<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/NCT02239978</url>
  </required_header>
  <id_info>
    <org_study_id>N1480-M</org_study_id>
    <nct_id>NCT02239978</nct_id>
  </id_info>
  <brief_title>Effect of Levodopa on Postural Motor Learning in Parkinson Disease</brief_title>
  <official_title>Effect of Levodopa on Postural Motor Learning in Parkinson Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of this project is to gain a better understanding of whether and how&#xD;
      levodopa (a common anti-Parkinson disease medication) alters postural motor learning in&#xD;
      people with Parkinson disease. A secondary goal is to assess whether motor cortical&#xD;
      excitability, measured via Transcranial magnetic stimulation, is related to postural motor&#xD;
      learning.&#xD;
&#xD;
      Participants with Parkinson disease will complete between 50 and 100 postural perturbations&#xD;
      (via support surface translations), ON and OFF their dopamine replacement therapy (i.e.&#xD;
      levodopa). Adaptation of responses to these perturbations will be tracked. Participants will&#xD;
      also undergo transcranial magnetic stimulation to capture cortical excitability of the brain&#xD;
      (in particular the motor cortex). Cortical excitability will be correlated to adaptation of&#xD;
      stepping (i.e. postural motor learning) ON and OFF levodopa. Investigators will also capture&#xD;
      postural motor learning and cortical excitability in age-matched healthy adults.&#xD;
&#xD;
      Investigators hypothesize that dopamine will have a negative effect on postural motor&#xD;
      learning, and the cortical excitability will be correlated to postural motor learning.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Movement of Center of Mass (COM) After Postural Perturbation</measure>
    <time_frame>Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication</time_frame>
    <description>Investigators will assess (via automated and custom Matlab software) the magnitude of COM movement after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Steps After Postural Perturbation</measure>
    <time_frame>Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication</time_frame>
    <description>Investigators will assess (via automated and custom Matlab software) the number of steps taken after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in First Step Length</measure>
    <time_frame>Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication</time_frame>
    <description>Investigators will assess (via automated and custom Matlab software) the length of the first step after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cortical Excitability</measure>
    <time_frame>TMS data was collected ON and OFF medication during one visit. This visit occurred within 3 weeks of the initial postural control assessments.</time_frame>
    <description>Investigators will assess the cortical excitability of the primary motor cortex in a subset of participants both ON and OFF levodopa. Specifically, we used transcranial magnetic stimulation to stimulate the motor cortex, where we measure muscular activity of the arm (i.e. motor evoked potentials; MEPs). The primary outcome variable noted below is the lowest stimulation setting (measured as a percentage) which results in an MEP in 5 of 10 trials.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">42</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Parkinsons disease</arm_group_label>
    <description>Individuals with Parkinsons disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Age-matched healthy adults</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Postural perturbation</intervention_name>
    <description>Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Parkinsons disease</arm_group_label>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      No Biospecimens will be collected or retained&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals with Parkinson Disease or age-matched healthy adults in the north west United&#xD;
        States (Oregon and Washington state).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 18 and 90 years of age.&#xD;
&#xD;
          -  Individuals with Parkinson Disease&#xD;
&#xD;
          -  Healthy adults age-matched to PD participants&#xD;
&#xD;
          -  Participants with PD will be currently taking dopamine replacement (i.e. Levodopa)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All subjects exclusion criteria:&#xD;
&#xD;
          -  Deep brain stimulation&#xD;
&#xD;
          -  Recent (within 6 months) orthopedic injuries influencing standing or balance&#xD;
&#xD;
          -  Inability to stand independently&#xD;
&#xD;
        Transcranial magnetic stimulation exclusion criteria (for the subset of individuals taking&#xD;
        part in the Transcranial Magnetic Stimulation portion of the study):&#xD;
&#xD;
          -  History of epilepsy or currently taking any epileptic medication,&#xD;
&#xD;
          -  History of seizures&#xD;
&#xD;
          -  Family history of epilepsy or seizures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel S Peterson, PhD MS BS</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Salt Lake City Health Care System, Salt Lake City, UT</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Portland Health Care System, Portland, OR</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Salt Lake City Health Care System, Salt Lake City, UT</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <results_first_submitted>October 5, 2016</results_first_submitted>
  <results_first_submitted_qc>January 4, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">February 23, 2017</results_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson Disease</keyword>
  <keyword>Posture Balance</keyword>
  <keyword>Learning</keyword>
  <keyword>Dopamine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 42 individuals were enrolled in the study (30 people with Parkinson's disease and 12 healthy older adults)</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Parkinsons Disease</title>
          <description>Individuals with Parkinsons disease&#xD;
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Age-matched healthy adults&#xD;
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Parkinsons Disease</title>
          <description>Individuals with Parkinsons disease&#xD;
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Age-matched healthy adults&#xD;
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="42"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.05" spread="9.67"/>
                    <measurement group_id="B2" value="68.04" spread="6.62"/>
                    <measurement group_id="B3" value="67.16" spread="7.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Movement of Center of Mass (COM) After Postural Perturbation</title>
        <description>Investigators will assess (via automated and custom Matlab software) the magnitude of COM movement after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).</description>
        <time_frame>Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication</time_frame>
        <population>We were unable to collect reliable data on some of the people with PD while OFF medication, which is why there is a discrepancy between the &quot;Parkinson's disease&quot; and &quot;Parkinson's disease Off Medication&quot; arms.</population>
        <group_list>
          <group group_id="O1">
            <title>Parkinsons Disease</title>
            <description>Individuals with Parkinsons disease&#xD;
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Age-matched healthy adults&#xD;
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.</description>
          </group>
          <group group_id="O3">
            <title>Parkinson's Disease Off Medication</title>
            <description>These are the same individuals in the &quot;Parkinson's disease&quot; group, but Off their levodopa</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Movement of Center of Mass (COM) After Postural Perturbation</title>
          <description>Investigators will assess (via automated and custom Matlab software) the magnitude of COM movement after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).</description>
          <population>We were unable to collect reliable data on some of the people with PD while OFF medication, which is why there is a discrepancy between the &quot;Parkinson's disease&quot; and &quot;Parkinson's disease Off Medication&quot; arms.</population>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Start Train</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" spread="0.11"/>
                    <measurement group_id="O2" value="0.28" spread="0.05"/>
                    <measurement group_id="O3" value="0.32" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End Train</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" spread="0.10"/>
                    <measurement group_id="O2" value="0.23" spread="0.03"/>
                    <measurement group_id="O3" value="0.31" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Steps After Postural Perturbation</title>
        <description>Investigators will assess (via automated and custom Matlab software) the number of steps taken after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).</description>
        <time_frame>Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication</time_frame>
        <population>We were unable to collect reliable data on some of the people with PD while OFF medication, which is why there is a discrepancy between the &quot;Parkinson's disease&quot; and &quot;Parkinson's disease Off Medication&quot; arms.</population>
        <group_list>
          <group group_id="O1">
            <title>Parkinsons Disease</title>
            <description>Individuals with Parkinsons disease&#xD;
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Age-matched healthy adults&#xD;
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.</description>
          </group>
          <group group_id="O3">
            <title>Parkinson's Disease Off Medication</title>
            <description>These are the same individuals in the &quot;Parkinson's disease&quot; group, but Off their levodopa</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Steps After Postural Perturbation</title>
          <description>Investigators will assess (via automated and custom Matlab software) the number of steps taken after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).</description>
          <population>We were unable to collect reliable data on some of the people with PD while OFF medication, which is why there is a discrepancy between the &quot;Parkinson's disease&quot; and &quot;Parkinson's disease Off Medication&quot; arms.</population>
          <units>Number of steps</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Start Train</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.22" spread="0.9"/>
                    <measurement group_id="O2" value="2.03" spread="0.63"/>
                    <measurement group_id="O3" value="2.09" spread="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End Train</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.92" spread="1.15"/>
                    <measurement group_id="O2" value="1.15" spread="0.28"/>
                    <measurement group_id="O3" value="2.05" spread="1.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in First Step Length</title>
        <description>Investigators will assess (via automated and custom Matlab software) the length of the first step after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).</description>
        <time_frame>Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Parkinsons Disease</title>
            <description>Individuals with Parkinsons disease&#xD;
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Age-matched healthy adults&#xD;
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.</description>
          </group>
          <group group_id="O3">
            <title>Parkinson's Disease Off Medication</title>
            <description>These are the same individuals in the &quot;Parkinson's disease&quot; group, but Off their levodopa</description>
          </group>
        </group_list>
        <measure>
          <title>Change in First Step Length</title>
          <description>Investigators will assess (via automated and custom Matlab software) the length of the first step after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).</description>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Start of Training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.06"/>
                    <measurement group_id="O2" value="0.25" spread="0.11"/>
                    <measurement group_id="O3" value="0.21" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="0.08"/>
                    <measurement group_id="O2" value="0.27" spread="0.08"/>
                    <measurement group_id="O3" value="0.21" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cortical Excitability</title>
        <description>Investigators will assess the cortical excitability of the primary motor cortex in a subset of participants both ON and OFF levodopa. Specifically, we used transcranial magnetic stimulation to stimulate the motor cortex, where we measure muscular activity of the arm (i.e. motor evoked potentials; MEPs). The primary outcome variable noted below is the lowest stimulation setting (measured as a percentage) which results in an MEP in 5 of 10 trials.</description>
        <time_frame>TMS data was collected ON and OFF medication during one visit. This visit occurred within 3 weeks of the initial postural control assessments.</time_frame>
        <population>As noted in our protocol, TMS was assessed in a subgroup of participants with PD. Seven of the 28 PD participants and 0 of the &quot;control&quot; group (healthy adults) were assessed. PD participants were assessed ON and OFF levodopa. We chose this approach because 1) this aim was exploratory in nature, and 2) MEPs of healthy adults are well characterized.</population>
        <group_list>
          <group group_id="O1">
            <title>Parkinsons Disease</title>
            <description>Individuals with Parkinsons disease&#xD;
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.</description>
          </group>
          <group group_id="O2">
            <title>Parkinson's Disease Off Medication</title>
            <description>These are the same participants as in the Parkinson's disease group, assessed &quot;Off&quot; their levodopa medication</description>
          </group>
        </group_list>
        <measure>
          <title>Cortical Excitability</title>
          <description>Investigators will assess the cortical excitability of the primary motor cortex in a subset of participants both ON and OFF levodopa. Specifically, we used transcranial magnetic stimulation to stimulate the motor cortex, where we measure muscular activity of the arm (i.e. motor evoked potentials; MEPs). The primary outcome variable noted below is the lowest stimulation setting (measured as a percentage) which results in an MEP in 5 of 10 trials.</description>
          <population>As noted in our protocol, TMS was assessed in a subgroup of participants with PD. Seven of the 28 PD participants and 0 of the &quot;control&quot; group (healthy adults) were assessed. PD participants were assessed ON and OFF levodopa. We chose this approach because 1) this aim was exploratory in nature, and 2) MEPs of healthy adults are well characterized.</population>
          <units>% max stim output</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.57" spread="8.73"/>
                    <measurement group_id="O2" value="40.71" spread="9.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Parkinsons Disease</title>
          <description>Individuals with Parkinsons disease&#xD;
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Age-matched healthy adults&#xD;
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Daniel Peterson</name_or_title>
      <organization>Salt Lake City VA</organization>
      <phone>6028242279</phone>
      <email>daniel.peterson1@asu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02239978
org study id: N1480-M
nct id: NCT02239978
lead sponsor: 
collaborator: 
has dmc: No
The primary goal of this project is to gain a better understanding of whether and how
      levodopa (a common anti-Parkinson disease medication) alters postural motor learning in
      people with Parkinson disease. A secondary goal is to assess whether motor cortical
      excitability, measured via Transcranial magnetic stimulation, is related to postural motor
      learning.

      Participants with Parkinson disease will complete between 50 and 100 postural perturbations
      (via support surface translations), ON and OFF their dopamine replacement therapy (i.e.
      levodopa). Adaptation of responses to these perturbations will be tracked. Participants will
      also undergo transcranial magnetic stimulation to capture cortical excitability of the brain
      (in particular the motor cortex). Cortical excitability will be correlated to adaptation of
      stepping (i.e. postural motor learning) ON and OFF levodopa. Investigators will also capture
      postural motor learning and cortical excitability in age-matched healthy adults.

      Investigators hypothesize that dopamine will have a negative effect on postural motor
      learning, and the cortical excitability will be correlated to postural motor learning.
observational model: Cohort
time perspective: Cross-Sectional
measure: Change in Movement of Center of Mass (COM) After Postural Perturbation
time frame: Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication
description: Investigators will assess (via automated and custom Matlab software) the magnitude of COM movement after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).
measure: Change in Steps After Postural Perturbation
time frame: Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication
description: Investigators will assess (via automated and custom Matlab software) the number of steps taken after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).
measure: Change in First Step Length
time frame: Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication
description: Investigators will assess (via automated and custom Matlab software) the length of the first step after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).
measure: Cortical Excitability
time frame: TMS data was collected ON and OFF medication during one visit. This visit occurred within 3 weeks of the initial postural control assessments.
description: Investigators will assess the cortical excitability of the primary motor cortex in a subset of participants both ON and OFF levodopa. Specifically, we used transcranial magnetic stimulation to stimulate the motor cortex, where we measure muscular activity of the arm (i.e. motor evoked potentials; MEPs). The primary outcome variable noted below is the lowest stimulation setting (measured as a percentage) which results in an MEP in 5 of 10 trials.
arm group label: Parkinsons disease
description: Individuals with Parkinsons disease
arm group label: Control
description: Age-matched healthy adults
intervention type: Behavioral
intervention name: Postural perturbation
description: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.
arm group label: Control
arm group label: Parkinsons disease
No Biospecimens will be collected or retained
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel S Peterson, PhD MS BS
role: Principal Investigator
affiliation: VA Salt Lake City Health Care System, Salt Lake City, UT
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 