<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03750903</url>
  </required_header>
  <id_info>
    <org_study_id>E2619-R</org_study_id>
    <nct_id>NCT03750903</nct_id>
  </id_info>
  <brief_title>Aging and Cortical Excitability</brief_title>
  <acronym>ACE</acronym>
  <official_title>Effects of Aging on Cortical Excitability During Motor Learning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the current proposal is to identify 1) how aging-related changes in&#xD;
      GABAergic cortical inhibition affect motor performance, and 2) how aerobic exercise may&#xD;
      improve inhibitory function and facilitate motor learning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current proposal seeks quantify neural inhibition using magnetic resonance spectroscopy&#xD;
      (MRS) and transcranial magnetic stimulation (TMS) in older Veterans to identify how each&#xD;
      measures contributes to aging-related changes in motor performance. Currently, over 56% (11.8&#xD;
      million) of Veterans are over age 60. Recent research has shown that aging is associated with&#xD;
      decreased cortical inhibition and impaired hand motor function. However, this loss of&#xD;
      inhibition is not an inescapable consequence of aging. The investigators' previous work that&#xD;
      healthy older adults who engage in regular physical activity show increased cortical&#xD;
      inhibition and improved dexterity as compared to their sedentary age cohort. This indicates&#xD;
      that aerobic training may reverse aging related changes in cortical inhibition and alteration&#xD;
      of tonic levels of cortical excitability can have a powerful impact on motor performance in&#xD;
      the aging brain. In the current proposal, the investigators will enroll older adults to&#xD;
      assess how different measurements (TMS and MRS) of the dominant inhibitory neurotransmitter&#xD;
      in the brain - GABA differ in relation to motor control. During the MRS scan, participants&#xD;
      will perform a motor learning task to assess change in GABA level throughout the acquisition&#xD;
      session. These data will be compared with measures of cortical inhibition using TMS to&#xD;
      quantify neurotransmitter receptor activity with respect to aging-related changes in motor&#xD;
      performance. The investigators will also be comparing the effects of an aerobic exercise&#xD;
      intervention as compared to a contact matched stretching control. The investigators believe&#xD;
      this project is the first inquiry of its kind and will have an important impact in the&#xD;
      understanding of aging-related neurophysiological changes in the brain and how it can&#xD;
      remediate associated behavioral declines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 4, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Two group parallel design</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Magnetic Resonance Spectroscopy</measure>
    <time_frame>Pre/Post 12 week intervention</time_frame>
    <description>Measuring changes in dynamic magnetic resonance spectroscopy of primary motor cortex during motor learning.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Transcranial Magnetic Stimulation</measure>
    <time_frame>Pre/Post 12 week intervention</time_frame>
    <description>Measure changes in TMS measures of cortical excitability pre/post intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Aerobic Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stretching and Balance Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic Exercise</intervention_name>
    <description>Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.</description>
    <arm_group_label>Aerobic Exercise</arm_group_label>
    <other_name>AE; Exercise</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stretching and Balance Training</intervention_name>
    <description>Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.</description>
    <arm_group_label>Stretching and Balance Training</arm_group_label>
    <other_name>BAL; Balance</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  living persons aged 50-85&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unmanaged diabetes&#xD;
&#xD;
          -  participants completing vigorous exercise per week&#xD;
&#xD;
          -  participants whose profession requires vigorous physical labor&#xD;
&#xD;
          -  contraindication to magnetic resonance imaging&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joe R. Nocera, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Atlanta VA Medical and Rehab Center, Decatur, GA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Medina O Bello</last_name>
    <phone>(404) 321-6111</phone>
    <phone_ext>206967</phone_ext>
    <email>medina.bello@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Joe R Nocera, PhD</last_name>
    <phone>(404) 321-6111</phone>
    <phone_ext>6354</phone_ext>
    <email>joe.nocera2@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Atlanta VA Medical and Rehab Center, Decatur, GA</name>
      <address>
        <city>Decatur</city>
        <state>Washington</state>
        <zip>30033-4004</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Medina O Bello</last_name>
      <phone>404-321-6111</phone>
      <phone_ext>206967</phone_ext>
      <email>medina.bello@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Joe R Nocera, PhD</last_name>
      <phone>(404) 321-6111</phone>
      <phone_ext>6354</phone_ext>
      <email>joe.nocera2@va.gov</email>
    </contact_backup>
    <investigator>
      <last_name>Joe R. Nocera, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>June 14, 2023</last_update_submitted>
  <last_update_submitted_qc>June 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>aging</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03750903
org study id: E2619-R
nct id: NCT03750903
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two group parallel design
primary purpose: Basic Science
masking: None (Open Label)
measure: Magnetic Resonance Spectroscopy
time frame: Pre/Post 12 week intervention
description: Measuring changes in dynamic magnetic resonance spectroscopy of primary motor cortex during motor learning.
measure: Transcranial Magnetic Stimulation
time frame: Pre/Post 12 week intervention
description: Measure changes in TMS measures of cortical excitability pre/post intervention.
arm group label: Aerobic Exercise
arm group type: Experimental
description: Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.
arm group label: Stretching and Balance Training
arm group type: Active Comparator
description: Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.
intervention type: Behavioral
intervention name: Aerobic Exercise
description: Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.
arm group label: Aerobic Exercise
other name: AE; Exercise
intervention type: Behavioral
intervention name: Stretching and Balance Training
description: Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.
arm group label: Stretching and Balance Training
other name: BAL; Balance
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joe R. Nocera, PhD
role: Principal Investigator
affiliation: Atlanta VA Medical and Rehab Center, Decatur, GA
last name: Medina O Bello
phone: (404) 321-6111
phone ext: 206967
email: medina.bello@va.gov
last name: Joe R Nocera, PhD
phone: (404) 321-6111
phone ext: 6354
email: joe.nocera2@va.gov
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
sharing ipd: No