<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/NCT02243020</url>
  </required_header>
  <id_info>
    <org_study_id>MT-St-02</org_study_id>
    <nct_id>NCT02243020</nct_id>
  </id_info>
  <brief_title>VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke</brief_title>
  <official_title>Study MT-St-02 - Stroke - A Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function After Stroke (MicroTransponder's Vivistim System)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MicroTransponder Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MicroTransponder Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary study objectives are to assess the safety and feasibility of the therapy,&#xD;
      including the surgical intervention and stimulation, as well as to provide information on the&#xD;
      appropriateness of the study test measures (assessments) and to provide a basis for sample&#xD;
      size calculations for a larger, pivotal study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Upper Extremity Fugl-Meyer (UEFM)</measure>
    <time_frame>6-weeks</time_frame>
    <description>Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Wolf Motor Function Test Functional Assessment (WMFT)</measure>
    <time_frame>6-weeks</time_frame>
    <description>Measurement of upper limb function/mobility. For Functional Assessment - minimum is 0 and maximum is 3. A higher score means a better outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Stroke</condition>
  <condition>Upper Limb Deficits</condition>
  <arm_group>
    <arm_group_label>Vagus Nerve Stimulation (VNS) + Rehabilitation (1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vagus Nerve Stimulation (VNS)</intervention_name>
    <arm_group_label>Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator</arm_group_label>
    <arm_group_label>Vagus Nerve Stimulation (VNS) + Rehabilitation (1)</arm_group_label>
    <other_name>VNS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. History of ischemic stroke that occurred at least 4 months prior to enrollment, but&#xD;
             not more than 24 months prior&#xD;
&#xD;
          2. Age &gt;30 years and &lt;80 years&#xD;
&#xD;
          3. Right or left sided weakness of upper extremity&#xD;
&#xD;
          4. UEFM score within designated range.&#xD;
&#xD;
          5. At least 10 degrees of wrist extension, 10° of thumb abduction/extension, and at least&#xD;
             10° of extension in at least 2 additional digits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of hemorrhagic stroke&#xD;
&#xD;
          2. Any deficits in language or cognitive functioning that hinders participation, for&#xD;
             example, (aphasia) or unable to follow 2 step commands.&#xD;
&#xD;
          3. Significant sensory loss.&#xD;
&#xD;
          4. Presence of ongoing dysphagia or aspiration difficulties.&#xD;
&#xD;
          5. Active major neurological or psychiatric diagnosis that would likely interfere with&#xD;
             study protocol including prior history of brain lesions (including dementia, etc.),&#xD;
             and current alcohol abuse, drug abuse, or epilepsy.&#xD;
&#xD;
          6. Subject receiving any therapy (medication or otherwise) at study entry that would&#xD;
             interfere with VNS (e.g. drugs that interfere with neurotransmitter mechanisms).&#xD;
             Additionally, no psychoactive medications - including nicotine - may be used during&#xD;
             the acute study.&#xD;
&#xD;
          7. Prior injury to vagus nerve - either bilateral or unilateral (e.g., injury during&#xD;
             carotid endarterectomy)&#xD;
&#xD;
          8. Severe depression&#xD;
&#xD;
          9. Not considered candidate for a device implant surgery (history of adverse reactions to&#xD;
             anesthetics, poor surgical candidate in surgeon's opinion, etc.)&#xD;
&#xD;
         10. Any other implanted device such as a pacemaker or other neurostimulator; any other&#xD;
             investigational device or drug&#xD;
&#xD;
         11. Medical or mental instability (diagnosis of personality disorder, psychosis, or&#xD;
             substance abuse)&#xD;
&#xD;
         12. Pregnant or plan on becoming pregnant or breastfeeding during the study period&#xD;
&#xD;
         13. Currently require, or likely to require, diathermy during the study duration&#xD;
&#xD;
         14. Any health problem requiring surveillance with MRI imaging&#xD;
&#xD;
         15. Active rehabilitation within 4-weeks prior to therapy&#xD;
&#xD;
         16. Botox injections or any other non-study active rehabilitation of the upper extremity&#xD;
             4-weeks prior to and during therapy&#xD;
&#xD;
         17. Severe spasticity of the upper limb&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patty Smith, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Kimberley TJ, Pierce D, Prudente CN, Francisco GE, Yozbatiran N, Smith P, Tarver B, Engineer ND, Alexander Dickie D, Kline DK, Wigginton JG, Cramer SC, Dawson J. Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke. Stroke. 2018 Nov;49(11):2789-2792. doi: 10.1161/STROKEAHA.118.022279.</citation>
    <PMID>30355189</PMID>
  </results_reference>
  <results_reference>
    <citation>Kimberley TJ, Prudente CN, Engineer ND, Pierce D, Tarver B, Cramer SC, Dickie DA, Dawson J. Study protocol for a pivotal randomised study assessing vagus nerve stimulation during rehabilitation for improved upper limb motor function after stroke. Eur Stroke J. 2019 Dec;4(4):363-377. doi: 10.1177/2396987319855306. Epub 2019 Jun 17.</citation>
    <PMID>31903435</PMID>
  </results_reference>
  <results_reference>
    <citation>Dickie DA, Kimberley TJ, Pierce D, Engineer N, Tarver WB, Dawson J. An Exploratory Study of Predictors of Response to Vagus Nerve Stimulation Paired with Upper-Limb Rehabilitation After Ischemic Stroke. Sci Rep. 2019 Nov 4;9(1):15902. doi: 10.1038/s41598-019-52092-x.</citation>
    <PMID>31685853</PMID>
  </results_reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <results_first_submitted>April 24, 2018</results_first_submitted>
  <results_first_submitted_qc>April 24, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 15, 2019</results_first_posted>
  <last_update_submitted>August 22, 2022</last_update_submitted>
  <last_update_submitted_qc>August 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment was from January 2016 through August 2017 at 3 US and 1 UK sites.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Vagus Nerve Stimulation (VNS) + Rehabilitation (1)</title>
          <description>This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.&#xD;
Vagus Nerve Stimulation (VNS)</description>
        </group>
        <group group_id="P2">
          <title>Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator</title>
          <description>This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.&#xD;
Vagus Nerve Stimulation (VNS)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
              </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>NOTE: An additional 5 subjects discontinued prior to group assignment. Three (3) discontinued due to investigator exclusion (poor surgical candidate) and two (2) self excluded (time commitment and surgical concerns). This info is as designated by the protocol and FDA device guidelines (subjects consented but were not implanted with the device).</population>
      <group_list>
        <group group_id="B1">
          <title>Vagus Nerve Stimulation (VNS) + Rehabilitation (1)</title>
          <description>This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.&#xD;
Vagus Nerve Stimulation (VNS)</description>
        </group>
        <group group_id="B2">
          <title>Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator</title>
          <description>This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.&#xD;
Vagus Nerve Stimulation (VNS)</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="8"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="17"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="59.5" spread="7.4"/>
                    <measurement group_id="B2" value="60.0" spread="13.5"/>
                    <measurement group_id="B3" value="59.8" spread="10.5"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time Since Stroke</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.5" spread=".7"/>
                    <measurement group_id="B2" value="1.5" spread=".3"/>
                    <measurement group_id="B3" value="1.5" spread=".5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Upper Extremity Fugl-Meyer (UEFM)</title>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.5" spread="6.4"/>
                    <measurement group_id="B2" value="36.4" spread="9.4"/>
                    <measurement group_id="B3" value="33.2" spread="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Upper Extremity Fugl-Meyer (UEFM)</title>
        <description>Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed.</description>
        <time_frame>6-weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vagus Nerve Stimulation (VNS) + Rehabilitation (1)</title>
            <description>This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.&#xD;
Vagus Nerve Stimulation (VNS)</description>
          </group>
          <group group_id="O2">
            <title>Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator</title>
            <description>This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.&#xD;
Vagus Nerve Stimulation (VNS)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Upper Extremity Fugl-Meyer (UEFM)</title>
          <description>Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="4.8"/>
                    <measurement group_id="O2" value="5.3" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Wolf Motor Function Test Functional Assessment (WMFT)</title>
        <description>Measurement of upper limb function/mobility. For Functional Assessment - minimum is 0 and maximum is 3. A higher score means a better outcome.</description>
        <time_frame>6-weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vagus Nerve Stimulation (VNS) + Rehabilitation (1)</title>
            <description>This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.&#xD;
Vagus Nerve Stimulation (VNS)</description>
          </group>
          <group group_id="O2">
            <title>Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator</title>
            <description>This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.&#xD;
Vagus Nerve Stimulation (VNS)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Wolf Motor Function Test Functional Assessment (WMFT)</title>
          <description>Measurement of upper limb function/mobility. For Functional Assessment - minimum is 0 and maximum is 3. A higher score means a better outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" spread="0.24"/>
                    <measurement group_id="O2" value=".13" spread=".17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Vagus Nerve Stimulation (VNS) + Rehabilitation (1)</title>
          <description>This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.&#xD;
Vagus Nerve Stimulation (VNS)</description>
        </group>
        <group group_id="E2">
          <title>Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator</title>
          <description>This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.&#xD;
Vagus Nerve Stimulation (VNS)</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="8"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Wound Infection</sub_title>
                <description>Infection at surgical site that required intravenous antibiotics. The patient recovered and the system remained implanted</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Shortness of Breath and Dysphagia</sub_title>
                <description>Shortness of breath and dysphagia due to surgical intubation. Subject improved and recovered over several weeks.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Hoarseness</sub_title>
                <description>Hoarseness after surgery due to nerve manipulation. Subject's voice improved over 12 months but did not recover to 100% (significant improvement but not quite to baseline) after injection and voice therapy.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain/Bruising from implant surgery</sub_title>
                <description>Pain or bruising from implant surgery.</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>VP Clinical Affairs</name_or_title>
      <organization>MicroTransponder Inc.</organization>
      <phone>5123714160</phone>
      <email>brent@microtransponder.com</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/NCT02243020
org study id: MT-St-02
nct id: NCT02243020
lead sponsor: 
has dmc: No
The primary study objectives are to assess the safety and feasibility of the therapy,
      including the surgical intervention and stimulation, as well as to provide information on the
      appropriateness of the study test measures (assessments) and to provide a basis for sample
      size calculations for a larger, pivotal study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Upper Extremity Fugl-Meyer (UEFM)
time frame: 6-weeks
description: Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed.
measure: Change in Wolf Motor Function Test Functional Assessment (WMFT)
time frame: 6-weeks
description: Measurement of upper limb function/mobility. For Functional Assessment - minimum is 0 and maximum is 3. A higher score means a better outcome.
arm group label: Vagus Nerve Stimulation (VNS) + Rehabilitation (1)
arm group type: Experimental
description: This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.
arm group label: Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator
arm group type: Active Comparator
description: This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.
intervention type: Device
intervention name: Vagus Nerve Stimulation (VNS)
arm group label: Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator
arm group label: Vagus Nerve Stimulation (VNS) + Rehabilitation (1)
other name: VNS
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Patty Smith, Ph.D.
role: Principal Investigator
affiliation: UT Southwestern
facility: 
facility: 
facility: 
country: United States
citation: Kimberley TJ, Pierce D, Prudente CN, Francisco GE, Yozbatiran N, Smith P, Tarver B, Engineer ND, Alexander Dickie D, Kline DK, Wigginton JG, Cramer SC, Dawson J. Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke. Stroke. 2018 Nov;49(11):2789-2792. doi: 10.1161/STROKEAHA.118.022279.
PMID: 30355189
citation: Kimberley TJ, Prudente CN, Engineer ND, Pierce D, Tarver B, Cramer SC, Dickie DA, Dawson J. Study protocol for a pivotal randomised study assessing vagus nerve stimulation during rehabilitation for improved upper limb motor function after stroke. Eur Stroke J. 2019 Dec;4(4):363-377. doi: 10.1177/2396987319855306. Epub 2019 Jun 17.
PMID: 31903435
citation: Dickie DA, Kimberley TJ, Pierce D, Engineer N, Tarver WB, Dawson J. An Exploratory Study of Predictors of Response to Vagus Nerve Stimulation Paired with Upper-Limb Rehabilitation After Ischemic Stroke. Sci Rep. 2019 Nov 4;9(1):15902. doi: 10.1038/s41598-019-52092-x.
PMID: 31685853
responsible party type: Sponsor
mesh term: Stroke
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 