xml: <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/NCT06001736</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY02000583</org_study_id>
      <nct_id>NCT06001736</nct_id>
    </id_info>
    <brief_title>Utility of CC7 Transfer in Stroke Subtypes</brief_title>
    <official_title>Seventh Cervical Nerve Transfer for Spastic Arm Paresis: A Prospective Analysis of Efficacy in Ischemic vs. Hemorrhagic Stroke</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dartmouth-Hitchcock Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dartmouth-Hitchcock Medical Center</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the limb functional improvement after contralateral&#xD;
        C7 root transfer in stroke patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Spastic limb paresis after stroke is a cause of long-term disability and reduction is quality&#xD;
        of life, with loss of hand dexterity being especially prohibitive. In the recovery phase&#xD;
        after initial injury, neural reorganization occurs and has been observed in both ipsilateral&#xD;
        and contralateral hemispheres. Previous studies have identified contralesional (opposite to&#xD;
        the side of the injury), in other words, ipsilateral, activation in the recovery of paretic&#xD;
        hand function. However, this pathway of recovery is limited due to sparse connections between&#xD;
        the ipsilateral hemisphere and the affected arm/hand. By establishing an anatomic connection&#xD;
        between the ipsilateral hemisphere and the paretic arm with contralateral nerve transfer,&#xD;
        compensatory capacity of the ipsilateral hemisphere is facilitated. This cross neck C7-C7&#xD;
        root transfer is an established procedure for the treatment of brachial plexus injuries and&#xD;
        recently, for the treatment of spastic arm paresis in those with cerebral injury.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 13, 2022</start_date>
    <completion_date type="Anticipated">March 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline in arm function, as measured by the Fugl-Meyer upper-extremity scale.</measure>
      <time_frame>12 months with visits at baseline and months 2, 4, 8, and 12 months after surgery.</time_frame>
      <description>The Fugl-Meyer is a widely used and highly recommended stroke-speciﬁc, performance-based measure of impairment with 5 domains and a possible 226 points.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">95</enrollment>
    <condition>Stroke, Ischemic</condition>
    <condition>Stroke Hemorrhagic</condition>
    <condition>Spastic Hemiparesis</condition>
    <arm_group>
      <arm_group_label>Contralateral C7 root transfer for the treatment of spastic hemiparesis.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The C7 nerve root transfer will occur to the patients on this arm.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Contralateral C7 root transfer for the treatment of spastic hemiparesis.</intervention_name>
      <description>Performing surgery to transfer the C7 nerve to treat stroke patients experiencing spastic hemiparesis.</description>
      <arm_group_label>Contralateral C7 root transfer for the treatment of spastic hemiparesis.</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  History of ischemic or hemorrhagic stroke with resultant arm paresis that has ceased&#xD;
               to improve within 1-5 years of rehabilitation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jennifer Hong, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dartmouth-Hitchcock Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Dartmouth-Health</name>
        <address>
          <city>Lebanon</city>
          <state>New Hampshire</state>
          <zip>03677</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
      <investigator_full_name>Jennifer Hong</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Muscle Spasticity</mesh_term>
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Paresis</mesh_term>
      <mesh_term>Ischemic Stroke</mesh_term>
      <mesh_term>Hemorrhagic Stroke</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06001736
  org study id: STUDY02000583
  nct id: NCT06001736
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the limb functional improvement after contralateral
        C7 root transfer in stroke patients.
  Spastic limb paresis after stroke is a cause of long-term disability and reduction is quality
        of life, with loss of hand dexterity being especially prohibitive. In the recovery phase
        after initial injury, neural reorganization occurs and has been observed in both ipsilateral
        and contralateral hemispheres. Previous studies have identified contralesional (opposite to
        the side of the injury), in other words, ipsilateral, activation in the recovery of paretic
        hand function. However, this pathway of recovery is limited due to sparse connections between
        the ipsilateral hemisphere and the affected arm/hand. By establishing an anatomic connection
        between the ipsilateral hemisphere and the paretic arm with contralateral nerve transfer,
        compensatory capacity of the ipsilateral hemisphere is facilitated. This cross neck C7-C7
        root transfer is an established procedure for the treatment of brachial plexus injuries and
        recently, for the treatment of spastic arm paresis in those with cerebral injury.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change from baseline in arm function, as measured by the Fugl-Meyer upper-extremity scale.
  time frame: 12 months with visits at baseline and months 2, 4, 8, and 12 months after surgery.
  description: The Fugl-Meyer is a widely used and highly recommended stroke-speciﬁc, performance-based measure of impairment with 5 domains and a possible 226 points.
  arm group label: Contralateral C7 root transfer for the treatment of spastic hemiparesis.
  arm group type: Experimental
  description: The C7 nerve root transfer will occur to the patients on this arm.
  intervention type: Procedure
  intervention name: Contralateral C7 root transfer for the treatment of spastic hemiparesis.
  description: Performing surgery to transfer the C7 nerve to treat stroke patients experiencing spastic hemiparesis.
  arm group label: Contralateral C7 root transfer for the treatment of spastic hemiparesis.
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Jennifer Hong, Dr.
  role: Principal Investigator
  affiliation: Dartmouth-Hitchcock Medical Center
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Dartmouth-Hitchcock Medical Center
  investigator full name: Jennifer Hong
  investigator title: Principal Investigator
  mesh term: Muscle Spasticity
  mesh term: Stroke
  mesh term: Paresis
  mesh term: Ischemic Stroke
  mesh term: Hemorrhagic Stroke