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/NCT06019611</url>
    </required_header>
    <id_info>
      <org_study_id>23-003967</org_study_id>
      <nct_id>NCT06019611</nct_id>
    </id_info>
    <brief_title>Epidural Stimulation in Multiple Sclerosis</brief_title>
    <official_title>A Pilot Study to Explore the Use of Percutaneous Spinal Stimulation in Participants With Multiple Sclerosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kristin Zhao, PhD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Mayo Clinic</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A study to quantify changes in motor performance of epidural stimulation in progressive&#xD;
        multiple sclerosis (MS) patients over the course of 12 rehabilitation sessions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this trial is to study spinal motor nerve response to electrical stimulation&#xD;
        delivered directly to the epidural space, and to measure any changes in motor performance&#xD;
        during 12 sessions over the course of one month.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Kinematics</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Change in measurements of joint angles, measured in degrees.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Kinetics</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Change in measurement of movement force and pressure, measured in kilograms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Electromyography (EMG)</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Change in voltage measurements in major muscle groups of the lower extremities.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Spasticity (1)</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Change in measurements of leg muscle tone utilizing Wartenberg's pendulum test, with tone measured via electromyography.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Spasticity (2)</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Change in measurement of leg muscle tone utilizing the Modified Ashworth Scale (MAS). A physical therapist will use a 5-point scale to assess resistance of major muscles during passive range of motion, with a lower score for a muscle indicating less tone.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overground ambulation (1)</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Measurement of changes in overground mobility as measured by the Timed 25-Foot Walk (T25-FW). Trainers will record the time in seconds in which the subject can cover 25 feet, with a lower score characterizing better overground mobility.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overground ambulation (2)</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Measurement of changes in overground mobility as measured by the Timed Up and Go (TUG). Trainers will record the time in seconds in which the subject can stand from a seated position in a chair, traverse 3 meters, turn around, return to the chair, and sit back down. A lower score characterizes better overground mobility.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Balance</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Measurement of changes in ability to perform 14 activities of daily life requiring balance using the Berg Balance Scale. Trainers will assess capabilities in all categories on a 0 to 4 scale, with a higher number indicating greater capability, and total the scores, with a higher total score indicating greater overall balance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disability</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Measurement of changes in patient-reported disability status, utilizing the Short Form (36) Health Survey (SF-36). Questions are numerically ranked, with lower numbers representing more disability. Scores are combined into a composite scale from 0-100, with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fatigue</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Measurement of changes in patient-reported fatigue status, utilizing the Modified Fatigue Impact Scale (MFIS). Items are scaled so that higher scores indicate a greater impact of fatigue on a person's activities. The total MFIS score can range from 0 to 84, with a score of zero equivalent to no fatigue and a score of 84 equivalent to maximum fatigue.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Measurement of changes in patient-reported pain status, utilizing the Pain Effects Scale (PES). Items are scaled so that higher scores indicate a greater impact of pain on a person's activities. The total PES score can range from 5 to 30, with a score of 5 equivalent to no fatigue and a score of 84 equivalent to maximum fatigue.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sexual Satisfaction</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Measurement of changes in patient-reported sexual satisfaction, utilizing the Sexual Satisfaction Scale (SSS). Items are scaled so that lower scores indicate a greater degree of satisfaction with aspects of the person's sex life. The total SSS score can range from 4 to 24, with a score of 4 equivalent to extreme satisfaction and a score of 24 equivalent to extreme dissatisfaction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bladder Control</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Measurement of changes in patient-reported bladder control, utilizing the Bladder Control Scale (BLCS). Items are scaled so that lower scores indicate a greater degree of bladder control. The total BLCS score can range from 0 to 22, with a score of 0 equivalent to complete bladder control and a score of 22 equivalent to very poor bladder control.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bowel Control</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Measurement of changes in patient-reported bladder control, utilizing the Bowel Control Scale (BWCS). Items are scaled so that lower scores indicate a greater degree of bowel control. The total BWCS score can range from 0 to 26, with a score of 0 equivalent to complete bowel control and a score of 26 equivalent to very poor bowel control.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Impact of Visual Impairment</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Measurement of changes in patient-reported visual impairment, utilizing the Impact of Visual Impairment Scale (IVIS). Items are scaled so that lower scores indicate less impairment on simple visual tasks. The total IVIS score can range from 0 to 15, with a score of 0 equivalent to no impairment and a score of 15 equivalent to severe visual impairment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive Dysfunction</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Measurement of changes in patient-reported cognitive dysfunction, utilizing the Perceived Deficits Questionnaire (PDQ). Items are scaled so that lower scores indicate less cognitive dysfunction. The total PDQ score can range from 0 to 80, with a score of 0 equivalent to no cognitive dysfunction and a score of 80 equivalent to extreme cognitive dysfunction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mental Health</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Measurement of changes in patient-reported psychological distress and psychological well-being, utilizing the Mental Health Inventory (MHI). Items are scaled so that higher scores indicate less psychological distress. The raw score range is 38-226, with higher scores equivalent to less psychological distress and greater psychological well-being.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Social Support</measure>
      <time_frame>Through study completion; approximately 4 weeks.</time_frame>
      <description>Measurement of changes in patient-reported availability of social support, utilizing the Modified Social Support Survey (MSSS). Items are scaled so that higher scores indicate more social support. The total MSSS score can range from 18 to 90, with a score of 18 equivalent to no social support and a score of 90 equivalent to strong social support.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Multiple Sclerosis</condition>
    <condition>Demyelinating Disorder</condition>
    <condition>Autoimmune Diseases</condition>
    <arm_group>
      <arm_group_label>Percutaneous Epidural Stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Epidural spinal stimulation will be delivered via percutaneously implanted electrodes during rehabilitation. All implanted electrodes will be removed at the end of trial participation. The effects of epidural stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Percutaneous epidural stimulation</intervention_name>
      <description>Abbott percutaneous trial lead for epidural neurostimulation (Model 3086)&#xD;
  Abbott clinician programmer for epidural and dorsal root ganglion neurostimulation (Model 3874)&#xD;
  Ripple Neuromed Nomad Neurostimulation System</description>
      <arm_group_label>Percutaneous Epidural Stimulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Myelopathy secondary to Progressive MS&#xD;
  &#xD;
            -  No clinical or radiologic MS relapses for &gt; 5 years&#xD;
  &#xD;
            -  EDSS score of 6.5 (constant bilateral assistance required to walk about 20 meters&#xD;
               without resting) as assessed by a Neurologist with a specialty in MS&#xD;
  &#xD;
            -  Able to ambulate 10 feet independently with or without gait aid use&#xD;
  &#xD;
            -  At least 22 years of age&#xD;
  &#xD;
            -  No changes to spasticity medications or dalfampridine over the last 3 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently a prison inmate, or awaiting trial, related to criminal activity&#xD;
  &#xD;
            -  Pregnancy at the time of enrollment&#xD;
  &#xD;
            -  History of chronic and/or treatment resistant urinary tract infection&#xD;
  &#xD;
            -  Spasticity (grade of 4) measured bilaterally in two muscle groups using Modified&#xD;
               Ashworth Scale (MAS). Muscle groups tested will include bilateral knee flexors,&#xD;
               extensors; ankle plantarflexors, dorsiflexors&#xD;
  &#xD;
            -  Unhealed decubitus ulcer&#xD;
  &#xD;
            -  Unhealed skeletal fracture&#xD;
  &#xD;
            -  Receiving diathermy treatment&#xD;
  &#xD;
            -  Active participation in an interventional clinical trial&#xD;
  &#xD;
            -  Any illness or condition which, based on the research team's assessment, will&#xD;
               compromise the patient's ability to comply with the protocol, patient safety, or the&#xD;
               validity of the data collected during this study.&#xD;
  &#xD;
            -  History of coagulopathy or other significant cardiac or medical risk factors for&#xD;
               surgery&#xD;
  &#xD;
            -  Ventilator-dependent respiration&#xD;
  &#xD;
            -  Diagnosed with cardiopulmonary dysfunction (e.g., chronic obstructive pulmonary&#xD;
               disease, cardiac failure, or heart arrhythmia)&#xD;
  &#xD;
            -  Untreated clinical diagnosis of depression&#xD;
  &#xD;
            -  History of frequent hypotension characterized by light headedness, or loss of&#xD;
               consciousness&#xD;
  &#xD;
            -  History of frequent hypertension characterized by headache, or bradycardia&#xD;
  &#xD;
            -  Any active, implanted medical device&#xD;
  &#xD;
            -  Treatment of chemodenervation and/or neurolysis during the trial, or within 6 months&#xD;
               of initiating the trial&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Carol M. Denny</last_name>
      <phone>507-422-9337</phone>
      <email>denny.carol@mayo.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mayo Clinic</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55905</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Carol M. Denny</last_name>
        <phone>507-422-9337</phone>
        <email>denny.carol@mayo.edu</email>
      </contact>
      <investigator>
        <last_name>William O. Tobin, MBBCh, Ph.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Kristin D. Zhao, Ph.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Megan L. Gill, P.T., D.P.T.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Peter J. Grahn, Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Mayo Clinic</investigator_affiliation>
      <investigator_full_name>Kristin Zhao, PhD</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>Multiple Sclerosis</mesh_term>
      <mesh_term>Demyelinating Diseases</mesh_term>
      <mesh_term>Autoimmune Diseases</mesh_term>
      <mesh_term>Sclerosis</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/NCT06019611
  org study id: 23-003967
  nct id: NCT06019611
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  A study to quantify changes in motor performance of epidural stimulation in progressive
        multiple sclerosis (MS) patients over the course of 12 rehabilitation sessions.
  The purpose of this trial is to study spinal motor nerve response to electrical stimulation
        delivered directly to the epidural space, and to measure any changes in motor performance
        during 12 sessions over the course of one month.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Kinematics
  time frame: Through study completion; approximately 4 weeks.
  description: Change in measurements of joint angles, measured in degrees.
  measure: Kinetics
  time frame: Through study completion; approximately 4 weeks.
  description: Change in measurement of movement force and pressure, measured in kilograms
  measure: Electromyography (EMG)
  time frame: Through study completion; approximately 4 weeks.
  description: Change in voltage measurements in major muscle groups of the lower extremities.
  measure: Spasticity (1)
  time frame: Through study completion; approximately 4 weeks.
  description: Change in measurements of leg muscle tone utilizing Wartenberg's pendulum test, with tone measured via electromyography.
  measure: Spasticity (2)
  time frame: Through study completion; approximately 4 weeks.
  description: Change in measurement of leg muscle tone utilizing the Modified Ashworth Scale (MAS). A physical therapist will use a 5-point scale to assess resistance of major muscles during passive range of motion, with a lower score for a muscle indicating less tone.
  measure: Overground ambulation (1)
  time frame: Through study completion; approximately 4 weeks.
  description: Measurement of changes in overground mobility as measured by the Timed 25-Foot Walk (T25-FW). Trainers will record the time in seconds in which the subject can cover 25 feet, with a lower score characterizing better overground mobility.
  measure: Overground ambulation (2)
  time frame: Through study completion; approximately 4 weeks.
  description: Measurement of changes in overground mobility as measured by the Timed Up and Go (TUG). Trainers will record the time in seconds in which the subject can stand from a seated position in a chair, traverse 3 meters, turn around, return to the chair, and sit back down. A lower score characterizes better overground mobility.
  measure: Balance
  time frame: Through study completion; approximately 4 weeks.
  description: Measurement of changes in ability to perform 14 activities of daily life requiring balance using the Berg Balance Scale. Trainers will assess capabilities in all categories on a 0 to 4 scale, with a higher number indicating greater capability, and total the scores, with a higher total score indicating greater overall balance.
  measure: Disability
  time frame: Through study completion; approximately 4 weeks.
  description: Measurement of changes in patient-reported disability status, utilizing the Short Form (36) Health Survey (SF-36). Questions are numerically ranked, with lower numbers representing more disability. Scores are combined into a composite scale from 0-100, with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disability.
  measure: Fatigue
  time frame: Through study completion; approximately 4 weeks.
  description: Measurement of changes in patient-reported fatigue status, utilizing the Modified Fatigue Impact Scale (MFIS). Items are scaled so that higher scores indicate a greater impact of fatigue on a person's activities. The total MFIS score can range from 0 to 84, with a score of zero equivalent to no fatigue and a score of 84 equivalent to maximum fatigue.
  measure: Pain
  time frame: Through study completion; approximately 4 weeks.
  description: Measurement of changes in patient-reported pain status, utilizing the Pain Effects Scale (PES). Items are scaled so that higher scores indicate a greater impact of pain on a person's activities. The total PES score can range from 5 to 30, with a score of 5 equivalent to no fatigue and a score of 84 equivalent to maximum fatigue.
  measure: Sexual Satisfaction
  time frame: Through study completion; approximately 4 weeks.
  description: Measurement of changes in patient-reported sexual satisfaction, utilizing the Sexual Satisfaction Scale (SSS). Items are scaled so that lower scores indicate a greater degree of satisfaction with aspects of the person's sex life. The total SSS score can range from 4 to 24, with a score of 4 equivalent to extreme satisfaction and a score of 24 equivalent to extreme dissatisfaction.
  measure: Bladder Control
  time frame: Through study completion; approximately 4 weeks.
  description: Measurement of changes in patient-reported bladder control, utilizing the Bladder Control Scale (BLCS). Items are scaled so that lower scores indicate a greater degree of bladder control. The total BLCS score can range from 0 to 22, with a score of 0 equivalent to complete bladder control and a score of 22 equivalent to very poor bladder control.
  measure: Bowel Control
  time frame: Through study completion; approximately 4 weeks.
  description: Measurement of changes in patient-reported bladder control, utilizing the Bowel Control Scale (BWCS). Items are scaled so that lower scores indicate a greater degree of bowel control. The total BWCS score can range from 0 to 26, with a score of 0 equivalent to complete bowel control and a score of 26 equivalent to very poor bowel control.
  measure: Impact of Visual Impairment
  time frame: Through study completion; approximately 4 weeks.
  description: Measurement of changes in patient-reported visual impairment, utilizing the Impact of Visual Impairment Scale (IVIS). Items are scaled so that lower scores indicate less impairment on simple visual tasks. The total IVIS score can range from 0 to 15, with a score of 0 equivalent to no impairment and a score of 15 equivalent to severe visual impairment.
  measure: Cognitive Dysfunction
  time frame: Through study completion; approximately 4 weeks.
  description: Measurement of changes in patient-reported cognitive dysfunction, utilizing the Perceived Deficits Questionnaire (PDQ). Items are scaled so that lower scores indicate less cognitive dysfunction. The total PDQ score can range from 0 to 80, with a score of 0 equivalent to no cognitive dysfunction and a score of 80 equivalent to extreme cognitive dysfunction.
  measure: Mental Health
  time frame: Through study completion; approximately 4 weeks.
  description: Measurement of changes in patient-reported psychological distress and psychological well-being, utilizing the Mental Health Inventory (MHI). Items are scaled so that higher scores indicate less psychological distress. The raw score range is 38-226, with higher scores equivalent to less psychological distress and greater psychological well-being.
  measure: Social Support
  time frame: Through study completion; approximately 4 weeks.
  description: Measurement of changes in patient-reported availability of social support, utilizing the Modified Social Support Survey (MSSS). Items are scaled so that higher scores indicate more social support. The total MSSS score can range from 18 to 90, with a score of 18 equivalent to no social support and a score of 90 equivalent to strong social support.
  arm group label: Percutaneous Epidural Stimulation
  arm group type: Experimental
  description: Epidural spinal stimulation will be delivered via percutaneously implanted electrodes during rehabilitation. All implanted electrodes will be removed at the end of trial participation. The effects of epidural stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.
  intervention type: Device
  intervention name: Percutaneous epidural stimulation
  description: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086)
  Abbott clinician programmer for epidural and dorsal root ganglion neurostimulation (Model 3874)
  Ripple Neuromed Nomad Neurostimulation System
  arm group label: Percutaneous Epidural Stimulation
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Carol M. Denny
  phone: 507-422-9337
  email: denny.carol@mayo.edu
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Mayo Clinic
  investigator full name: Kristin Zhao, PhD
  investigator title: Principal Investigator
  mesh term: Multiple Sclerosis
  mesh term: Demyelinating Diseases
  mesh term: Autoimmune Diseases
  mesh term: Sclerosis