<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/NCT03034629</url>
  </required_header>
  <id_info>
    <org_study_id>20161183</org_study_id>
    <nct_id>NCT03034629</nct_id>
  </id_info>
  <brief_title>Assessing the Stability of Transcranial Magnetic Stimulation Plasticity Responses</brief_title>
  <official_title>Assessing the Reliability and Influence of Timing of Exercise on Transcranial Magnetic Stimulation (TMS) Neuroplasticity Measures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of this proposed study is to assess the reliability of plasticity measured&#xD;
      by transcranial magnetic stimulation (TMS) interleaved with intermittent theta-burst&#xD;
      stimulation plasticity measures and to assess the influence of an acute bout of aerobic&#xD;
      exercise on TMS plasticity measures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 22, 2017</start_date>
  <completion_date type="Actual">September 27, 2021</completion_date>
  <primary_completion_date type="Actual">March 3, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cortical synaptic plasticity</measure>
    <time_frame>Baseline, 1 week</time_frame>
    <description>As measured via Transcranial Magnetic Stimulation (TMS) in mean motor evoked potential (MEP) amplitude</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess TMS plasticity measures on healthy individuals after an acute bout of exercise</measure>
    <time_frame>Baseline, 3 weeks</time_frame>
    <description>As measured via Transcranial Magnetic Stimulation (TMS) in mean motor evoked potential (MEP) amplitude after an acute bout of aerobic exercise</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Short-term aerobic exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One bout of moderate intensity exercise (75% of maximal predicated heart rate).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Short-term aerobic exercise</intervention_name>
    <description>One bout of moderate intensity exercise (75% of maximal predicated heart rate).</description>
    <arm_group_label>Short-term aerobic exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult males and females aged 18-70 years old.&#xD;
&#xD;
          -  Primary language is English&#xD;
&#xD;
          -  Exercise clearance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of cognitive, neurologic or orthopedic conditions that could affect&#xD;
             performance of the testing and training procedures&#xD;
&#xD;
          -  History of migraines&#xD;
&#xD;
          -  History of fainting spells of unknown or undetermined etiology that might constitute&#xD;
             seizures&#xD;
&#xD;
          -  History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or&#xD;
             family history of treatment resistance epilepsy&#xD;
&#xD;
          -  Any current history of psychiatric illness&#xD;
&#xD;
          -  Any unstable medical condition&#xD;
&#xD;
          -  No medication is an absolute exclusion from TMS. Medications will be reviewed by the&#xD;
             Principal Investigator and a decision about inclusion will be made based on the&#xD;
             following:&#xD;
&#xD;
          -  The subject's past medical history, drug does, history of recent medication changes or&#xD;
             duration of treatment, and combination with other central nervous system active drugs.&#xD;
&#xD;
          -  The published TMS guidelines review medications to considered with TMS (Rossi, Hallet,&#xD;
             Rossini, Pascual-Leone, &amp; Safety of TMS Consensus Group, 2009)&#xD;
&#xD;
          -  Any metal in the brain, skull or elsewhere unless approved by the responsible MD&#xD;
&#xD;
          -  Any medical devices (i.e. Cardiac pacemaker, deep brain stimulator, medication&#xD;
             infusion pump, cochlear implant, vagal nerve stimulator)&#xD;
&#xD;
          -  Intracranial lesion&#xD;
&#xD;
          -  Substance abuse or dependence within the past six months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joyce R Gomes-Osman, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>November 24, 2021</last_update_submitted>
  <last_update_submitted_qc>November 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Joyce Rios Gomes Osman</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <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/NCT03034629
org study id: 20161183
nct id: NCT03034629
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall goal of this proposed study is to assess the reliability of plasticity measured
      by transcranial magnetic stimulation (TMS) interleaved with intermittent theta-burst
      stimulation plasticity measures and to assess the influence of an acute bout of aerobic
      exercise on TMS plasticity measures.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in cortical synaptic plasticity
time frame: Baseline, 1 week
description: As measured via Transcranial Magnetic Stimulation (TMS) in mean motor evoked potential (MEP) amplitude
measure: Assess TMS plasticity measures on healthy individuals after an acute bout of exercise
time frame: Baseline, 3 weeks
description: As measured via Transcranial Magnetic Stimulation (TMS) in mean motor evoked potential (MEP) amplitude after an acute bout of aerobic exercise
arm group label: Short-term aerobic exercise
arm group type: Experimental
description: One bout of moderate intensity exercise (75% of maximal predicated heart rate).
intervention type: Behavioral
intervention name: Short-term aerobic exercise
description: One bout of moderate intensity exercise (75% of maximal predicated heart rate).
arm group label: Short-term aerobic exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joyce R Gomes-Osman, PT, PhD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Joyce Rios Gomes Osman
investigator title: Assistant Professor
sharing ipd: No