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/NCT05966896</url>
    </required_header>
    <id_info>
      <org_study_id>23-0202</org_study_id>
      <secondary_id>1K01HD106928-01A1</secondary_id>
      <nct_id>NCT05966896</nct_id>
    </id_info>
    <brief_title>Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury</brief_title>
    <official_title>Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury: Spared Fibers Proof-of-concept Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Colorado, Denver</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Colorado, Denver</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This proof-of-concept case series will prospectively use magnetic resonance imaging (MRI)&#xD;
        evidence of spared spinal cord neural fibers to guide the selection of 2 research&#xD;
        participants to receive a surgically implanted epidural stimulator with the goal of restoring&#xD;
        voluntary movement after spinal cord injury (SCI).&#xD;
  &#xD;
        Because MRI evidence of spared spinal cord neural fibers demonstrated significant&#xD;
        relationships with responsiveness to epidural stimulation in SCI in retrospective studies,&#xD;
        the proposed study is a traditional feasibility study - a prospective investigation to be&#xD;
        used to capture preliminary safety and effectiveness information to determine if MRI&#xD;
        can/should be used in planning a future pivotal study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an investigator-initiated proof of concept study performed at the University of&#xD;
        Colorado Anschutz Medical Campus (CU Anschutz).&#xD;
  &#xD;
        This 2-case proof-of-concept study will include 2 research participants with motor-complete&#xD;
        SCI to evaluate the performance of the Medtronic epidural stimulator for restoring voluntary&#xD;
        movement below the level of injury.&#xD;
  &#xD;
        Participants will be enrolled at CU Anschutz. Screening data will be reviewed to determine&#xD;
        participant eligibility. Two participants who meet all inclusion criteria and none of the&#xD;
        exclusion criteria will be entered into the study.&#xD;
  &#xD;
        The following treatment regimen will be used: epidural stimulation + 6 months of intensive&#xD;
        outpatient physical therapy.&#xD;
  &#xD;
        Total duration of study participation will be 8 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">May 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>International Standards for Neurological Classification of Spinal Cord Injury lower extremity motor scores (ISNCSCI-LEMS)</measure>
      <time_frame>at day 1, at month 7, and at month 8</time_frame>
      <description>International Standards for Neurological Classification of Spinal Cord Injury lower extremity motor scores (ISNCSCI-LEMS) will be used to measure the degree of voluntary motor change. LEMS is conducted with the participant lying supine and five key muscle groups on each side are tested for their ability to contract against gravity and resistance. A zero to five scale is used with a maximum possible score of 25. ISNCSCI motor testing has been shown to have adequate to excellent interrater reliability in individuals with SCI, and is a valid tool for this population</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The abbreviated World Health Organization Quality of Life (WHOQOL-BREF)</measure>
      <time_frame>at day 1, at month 7, and at month 8</time_frame>
      <description>The abbreviated World Health Organization Quality of Life (WHOQOL-BREF) instrument will be used to measure the degree of participants' perception of change in quality of life after stimulator implantation. The WHOQOL-BREF assesses quality of life within the context of an individual's culture, value systems, personal goals, standards, and concerns. It has been studied and highly recommended for individuals with SCI.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">2</enrollment>
    <condition>Spinal Cord Injuries</condition>
    <arm_group>
      <arm_group_label>Epidural stimulation with PT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Stimulation parameters will be optimized for each lower extremity and joint movement. During physical therapy sessions, electrode configurations may be adjusted as needed to optimize stimulation frequencies, and voltage intensity ranges to best enable voluntary control of lower extremity (ankle, knee, and hip) flexion and extension, as well as standing.&#xD;
  Intensive physical therapy will consist of 3 visits per week over the course of 6 months directed by a licensed physical therapist with over a decade of experience working with individuals with SCI, and the epidural stimulator will be ON continuously during these sessions. Physical therapy will involve neurorehabilitation to facilitate voluntary lower extremity movement in the presence of stimulation, with the research participants in the supine, seated, and standing positions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>implanted epidural stimulator</intervention_name>
      <description>implantable multi-programmable neurostimulation system to deliver electrical stimulation to neural targets in the spinal cord</description>
      <arm_group_label>Epidural stimulation with PT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. AIS B SCI diagnosis&#xD;
  &#xD;
            2. Beyond 6 months of injury date&#xD;
  &#xD;
            3. SCI at a level range of C7-T8 with signs of upper motor neuron injury&#xD;
  &#xD;
            4. 18 years or older&#xD;
  &#xD;
            5. Height 5'1&quot; to 6'3&quot;&#xD;
  &#xD;
            6. Weight 250 lbs or less&#xD;
  &#xD;
            7. Sufficient upper extremity strength to manage a stability aide&#xD;
  &#xD;
            8. MRI evidence of spared spinal cord neural fibers&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Claustrophobia and/or other contraindications to magnetic resonance imaging (MRI)&#xD;
  &#xD;
            2. Unstable or symptomatic cardiorespiratory issues, in the opinion of the investigators&#xD;
  &#xD;
            3. Recent (within 3 months) history of fracture, contractures, pressure sore, DVT,&#xD;
               urinary tract infection, or other infections that might interfere with interventions&#xD;
  &#xD;
            4. Contraindications to epidural stimulator implantation surgery&#xD;
  &#xD;
            5. Received botox injections into the lower extremities within the past 6 months&#xD;
  &#xD;
            6. Pregnancy&#xD;
  &#xD;
            7. Cauda Equina injury&#xD;
  &#xD;
            8. Any other neurological disorder besides SCI&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Andrew C Smith, PT, DPT, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Colorado, Denver</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Andrew C Smith, PT, DPT, PhD</last_name>
      <phone>303-724-0781</phone>
      <email>andrew.c2.smith@cuanschutz.edu</email>
    </overall_contact>
    <reference>
      <citation>Smith AC, Angeli CA, Ugiliweneza B, Weber KA 2nd, Bert RJ, Negahdar M, Mesbah S, Boakye M, Harkema SJ, Rejc E. Spinal cord imaging markers and recovery of standing with epidural stimulation in individuals with clinically motor complete spinal cord injury. Exp Brain Res. 2022 Jan;240(1):279-288. doi: 10.1007/s00221-021-06272-9. Epub 2021 Dec 2.</citation>
      <PMID>34854934</PMID>
    </reference>
    <reference>
      <citation>Rejc E, Smith AC, Weber KA 2nd, Ugiliweneza B, Bert RJ, Negahdar M, Boakye M, Harkema SJ, Angeli CA. Spinal Cord Imaging Markers and Recovery of Volitional Leg Movement With Spinal Cord Epidural Stimulation in Individuals With Clinically Motor Complete Spinal Cord Injury. Front Syst Neurosci. 2020 Oct 21;14:559313. doi: 10.3389/fnsys.2020.559313. eCollection 2020.</citation>
      <PMID>33192348</PMID>
    </reference>
    <reference>
      <citation>Harkema S, Gerasimenko Y, Hodes J, Burdick J, Angeli C, Chen Y, Ferreira C, Willhite A, Rejc E, Grossman RG, Edgerton VR. Effect of epidural stimulation of the lumbosacral spinal cord on voluntary movement, standing, and assisted stepping after motor complete paraplegia: a case study. Lancet. 2011 Jun 4;377(9781):1938-47. doi: 10.1016/S0140-6736(11)60547-3. Epub 2011 May 19.</citation>
      <PMID>21601270</PMID>
    </reference>
    <reference>
      <citation>Angeli CA, Edgerton VR, Gerasimenko YP, Harkema SJ. Altering spinal cord excitability enables voluntary movements after chronic complete paralysis in humans. Brain. 2014 May;137(Pt 5):1394-409. doi: 10.1093/brain/awu038. Epub 2014 Apr 8. Erratum In: Brain. 2015 Feb;138(Pt 2):e330.</citation>
      <PMID>24713270</PMID>
    </reference>
    <reference>
      <citation>Angeli CA, Boakye M, Morton RA, Vogt J, Benton K, Chen Y, Ferreira CK, Harkema SJ. Recovery of Over-Ground Walking after Chronic Motor Complete Spinal Cord Injury. N Engl J Med. 2018 Sep 27;379(13):1244-1250. doi: 10.1056/NEJMoa1803588. Epub 2018 Sep 24.</citation>
      <PMID>30247091</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 17, 2023</last_update_submitted>
    <last_update_submitted_qc>July 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</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>Spinal Cord Injuries</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05966896
  org study id: 23-0202
  secondary id: 1K01HD106928-01A1
  nct id: NCT05966896
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  This proof-of-concept case series will prospectively use magnetic resonance imaging (MRI)
        evidence of spared spinal cord neural fibers to guide the selection of 2 research
        participants to receive a surgically implanted epidural stimulator with the goal of restoring
        voluntary movement after spinal cord injury (SCI).
  
        Because MRI evidence of spared spinal cord neural fibers demonstrated significant
        relationships with responsiveness to epidural stimulation in SCI in retrospective studies,
        the proposed study is a traditional feasibility study - a prospective investigation to be
        used to capture preliminary safety and effectiveness information to determine if MRI
        can/should be used in planning a future pivotal study.
  This is an investigator-initiated proof of concept study performed at the University of
        Colorado Anschutz Medical Campus (CU Anschutz).
  
        This 2-case proof-of-concept study will include 2 research participants with motor-complete
        SCI to evaluate the performance of the Medtronic epidural stimulator for restoring voluntary
        movement below the level of injury.
  
        Participants will be enrolled at CU Anschutz. Screening data will be reviewed to determine
        participant eligibility. Two participants who meet all inclusion criteria and none of the
        exclusion criteria will be entered into the study.
  
        The following treatment regimen will be used: epidural stimulation + 6 months of intensive
        outpatient physical therapy.
  
        Total duration of study participation will be 8 months.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: International Standards for Neurological Classification of Spinal Cord Injury lower extremity motor scores (ISNCSCI-LEMS)
  time frame: at day 1, at month 7, and at month 8
  description: International Standards for Neurological Classification of Spinal Cord Injury lower extremity motor scores (ISNCSCI-LEMS) will be used to measure the degree of voluntary motor change. LEMS is conducted with the participant lying supine and five key muscle groups on each side are tested for their ability to contract against gravity and resistance. A zero to five scale is used with a maximum possible score of 25. ISNCSCI motor testing has been shown to have adequate to excellent interrater reliability in individuals with SCI, and is a valid tool for this population
  measure: The abbreviated World Health Organization Quality of Life (WHOQOL-BREF)
  time frame: at day 1, at month 7, and at month 8
  description: The abbreviated World Health Organization Quality of Life (WHOQOL-BREF) instrument will be used to measure the degree of participants' perception of change in quality of life after stimulator implantation. The WHOQOL-BREF assesses quality of life within the context of an individual's culture, value systems, personal goals, standards, and concerns. It has been studied and highly recommended for individuals with SCI.
  arm group label: Epidural stimulation with PT
  arm group type: Experimental
  description: Stimulation parameters will be optimized for each lower extremity and joint movement. During physical therapy sessions, electrode configurations may be adjusted as needed to optimize stimulation frequencies, and voltage intensity ranges to best enable voluntary control of lower extremity (ankle, knee, and hip) flexion and extension, as well as standing.
  Intensive physical therapy will consist of 3 visits per week over the course of 6 months directed by a licensed physical therapist with over a decade of experience working with individuals with SCI, and the epidural stimulator will be ON continuously during these sessions. Physical therapy will involve neurorehabilitation to facilitate voluntary lower extremity movement in the presence of stimulation, with the research participants in the supine, seated, and standing positions.
  intervention type: Device
  intervention name: implanted epidural stimulator
  description: implantable multi-programmable neurostimulation system to deliver electrical stimulation to neural targets in the spinal cord
  arm group label: Epidural stimulation with PT
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Andrew C Smith, PT, DPT, PhD
  role: Principal Investigator
  affiliation: University of Colorado, Denver
  last name: Andrew C Smith, PT, DPT, PhD
  phone: 303-724-0781
  email: andrew.c2.smith@cuanschutz.edu
  citation: Smith AC, Angeli CA, Ugiliweneza B, Weber KA 2nd, Bert RJ, Negahdar M, Mesbah S, Boakye M, Harkema SJ, Rejc E. Spinal cord imaging markers and recovery of standing with epidural stimulation in individuals with clinically motor complete spinal cord injury. Exp Brain Res. 2022 Jan;240(1):279-288. doi: 10.1007/s00221-021-06272-9. Epub 2021 Dec 2.
  PMID: 34854934
  citation: Rejc E, Smith AC, Weber KA 2nd, Ugiliweneza B, Bert RJ, Negahdar M, Boakye M, Harkema SJ, Angeli CA. Spinal Cord Imaging Markers and Recovery of Volitional Leg Movement With Spinal Cord Epidural Stimulation in Individuals With Clinically Motor Complete Spinal Cord Injury. Front Syst Neurosci. 2020 Oct 21;14:559313. doi: 10.3389/fnsys.2020.559313. eCollection 2020.
  PMID: 33192348
  citation: Harkema S, Gerasimenko Y, Hodes J, Burdick J, Angeli C, Chen Y, Ferreira C, Willhite A, Rejc E, Grossman RG, Edgerton VR. Effect of epidural stimulation of the lumbosacral spinal cord on voluntary movement, standing, and assisted stepping after motor complete paraplegia: a case study. Lancet. 2011 Jun 4;377(9781):1938-47. doi: 10.1016/S0140-6736(11)60547-3. Epub 2011 May 19.
  PMID: 21601270
  citation: Angeli CA, Edgerton VR, Gerasimenko YP, Harkema SJ. Altering spinal cord excitability enables voluntary movements after chronic complete paralysis in humans. Brain. 2014 May;137(Pt 5):1394-409. doi: 10.1093/brain/awu038. Epub 2014 Apr 8. Erratum In: Brain. 2015 Feb;138(Pt 2):e330.
  PMID: 24713270
  citation: Angeli CA, Boakye M, Morton RA, Vogt J, Benton K, Chen Y, Ferreira CK, Harkema SJ. Recovery of Over-Ground Walking after Chronic Motor Complete Spinal Cord Injury. N Engl J Med. 2018 Sep 27;379(13):1244-1250. doi: 10.1056/NEJMoa1803588. Epub 2018 Sep 24.
  PMID: 30247091
  responsible party type: Sponsor
  mesh term: Spinal Cord Injuries
  mesh term: Wounds and Injuries
  sharing ipd: No