<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/NCT01714349</url>
  </required_header>
  <id_info>
    <org_study_id>NTSCI -201208137</org_study_id>
    <nct_id>NCT01714349</nct_id>
  </id_info>
  <brief_title>Nerve Transfer After Spinal Cord Injuries</brief_title>
  <official_title>Restoring Hand Function Using Nerve Transfers in Persons With Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nerve Transfer surgery can provide improved hand function following cervical spinal cord&#xD;
      injuries&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment&#xD;
      options that provide meaningful improvements in patient quality of life and long-term&#xD;
      functional independence will provide a significant public health impact.&#xD;
&#xD;
      Specific Aim: Measure the efficacy of nerve transfer surgery in the treatment of patients&#xD;
      with complete cervical spinal cord injuries with no hand function. Optimize the efficiency of&#xD;
      nerve transfer surgery by evaluating patient outcomes in relation to patient selection and&#xD;
      optimal timing the the surgery.&#xD;
&#xD;
      Hypothesis: Peripheral nerve transfers in patients with spinal cord injuries will improve&#xD;
      hand function and provide improvement in patient quality of life and functional independence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 20, 2023</completion_date>
  <primary_completion_date type="Actual">March 20, 2023</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 in upper motor strength</measure>
    <time_frame>48 months</time_frame>
    <description>Patients motor strength will be assessed over 48 months of clinical follow-up with conventional manual motor testing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores</measure>
    <time_frame>48 months</time_frame>
    <description>The change in DASH scores will be followed over time and assessed pre-operatively, 6,12, 18, 24, 36 and 48 months post-operatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Short Form 36 (SF-36) scores</measure>
    <time_frame>48 months</time_frame>
    <description>The change in SF-36 scores will be followed over time and assessed pre-operatively, 6, 12, 18, 24. 36 and 48 months post-operatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Michigan Hand Questionnaire (MHQ)</measure>
    <time_frame>48 months</time_frame>
    <description>The change in MHQ will be followed over time and assessed pre-operatively, 6, 12, 18, 24, 36 and 48 months post-operatively.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Rates of Intraoperative and Post-operative complications</measure>
    <time_frame>48 months</time_frame>
    <description>The number of complications within and after the operation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Effect of timing on surgical intervention</measure>
    <time_frame>48 months</time_frame>
    <description>Assess the effect of timing on primary and secondary outcome measures, early (&lt;12 months) vs. (&gt;12 months)</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of reoperation</measure>
    <time_frame>48 months</time_frame>
    <description>The rate at which a patient needs to be operated on again.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hand Function, measured by the Sollerman Hand Function Test</measure>
    <time_frame>48 months</time_frame>
    <description>The Sollerman Hand Function Test is performed as part of an overall evaluation and assessment by study team Occupational Therapist pre-operatively, post-operatively, and at 6 months, 12 months, 18 months, and 24 months. 36 months and 48 months</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>Nerve Transfer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surgical - Nerve transfers for patients with stable cervical spinal cord injuries</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Nerve Transfer</intervention_name>
    <description>A nerve transfer procedure will be individualized to each patient's functional deficit.</description>
    <arm_group_label>Nerve Transfer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18-65 years of age&#xD;
&#xD;
          2. Informed Consent Document (ICD) signed by patient&#xD;
&#xD;
          3. Cervical spinal cord injury resulting in arm &amp; hand functional impairment, with at&#xD;
             least preserved elbow function&#xD;
&#xD;
          4. International Classification of Surgery of the Hand in Tetraplegia (ICSHT) category 0&#xD;
             - 4&#xD;
&#xD;
          5. Patients with a stable American Spinal Injury Association (ASIA) grade of A, B, or C,&#xD;
             or with a diagnosis of central cord syndrome, showing minimal to no evidence of&#xD;
             functional improvement in motor examination after at least 6 months of non-operative&#xD;
             therapy post-injury&#xD;
&#xD;
          6. Appropriate candidate for nerve transfer study&#xD;
&#xD;
          7. Willing and able to comply with the study protocol&#xD;
&#xD;
          8. &lt; 48 months from injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active infection at the operative site or systemic infection&#xD;
&#xD;
          2. Any return or ongoing clinical recovery of distal motor function within 6 months after&#xD;
             injury&#xD;
&#xD;
          3. Physically or mentally compromised&#xD;
&#xD;
          4. Currently undergoing long-term steroid therapy&#xD;
&#xD;
          5. Significant joint contractures and/or limitations in passive range of motion in the&#xD;
             arm or hand&#xD;
&#xD;
          6. Active malignancy&#xD;
&#xD;
          7. Systemic disease that would affect the patient's welfare or the research study&#xD;
&#xD;
          8. Pregnant&#xD;
&#xD;
          9. Immunologically suppressed or immunocompromised&#xD;
&#xD;
         10. Significant pain or hypersensitivity&#xD;
&#xD;
         11. Previous or current injury preventing use of tendon transfers to restore upper&#xD;
             extremity function&#xD;
&#xD;
         12. Affective disorder of a degree that would make outcome assessment and study&#xD;
             participation difficult&#xD;
&#xD;
         13. History of brachial plexus injury or systemic neuropathic process&#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>Wilson Z Ray, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.neurosurgery.wustl.edu</url>
    <description>Washington University Neurosurgery Home Page</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>March 21, 2023</last_update_submitted>
  <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spinal cord injury</keyword>
  <keyword>nerve transfer</keyword>
  <keyword>tetraplegia</keyword>
  <keyword>quadriplegia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT01714349
org study id: NTSCI -201208137
nct id: NCT01714349
lead sponsor: 
collaborator: 
has dmc: No
Nerve Transfer surgery can provide improved hand function following cervical spinal cord
      injuries
Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment
      options that provide meaningful improvements in patient quality of life and long-term
      functional independence will provide a significant public health impact.

      Specific Aim: Measure the efficacy of nerve transfer surgery in the treatment of patients
      with complete cervical spinal cord injuries with no hand function. Optimize the efficiency of
      nerve transfer surgery by evaluating patient outcomes in relation to patient selection and
      optimal timing the the surgery.

      Hypothesis: Peripheral nerve transfers in patients with spinal cord injuries will improve
      hand function and provide improvement in patient quality of life and functional independence.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in upper motor strength
time frame: 48 months
description: Patients motor strength will be assessed over 48 months of clinical follow-up with conventional manual motor testing
measure: Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores
time frame: 48 months
description: The change in DASH scores will be followed over time and assessed pre-operatively, 6,12, 18, 24, 36 and 48 months post-operatively.
measure: Change in Short Form 36 (SF-36) scores
time frame: 48 months
description: The change in SF-36 scores will be followed over time and assessed pre-operatively, 6, 12, 18, 24. 36 and 48 months post-operatively.
measure: Change in Michigan Hand Questionnaire (MHQ)
time frame: 48 months
description: The change in MHQ will be followed over time and assessed pre-operatively, 6, 12, 18, 24, 36 and 48 months post-operatively.
measure: Rates of Intraoperative and Post-operative complications
time frame: 48 months
description: The number of complications within and after the operation.
measure: Effect of timing on surgical intervention
time frame: 48 months
description: Assess the effect of timing on primary and secondary outcome measures, early (<12 months) vs. (>12 months)
measure: Rate of reoperation
time frame: 48 months
description: The rate at which a patient needs to be operated on again.
measure: Hand Function, measured by the Sollerman Hand Function Test
time frame: 48 months
description: The Sollerman Hand Function Test is performed as part of an overall evaluation and assessment by study team Occupational Therapist pre-operatively, post-operatively, and at 6 months, 12 months, 18 months, and 24 months. 36 months and 48 months
arm group label: Nerve Transfer
arm group type: Experimental
description: Surgical - Nerve transfers for patients with stable cervical spinal cord injuries
intervention type: Procedure
intervention name: Nerve Transfer
description: A nerve transfer procedure will be individualized to each patient's functional deficit.
arm group label: Nerve Transfer
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Wilson Z Ray, MD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
url: http://www.neurosurgery.wustl.edu
description: Washington University Neurosurgery Home Page
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries