<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/NCT02987621</url>
  </required_header>
  <id_info>
    <org_study_id>16-6856H</org_study_id>
    <nct_id>NCT02987621</nct_id>
  </id_info>
  <brief_title>Can Transcranial Direct Current Stimulation Improve Ambulation and Fatigue Resistance in People With MS?</brief_title>
  <official_title>Can Transcranial Direct Current Stimulation Improve Ambulation and Fatigue Resistance in People With MS?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Colorado State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Colorado State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this project the investigators will be using non-invasive brain stimulation on people with&#xD;
      multiple sclerosis (PwMS) to improve leg muscle function. Two groups of participants will be&#xD;
      recruited. One group will perform strength testing with and without the brain stimulation.&#xD;
      The second group of participants will perform a fatigue task, pulling against a wire at a low&#xD;
      level of force, with and without the brain stimulation. This type of brain stimulation has&#xD;
      been shown to transiently improve strength and fatigue measures in other populations, e.g.&#xD;
      aged, Parkinson's, and improve cognitive abilities in people with multiple sclerosis. It is&#xD;
      the investigator's hope that the increases in performance seen in other patient groups will&#xD;
      also occur in people with multiple sclerosis. Future investigations will look to apply the&#xD;
      non-invasive brain stimulation technique during physical rehabilitation to improve short and&#xD;
      long term outcomes related to physical function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Leg Muscle Strength With and Without tDCS.</measure>
    <time_frame>At session 1 and minimum of 7 days later</time_frame>
    <description>Knee extensor strength will be tested with tDCS (less than 10V) and sham stimulation (0V). Participants performed maximal voluntary contractions (MVCs) with the knee extensors to objectively determine the weaker leg as more-affected, which was afterwards confirmed by the subject's self-report and used for the subsequent endurance task. This task consisted of a sustained isometric contraction at 15% MVC until volitional task termination and was immediately followed by a post MVC.&#xD;
During tDCS, stimulation intensity was ramped up to 2 mA, started 90 second prior to the task, and extended until task failure or a maximum stimulation length of 20 minutes. For Sham, the current was ramped up to 2 mA, but turned off after 30 seconds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Leg Muscle Endurance With and Without tDCS.</measure>
    <time_frame>At session 1 and minimum of 7 days later.</time_frame>
    <description>Knee extensor endurance (fatigue) will be tested with tDCS (less than 10V) and sham stimulation (0V), as reported as time to failure.&#xD;
During tDCS, stimulation intensity was ramped up to 2 mA, started 90 second prior to the task, and extended until task failure or a maximum stimulation length of 20 minutes. For Sham, the current was ramped up to 2 mA, but turned off after 30 seconds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>6 Minute Walk Test</measure>
    <time_frame>At session 1 and minimum of 7 days later</time_frame>
    <description>After completion of the tDCS/Sham strength assessment participants will perform a 6 minute walk test. The test will be performed in a cordoned off hallway with 2 cones placed 30 meters apart. Once the participants begin walking, a timer will be started and the distance covered every min will be recorded. Participants are allowed to stop and rest during the test if required. Every minute during the walk test participants will be asked their rating of perceived exertion (RPE, 0-10 scale).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Sham first, wash out 7 days, then tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Separated by a minimum of 7 days from the sham treatment in a counterbalance order, all participants will perform leg muscle strength and fatigue testing once with tDCS stimulation.&#xD;
Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials.&#xD;
Sham: Less than 0V of Transcranial Direct Current Stimulation tDCS: Less than 10V of Transcranial Direct Current Stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tDCS first, wash out 7 days, then Sham</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Separated by a minimum of 7 days from the sham treatment in a counterbalance order, all participants will perform leg muscle strength and fatigue testing once with tDCS stimulation.&#xD;
Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials.&#xD;
Sham: Less than 0V of Transcranial Direct Current Stimulation tDCS: Less than 10V of Transcranial Direct Current Stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS</intervention_name>
    <description>Less than 10V of Transcranial Direct Current Stimulation. Sham 0V of Transcranial Direct Current Stimulation.</description>
    <arm_group_label>Sham first, wash out 7 days, then tDCS</arm_group_label>
    <arm_group_label>tDCS first, wash out 7 days, then Sham</arm_group_label>
    <other_name>The Travel Model v2.0 Advanced tDCS Kit</other_name>
    <other_name>The Brian Simulator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medically diagnosed with MS&#xD;
&#xD;
          -  Moderate disability (Patient Determined Disease Steps score 2-6)&#xD;
&#xD;
          -  Self-reported differences in function between the legs (2-5 on a 1-5 scale)&#xD;
&#xD;
          -  People with MS with physician clearance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A relapse of disease symptoms in the last 60 days&#xD;
&#xD;
          -  A condition unrelated to MS that would exacerbate fatigue, such as anemia,&#xD;
             hypothyroidism, shiftwork-related fatigue, B12 deficiency, major sleep disorder, or&#xD;
             major depressive disorder&#xD;
&#xD;
          -  Medical diagnosis or condition that makes participating in exercise training&#xD;
             dangerous, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV,&#xD;
             cancer (other than treated basal cell cancer), other neurological disorders, or&#xD;
             pregnancy&#xD;
&#xD;
          -  History of heart attack or current diagnosis of cardiovascular disease&#xD;
&#xD;
          -  History of seizure disorders (or on medications known to lower seizure threshold),&#xD;
             hydrocephalus (buildup of fluid in the brain), or diabetes&#xD;
&#xD;
          -  Alcohol dependence or abuse (&gt;2 drinks/day), or present history (last six months) of&#xD;
             drug abuse&#xD;
&#xD;
          -  History of significant traumatic brain injury or hydrocephalus&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Recent hospitalization (within the last 3 months) or enforced bed rest/sedentary&#xD;
             state.&#xD;
&#xD;
          -  Presence of metal is present or implanted device or metal object that is not safe for&#xD;
             TMS.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Health and Exercise Science</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80523</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <results_first_submitted>February 11, 2019</results_first_submitted>
  <results_first_submitted_qc>January 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 5, 2020</results_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Colorado State University</investigator_affiliation>
    <investigator_full_name>Thorsten Rudroff</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT02987621/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sham First, Seven Day Wash Out, Then tDCS</title>
          <description>Separated by a minimum of 7 days, participants will perform leg muscle strength and fatigue testing once with tDCS and once with Sham in a counterbalanced order.&#xD;
Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials. Note: the 6 minute walk test was not conducted.&#xD;
The fatigue testing will be measured by time to fatigue with isometric contraction of the knee extensors.&#xD;
tDCS: Less than 10V of Transcranial Direct Current Stimulation&#xD;
Sham tDCS: Sham 0V of Transcranial Direct Current Stimulation</description>
        </group>
        <group group_id="P2">
          <title>tDCS First, 7 Day Wash Out, Then Sham</title>
          <description>Separated by a minimum of 7 days, participants will perform leg muscle strength and fatigue testing once with tDCS and once with Sham in a counterbalanced order.&#xD;
Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials. Note: the 6 minute walk test was not conducted.&#xD;
The fatigue testing will be measured by time to fatigue with isometric contraction of the knee extensors.&#xD;
tDCS: Less than 10V of Transcranial Direct Current Stimulation&#xD;
Sham tDCS: Sham 0V of Transcranial Direct Current Stimulation</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Crossover study</population>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>Separated by a minimum of 7 days, participants will perform leg muscle strength and fatigue testing once with tDCS and once with Sham in a counterbalanced order.&#xD;
Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials. Note: the 6 minute walk test was not conducted.&#xD;
The fatigue testing will be measured by time to fatigue with isometric contraction of the knee extensors.&#xD;
tDCS: Less than 10V of Transcranial Direct Current Stimulation&#xD;
Sham tDCS: Sham 0V of Transcranial Direct Current Stimulation</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Leg Muscle Strength With and Without tDCS.</title>
        <description>Knee extensor strength will be tested with tDCS (less than 10V) and sham stimulation (0V). Participants performed maximal voluntary contractions (MVCs) with the knee extensors to objectively determine the weaker leg as more-affected, which was afterwards confirmed by the subject's self-report and used for the subsequent endurance task. This task consisted of a sustained isometric contraction at 15% MVC until volitional task termination and was immediately followed by a post MVC.&#xD;
During tDCS, stimulation intensity was ramped up to 2 mA, started 90 second prior to the task, and extended until task failure or a maximum stimulation length of 20 minutes. For Sham, the current was ramped up to 2 mA, but turned off after 30 seconds.</description>
        <time_frame>At session 1 and minimum of 7 days later</time_frame>
        <population>Crossover design</population>
        <group_list>
          <group group_id="O1">
            <title>All Study Participants</title>
            <description>Participants will perform leg muscle strength testing with tDCS. On a separate day they will repeat the leg muscle strength testing with Sham stimulation.&#xD;
Leg strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials. Furthermore, participants perform a 6 minute walk.&#xD;
tDCS: Less than 10V of Transcranial Direct Current Stimulation&#xD;
Sham tDCS: Sham 0V of Transcranial Direct Current Stimulation</description>
          </group>
        </group_list>
        <measure>
          <title>Leg Muscle Strength With and Without tDCS.</title>
          <description>Knee extensor strength will be tested with tDCS (less than 10V) and sham stimulation (0V). Participants performed maximal voluntary contractions (MVCs) with the knee extensors to objectively determine the weaker leg as more-affected, which was afterwards confirmed by the subject's self-report and used for the subsequent endurance task. This task consisted of a sustained isometric contraction at 15% MVC until volitional task termination and was immediately followed by a post MVC.&#xD;
During tDCS, stimulation intensity was ramped up to 2 mA, started 90 second prior to the task, and extended until task failure or a maximum stimulation length of 20 minutes. For Sham, the current was ramped up to 2 mA, but turned off after 30 seconds.</description>
          <population>Crossover design</population>
          <units>Newtons</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>tDCS Stimulation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="323" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sham Stimulation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="330" spread="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Leg Muscle Endurance With and Without tDCS.</title>
        <description>Knee extensor endurance (fatigue) will be tested with tDCS (less than 10V) and sham stimulation (0V), as reported as time to failure.&#xD;
During tDCS, stimulation intensity was ramped up to 2 mA, started 90 second prior to the task, and extended until task failure or a maximum stimulation length of 20 minutes. For Sham, the current was ramped up to 2 mA, but turned off after 30 seconds.</description>
        <time_frame>At session 1 and minimum of 7 days later.</time_frame>
        <population>Crossover design</population>
        <group_list>
          <group group_id="O1">
            <title>All Study Participants</title>
            <description>Participants will perform leg muscle strength testing with tDCS. On a separate day they will repeat the leg muscle strength testing with Sham stimulation.&#xD;
Leg strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials. Furthermore, participants perform a 6 minute walk.&#xD;
tDCS: Less than 10V of Transcranial Direct Current Stimulation&#xD;
Sham tDCS: Sham 0V of Transcranial Direct Current Stimulation</description>
          </group>
        </group_list>
        <measure>
          <title>Leg Muscle Endurance With and Without tDCS.</title>
          <description>Knee extensor endurance (fatigue) will be tested with tDCS (less than 10V) and sham stimulation (0V), as reported as time to failure.&#xD;
During tDCS, stimulation intensity was ramped up to 2 mA, started 90 second prior to the task, and extended until task failure or a maximum stimulation length of 20 minutes. For Sham, the current was ramped up to 2 mA, but turned off after 30 seconds.</description>
          <population>Crossover design</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>tDCS Stimulation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1087" spread="938"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sham Stimulation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="872" spread="547"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>6 Minute Walk Test</title>
        <description>After completion of the tDCS/Sham strength assessment participants will perform a 6 minute walk test. The test will be performed in a cordoned off hallway with 2 cones placed 30 meters apart. Once the participants begin walking, a timer will be started and the distance covered every min will be recorded. Participants are allowed to stop and rest during the test if required. Every minute during the walk test participants will be asked their rating of perceived exertion (RPE, 0-10 scale).</description>
        <time_frame>At session 1 and minimum of 7 days later</time_frame>
        <population>No data was collected</population>
        <group_list>
          <group group_id="O1">
            <title>All Study Participants</title>
            <description>Separated by a minimum of 7 days, participants will perform leg muscle strength and fatigue testing once with tDCS and once with Sham in a counterbalanced order.&#xD;
Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials. Note: the 6 minute walk test was not conducted.&#xD;
The fatigue testing will be measured by time to fatigue with isometric contraction of the knee extensors.&#xD;
tDCS: Less than 10V of Transcranial Direct Current Stimulation&#xD;
Sham tDCS: Sham 0V of Transcranial Direct Current Stimulation</description>
          </group>
        </group_list>
        <measure>
          <title>6 Minute Walk Test</title>
          <description>After completion of the tDCS/Sham strength assessment participants will perform a 6 minute walk test. The test will be performed in a cordoned off hallway with 2 cones placed 30 meters apart. Once the participants begin walking, a timer will be started and the distance covered every min will be recorded. Participants are allowed to stop and rest during the test if required. Every minute during the walk test participants will be asked their rating of perceived exertion (RPE, 0-10 scale).</description>
          <population>No data was collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were determined at session 1 and minimum of 7 days later at session 2. No adverse events were reported by participants.</time_frame>
      <desc>The six minute walk test was not performed and therefore no participants were at risk.</desc>
      <group_list>
        <group group_id="E1">
          <title>All Study Participants-Leg Muscle Strength tDCS</title>
          <description>Knee extensor strength was tested for all study participants with tDCS (less than 10V). All study participants performed maximal voluntary contractions (MVCs) with the knee extensors to objectively determine the weaker leg as more-affected, which was afterwards confirmed by the subject's self-report and used for the subsequent endurance task. This task consisted of a sustained isometric contraction at 15% MVC until volitional task termination and was immediately followed by a post MVC.&#xD;
During tDCS, stimulation intensity was ramped up to 2 mA, started 90 second prior to the task, and extended until task failure or a maximum stimulation length of 20 minutes.</description>
        </group>
        <group group_id="E2">
          <title>All Study Participants-Leg Muscle Strength Sham</title>
          <description>Knee extensor strength was tested for all study participants with sham stimulation (0V). All study participants performed maximal voluntary contractions (MVCs) with the knee extensors to objectively determine the weaker leg as more-affected, which was afterwards confirmed by the subject's self-report and used for the subsequent endurance task. This task consisted of a sustained isometric contraction at 15% MVC until volitional task termination and was immediately followed by a post MVC.&#xD;
For Sham, the current was ramped up to 2 mA, but turned off after 30 seconds and extended until task failure or a maximum length of 20 minutes.</description>
        </group>
        <group group_id="E3">
          <title>All Study Participants-Leg Muscle Endurance tDCS</title>
          <description>Knee extensor endurance (fatigue) was tested for all participants with tDCS (less than 10V) as reported as time to failure.&#xD;
During tDCS, stimulation intensity was ramped up to 2 mA, started 90 second prior to the task, and extended until task failure or a maximum stimulation length of 20 minutes.</description>
        </group>
        <group group_id="E4">
          <title>All Study Participants-Leg Muscle Endurance Sham</title>
          <description>Knee extensor endurance (fatigue) was tested for all participants with sham stimulation (0V) as reported as time to failure.&#xD;
The current was ramped up to 2 mA, but turned off after 30 seconds until task failure or a maximum length of 20 minutes.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
              </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="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
              </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>Manager of Research Operations</name_or_title>
      <organization>Colorado State University</organization>
      <phone>9704912242</phone>
      <email>Laurie.Biela@colostate.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/NCT02987621
org study id: 16-6856H
nct id: NCT02987621
lead sponsor: 
has dmc: No
In this project the investigators will be using non-invasive brain stimulation on people with
      multiple sclerosis (PwMS) to improve leg muscle function. Two groups of participants will be
      recruited. One group will perform strength testing with and without the brain stimulation.
      The second group of participants will perform a fatigue task, pulling against a wire at a low
      level of force, with and without the brain stimulation. This type of brain stimulation has
      been shown to transiently improve strength and fatigue measures in other populations, e.g.
      aged, Parkinson's, and improve cognitive abilities in people with multiple sclerosis. It is
      the investigator's hope that the increases in performance seen in other patient groups will
      also occur in people with multiple sclerosis. Future investigations will look to apply the
      non-invasive brain stimulation technique during physical rehabilitation to improve short and
      long term outcomes related to physical function.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Leg Muscle Strength With and Without tDCS.
time frame: At session 1 and minimum of 7 days later
description: Knee extensor strength will be tested with tDCS (less than 10V) and sham stimulation (0V). Participants performed maximal voluntary contractions (MVCs) with the knee extensors to objectively determine the weaker leg as more-affected, which was afterwards confirmed by the subject's self-report and used for the subsequent endurance task. This task consisted of a sustained isometric contraction at 15% MVC until volitional task termination and was immediately followed by a post MVC.
During tDCS, stimulation intensity was ramped up to 2 mA, started 90 second prior to the task, and extended until task failure or a maximum stimulation length of 20 minutes. For Sham, the current was ramped up to 2 mA, but turned off after 30 seconds.
measure: Leg Muscle Endurance With and Without tDCS.
time frame: At session 1 and minimum of 7 days later.
description: Knee extensor endurance (fatigue) will be tested with tDCS (less than 10V) and sham stimulation (0V), as reported as time to failure.
During tDCS, stimulation intensity was ramped up to 2 mA, started 90 second prior to the task, and extended until task failure or a maximum stimulation length of 20 minutes. For Sham, the current was ramped up to 2 mA, but turned off after 30 seconds.
measure: 6 Minute Walk Test
time frame: At session 1 and minimum of 7 days later
description: After completion of the tDCS/Sham strength assessment participants will perform a 6 minute walk test. The test will be performed in a cordoned off hallway with 2 cones placed 30 meters apart. Once the participants begin walking, a timer will be started and the distance covered every min will be recorded. Participants are allowed to stop and rest during the test if required. Every minute during the walk test participants will be asked their rating of perceived exertion (RPE, 0-10 scale).
arm group label: Sham first, wash out 7 days, then tDCS
arm group type: Experimental
description: Separated by a minimum of 7 days from the sham treatment in a counterbalance order, all participants will perform leg muscle strength and fatigue testing once with tDCS stimulation.
Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials.
Sham: Less than 0V of Transcranial Direct Current Stimulation tDCS: Less than 10V of Transcranial Direct Current Stimulation
arm group label: tDCS first, wash out 7 days, then Sham
arm group type: Experimental
description: Separated by a minimum of 7 days from the sham treatment in a counterbalance order, all participants will perform leg muscle strength and fatigue testing once with tDCS stimulation.
Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials.
Sham: Less than 0V of Transcranial Direct Current Stimulation tDCS: Less than 10V of Transcranial Direct Current Stimulation
intervention type: Device
intervention name: tDCS
description: Less than 10V of Transcranial Direct Current Stimulation. Sham 0V of Transcranial Direct Current Stimulation.
arm group label: Sham first, wash out 7 days, then tDCS
arm group label: tDCS first, wash out 7 days, then Sham
other name: The Travel Model v2.0 Advanced tDCS Kit
other name: The Brian Simulator
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Colorado State University
investigator full name: Thorsten Rudroff
investigator title: Assistant Professor
mesh term: Multiple Sclerosis
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 