurements (TMS and MRS) of the dominant inhibitory neurotransmitter in the brain - GABA differ in relation to motor control. During the MRS scan, participants will perform a motor learning task to assess change in GABA level throughout the acquisition session. These data will be compared with measures of cortical inhibition using TMS to quantify neurotransmitter receptor activity with respect to aging-related changes in motor performance. The investigators will also be comparing the effects of an aerobic exercise intervention as compared to a contact matched stretching control. The investigators believe this project is the first inquiry of its kind and will have an important impact in the understanding of aging-related neurophysiological changes in the brain and how it can remediate associated behavioral declines.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two group parallel design
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Aging on Cortical Excitability During Motor Learning
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic Exercise
Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.
Behavioral: Aerobic Exercise
Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.
Other Name: AE; Exercise

Active Comparator: Stretching and Balance Training
Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.
Behavioral: Stretching and Balance Training
Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.
Other Name: BAL; Balance




Primary Outcome Measures :
  1. Magnetic Resonance Spectroscopy [ Time Frame: Pre/Post 12 week intervention ]
    Measuring changes in dynamic magnetic resonance spectroscopy of primary motor cortex during motor learning.


Secondary Outcome Measures :
  1. Transcranial Magnetic Stimulation [ Time Frame: Pre/Post 12 week intervention ]
    Measure changes in TMS measures of cortical excitability pre/post intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • living persons aged 50-85

Exclusion Criteria:

  • unmanaged diabetes
  • participants completing vigorous exercise per week
  • participants whose profession requires vigorous physical labor
  • contraindication to magnetic resonance imaging

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750903


Contacts
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Contact: Keith M McGregor, PhD MS BA (404) 321-6111 ext 126792 keith.mcgregor@emory.edu
Contact: Holly Hudson, MPH BS (404) 321-6111 ext 207099 holly.hudson@va.gov

Locations
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United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA Recruiting
Decatur, Georgia, United States, 30033
Contact: Keith M McGregor, PhD MS BA    404-321-6111 ext 126792    keith.mcgregor@emory.edu   
Contact: Holly Hudson, MPH BS    (404) 321-6111 ext 207099    holly.hudson@va.gov   
Principal Investigator: Keith M. McGregor, PhD MS BA         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Keith M. McGregor, PhD MS BA Atlanta VA Medical and Rehab Center, Decatur, GA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03750903     History of Changes
Other Study ID Numbers: E2619-R
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
aging