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/NCT05981989</url>
    </required_header>
    <id_info>
      <org_study_id>IRB112-125-A</org_study_id>
      <nct_id>NCT05981989</nct_id>
    </id_info>
    <brief_title>Epidural Electrical Stimulation for Stroke Patients - Improve Motor and Sensory Function and Alleviate Pain</brief_title>
    <official_title>Epidural Electrical Stimulation for Stroke Patients - Improve Motor and Sensory Function and Alleviate Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Buddhist Tzu Chi General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Buddhist Tzu Chi General Hospital</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>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to verify whether epidural electrical stimulation (EES) of the cervical&#xD;
        spinal cord can activate muscles of the upper limbs in people with hemiplegia following a&#xD;
        stroke.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to verify whether epidural electrical stimulation (EES) of the&#xD;
        cervical spinal cord can activate muscles of the arm and hand in people with hemiplegia&#xD;
        following stroke. Participants will undergo a surgical procedure to implant a system that&#xD;
        provides epidural electrical stimulation (EES) of the cervical spinal cord. After surgery,&#xD;
        Participants will undergo a structured physical rehabilitation program and electrical&#xD;
        stimulation. Researchers will quantify the motor potentials in the arm and hand muscles&#xD;
        generated by EES of the cervical spinal cord, tune optimal stimulation parameters to induced&#xD;
        arm and hand movement, and assess participant motor function of the upper limb with standard&#xD;
        clinical tests and simple motor tasks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</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 motor functioning and sensation as measured by the Fugl-Meyer Assessment (FMA)</measure>
      <time_frame>Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation</time_frame>
      <description>The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is main assesses motor functioning and sensation in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and plan and assess treatment. The upper extremity motor function score ranges from 0 to 66.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change dexterity of the upper limb as measured by the Action Research Arm Test (ARAT)</measure>
      <time_frame>Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation</time_frame>
      <description>Use the Action Research Arm Test (ARAT) assessment to quantify functional hand and arm dexterity. The score ranges from 0 to 57, with a higher value indicating better function.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF)</measure>
      <time_frame>Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation</time_frame>
      <description>The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents &quot;disagree&quot; or &quot;not at all&quot; and 5 represents &quot;completely agree&quot; or &quot;extremely&quot;. , The higher the score, the better the quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in spasticity as measured by the Modified Ashworth Scale (MAS)</measure>
      <time_frame>Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation</time_frame>
      <description>Quantify spasticity scores using the Modified Ashworth Scale (MAS) for the shoulder, elbow, and wrist. The muscle tension is divided into 0-4 grades. The lower the score, the closer to normal. The higher the score, the more severe the spasticity.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Stroke</condition>
    <arm_group>
      <arm_group_label>Epidural electrical stimulation (EES)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will be implanted with 16-electrode epidural array in the C6-T1 area of the spinal cord. After surgery, subjects will undergo a structured program of physical rehabilitation and electrical stimulation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Epidural electrical stimulation (EES)</intervention_name>
      <description>Subjects will undergo a surgical procedure to implant a system that provides epidural electrical stimulation (EES) of the cervical spinal cord. After surgery, subjects will undergo a structured physical rehabilitation program and electrical stimulation.</description>
      <arm_group_label>Epidural electrical stimulation (EES)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Between 20 and 70 years of age&#xD;
  &#xD;
            -  First-ever clinical manifest stroke&#xD;
  &#xD;
            -  Right or left hemiparesis&#xD;
  &#xD;
            -  Scores higher than 7 and lower than 45 on the Fugl-Meyer scale.&#xD;
  &#xD;
            -  Expected will undergo spinal cord stimulation surgery.&#xD;
  &#xD;
            -  Able to comply with procedures and follow up.&#xD;
  &#xD;
            -  Stable medical condition without cardiopulmonary disease or dysautonomia that would&#xD;
               contraindicate participation in upper extremity rehabilitation or testing activities.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy or breast feeding.&#xD;
  &#xD;
            -  Have Major depressive disorder.&#xD;
  &#xD;
            -  Had a mental illness within one year or been treated in the past.&#xD;
  &#xD;
            -  Have significant cognitive impairment (MMSE&lt;24) or serious disease that could affect&#xD;
               the ability to participate in study activities.&#xD;
  &#xD;
            -  Cardiovascular or musculoskeletal disease or injury that would prevent full&#xD;
               participation in physical therapy intervention.&#xD;
  &#xD;
            -  Receiving anticoagulant, anti-spasticity or anti-epileptic medications prior to or&#xD;
               throughout the duration of the study.&#xD;
  &#xD;
            -  Unable to read and/or comprehend the consent form.&#xD;
  &#xD;
            -  Have concerns about this trial and do not sign consent.&#xD;
  &#xD;
            -  Presence of joint contractures deemed by study clinician/investigator to be too severe&#xD;
               to participate in study activities.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sheng-Tzung Tsai, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hualien Tzu Chi General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sheng-Tzung Tsai, M.D., Ph.D.</last_name>
      <phone>+886-3-856-1825</phone>
      <phone_ext>13054</phone_ext>
      <email>flydream.tsai@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yu-Chen Chen, M.D., Ph.D.</last_name>
      <phone>+886-3-856-1825</phone>
      <phone_ext>13054</phone_ext>
      <email>spring810569@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital</name>
        <address>
          <city>Hualien City</city>
          <zip>970</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sheng-Tzung Tsai, M.D., Ph.D.</last_name>
        <phone>+886-3-856-1825</phone>
        <phone_ext>13054</phone_ext>
        <email>flydream.tsai@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Yu-Chen Chen, M.D., Ph.D.</last_name>
        <phone>+886-3-856-1825</phone>
        <phone_ext>13054</phone_ext>
        <email>spring810569@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 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>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/NCT05981989
  org study id: IRB112-125-A
  nct id: NCT05981989
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  This study aims to verify whether epidural electrical stimulation (EES) of the cervical
        spinal cord can activate muscles of the upper limbs in people with hemiplegia following a
        stroke.
  The purpose of this study is to verify whether epidural electrical stimulation (EES) of the
        cervical spinal cord can activate muscles of the arm and hand in people with hemiplegia
        following stroke. Participants will undergo a surgical procedure to implant a system that
        provides epidural electrical stimulation (EES) of the cervical spinal cord. After surgery,
        Participants will undergo a structured physical rehabilitation program and electrical
        stimulation. Researchers will quantify the motor potentials in the arm and hand muscles
        generated by EES of the cervical spinal cord, tune optimal stimulation parameters to induced
        arm and hand movement, and assess participant motor function of the upper limb with standard
        clinical tests and simple motor tasks.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in motor functioning and sensation as measured by the Fugl-Meyer Assessment (FMA)
  time frame: Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
  description: The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is main assesses motor functioning and sensation in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and plan and assess treatment. The upper extremity motor function score ranges from 0 to 66.
  measure: Change dexterity of the upper limb as measured by the Action Research Arm Test (ARAT)
  time frame: Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
  description: Use the Action Research Arm Test (ARAT) assessment to quantify functional hand and arm dexterity. The score ranges from 0 to 57, with a higher value indicating better function.
  measure: Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF)
  time frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation
  description: The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely". , The higher the score, the better the quality of life
  measure: Change in spasticity as measured by the Modified Ashworth Scale (MAS)
  time frame: Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
  description: Quantify spasticity scores using the Modified Ashworth Scale (MAS) for the shoulder, elbow, and wrist. The muscle tension is divided into 0-4 grades. The lower the score, the closer to normal. The higher the score, the more severe the spasticity.
  arm group label: Epidural electrical stimulation (EES)
  arm group type: Experimental
  description: Subjects will be implanted with 16-electrode epidural array in the C6-T1 area of the spinal cord. After surgery, subjects will undergo a structured program of physical rehabilitation and electrical stimulation.
  intervention type: Device
  intervention name: Epidural electrical stimulation (EES)
  description: Subjects will undergo a surgical procedure to implant a system that provides epidural electrical stimulation (EES) of the cervical spinal cord. After surgery, subjects will undergo a structured physical rehabilitation program and electrical stimulation.
  arm group label: Epidural electrical stimulation (EES)
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Sheng-Tzung Tsai, M.D., Ph.D.
  role: Principal Investigator
  affiliation: Hualien Tzu Chi General Hospital
  last name: Sheng-Tzung Tsai, M.D., Ph.D.
  phone: +886-3-856-1825
  phone ext: 13054
  email: flydream.tsai@gmail.com
  last name: Yu-Chen Chen, M.D., Ph.D.
  phone: +886-3-856-1825
  phone ext: 13054
  email: spring810569@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Stroke