- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03750903
Aging and Cortical Excitability (ACE)
October 12, 2023 updated by: VA Office of Research and Development
Effects of Aging on Cortical Excitability During Motor Learning
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Medina O Bello
- Phone Number: 206967 (404) 321-6111
- Email: medina.bello@va.gov
Study Contact Backup
- Name: Joe R Nocera, PhD
- Phone Number: 6354 (404) 321-6111
- Email: joe.nocera2@va.gov
Study Locations
-
-
Washington
-
Decatur, Washington, United States, 30033-4004
- Atlanta VA Medical and Rehab Center, Decatur, GA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aerobic Exercise
Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.
|
Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.
Other Names:
|
Active Comparator: Stretching and Balance Training
Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.
|
Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Magnetic Resonance Spectroscopy
Time Frame: Pre/Post 12 week intervention
|
Measuring changes in dynamic magnetic resonance spectroscopy of primary motor cortex during motor learning.
|
Pre/Post 12 week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transcranial Magnetic Stimulation
Time Frame: Pre/Post 12 week intervention
|
Measure changes in TMS measures of cortical excitability pre/post intervention.
|
Pre/Post 12 week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Joe R. Nocera, PhD, Atlanta VA Medical and Rehab Center, Decatur, GA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2019
Primary Completion (Actual)
September 30, 2023
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
November 20, 2018
First Submitted That Met QC Criteria
November 20, 2018
First Posted (Actual)
November 23, 2018
Study Record Updates
Last Update Posted (Actual)
October 16, 2023
Last Update Submitted That Met QC Criteria
October 12, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E2619-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
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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