<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/NCT01669161</url>
  </required_header>
  <id_info>
    <org_study_id>Mt-St-01</org_study_id>
    <nct_id>NCT01669161</nct_id>
  </id_info>
  <brief_title>Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke</brief_title>
  <official_title>A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Rehabilitation for Improved Upper Limb 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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients (UK only) at least 6 months post stroke, with upper limb deficits, may enroll.&#xD;
      Patients will be randomized to one of two groups - a group implanted with a device that&#xD;
      allows pairing VNS with rehabilitation and a group that only receives rehabilitation (no&#xD;
      implant). Patients have two baseline evaluations, one evaluation after implant but before&#xD;
      initiation of treatment, and then six weeks of rehabilitation or rehabilitation + VNS,&#xD;
      followed by post acute therapy evaluations at 1, 7, and 30 days after the 6-weeks of&#xD;
      treatment. The intent is to assess safety and provide preliminary effectiveness information&#xD;
      for VNS for upper limb functional improvement after stroke. Implanted patients may receive&#xD;
      longer-term treatment and follow-up after the acute study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety</measure>
    <time_frame>6-weeks</time_frame>
    <description>Assessment of adverse events and serious adverse events.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>VNS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VNS (vagus nerve stimulation) paired with rehabilitation as provided by the Vivistim System.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rehab Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rehabilitation only (no implant, no VNS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vivistim System</intervention_name>
    <description>The Vivistim System provides vagus nerve stimulation (VNS) with rehabilitation movements.</description>
    <arm_group_label>VNS</arm_group_label>
    <other_name>VNS, vagus nerve stimulation, paired VNS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rehab Only</intervention_name>
    <description>Rehabilitation without device implant and VNS</description>
    <arm_group_label>Rehab Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Major Inclusion Criteria:&#xD;
&#xD;
          1. History of unilateral supratentorial ischemic stroke that occurred at least 6 months&#xD;
             prior&#xD;
&#xD;
          2. Age &gt; 18 years and &lt; 80 years&#xD;
&#xD;
          3. Right or left sided weakness of upper extremity&#xD;
&#xD;
        Major Exclusion Criteria:&#xD;
&#xD;
          1. Hemorrhagic stroke&#xD;
&#xD;
          2. Any deficits in language or attention that interferes with reasonable study&#xD;
             participation&#xD;
&#xD;
          3. Presence of significant apraxia&#xD;
&#xD;
          4. Profound Sensory loss&#xD;
&#xD;
          5. Active major neurological or psychiatric diagnosis that would likely interfere with&#xD;
             study protocol including alcohol or drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jesse Dawson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>U. Glasgow</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>U. Glasgow / Western Infirmary</name>
      <address>
        <city>Glasgow, Scotland</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://my.americanheart.org/idc/groups/ahamah-public/@wcm/@sop/@scon/documents/downloadable/ucm_471670.pdf</url>
    <description>Abstract presented at the International Stroke Conference (ISC)</description>
  </link>
  <results_reference>
    <citation>Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8.</citation>
    <PMID>26645257</PMID>
  </results_reference>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>October 13, 2016</last_update_submitted>
  <last_update_submitted_qc>October 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Upper</keyword>
  <keyword>Limb</keyword>
  <keyword>Deficits</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>VNS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01669161
org study id: Mt-St-01
nct id: NCT01669161
lead sponsor: 
has dmc: Yes
Patients (UK only) at least 6 months post stroke, with upper limb deficits, may enroll.
      Patients will be randomized to one of two groups - a group implanted with a device that
      allows pairing VNS with rehabilitation and a group that only receives rehabilitation (no
      implant). Patients have two baseline evaluations, one evaluation after implant but before
      initiation of treatment, and then six weeks of rehabilitation or rehabilitation + VNS,
      followed by post acute therapy evaluations at 1, 7, and 30 days after the 6-weeks of
      treatment. The intent is to assess safety and provide preliminary effectiveness information
      for VNS for upper limb functional improvement after stroke. Implanted patients may receive
      longer-term treatment and follow-up after the acute study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety
time frame: 6-weeks
description: Assessment of adverse events and serious adverse events.
arm group label: VNS
arm group type: Experimental
description: VNS (vagus nerve stimulation) paired with rehabilitation as provided by the Vivistim System.
arm group label: Rehab Only
arm group type: Active Comparator
description: Rehabilitation only (no implant, no VNS)
intervention type: Device
intervention name: Vivistim System
description: The Vivistim System provides vagus nerve stimulation (VNS) with rehabilitation movements.
arm group label: VNS
other name: VNS, vagus nerve stimulation, paired VNS
intervention type: Other
intervention name: Rehab Only
description: Rehabilitation without device implant and VNS
arm group label: Rehab Only
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jesse Dawson, MD
role: Principal Investigator
affiliation: U. Glasgow
facility: 
country: United Kingdom
url: http://my.americanheart.org/idc/groups/ahamah-public/@wcm/@sop/@scon/documents/downloadable/ucm_471670.pdf
description: Abstract presented at the International Stroke Conference (ISC)
citation: Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8.
PMID: 26645257
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No