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/NCT05991804</url>
    </required_header>
    <id_info>
      <org_study_id>319893</org_study_id>
      <nct_id>NCT05991804</nct_id>
    </id_info>
    <brief_title>Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement</brief_title>
    <acronym>Up-Stim</acronym>
    <official_title>Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University College, London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Royal National Orthopaedic Hospital NHS Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University College, London</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In the United Kingdom, there are more than 1000 new cases of spinal cord injury (SCI) each&#xD;
        year, with around half of these injuries affecting the cervical spine. People who have&#xD;
        reduced function and control affecting their upper limbs may have difficulty carrying out&#xD;
        activities of daily living (ADLs), significantly affecting their independence. Recovering&#xD;
        even partial upper limb function is a top priority among tetraplegics.&#xD;
  &#xD;
        Regaining voluntary function in the upper limb can have a huge impact on quality of life.&#xD;
        Using TSCS in the upper limb for acute SCI can benefit patients early in their&#xD;
        rehabilitation, and may reduce the number of patients with problematic spasticity at&#xD;
        discharge. Transcutaneous spinal cord stimulation (TSCS) may provide a low-cost method of&#xD;
        improving function and spasticity in this cohort.&#xD;
  &#xD;
        We are investigating the effect of adding non-invasive SCS to inpatient rehabilitation on&#xD;
        upper limb function for people with acute SCI. We will test this by randomly assigning&#xD;
        volunteers to either a control group, who will receive their normal inpatient rehabilitation&#xD;
        only, and an intervention group, who will have non-invasive SCS added to their normal&#xD;
        inpatient rehabilitation, targeting their upper limbs.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Recruitment:&#xD;
  &#xD;
        Participants will be recruited from the Royal National Orthopaedic Hospital. A member of our&#xD;
        research team will contact participants after they have received this information sheet to&#xD;
        discuss participation in the study and answer any questions. People who would like to take&#xD;
        part in the study will be asked to attend an initial session to see if they are able to&#xD;
        tolerate non-invasive SCS.&#xD;
  &#xD;
        Intervention:&#xD;
  &#xD;
        Eligible participants will then be randomised into either the control group, where they will&#xD;
        receive their standard inpatient rehabilitation only, or into the intervention group, where&#xD;
        they will have non-invasive SCS added to their inpatient rehabilitation, targeting the arms&#xD;
        and hands.&#xD;
  &#xD;
        For both the control and intervention groups, we will carry out regular assessments. Some of&#xD;
        these assessments will be part of standard care as an inpatient at the RNOH, and others will&#xD;
        be additional. Please see the outcome measures for further information about these&#xD;
        assessments.&#xD;
  &#xD;
        Follow-up:&#xD;
  &#xD;
        When participants have finished their inpatient rehabilitation at the RNOH, we will carry out&#xD;
        a semi-structured interview, where we will ask about participants' experience on this study.&#xD;
        Interviews may take place in person, over the phone, or over video call (e.g. Microsoft Teams&#xD;
        or Zoom).&#xD;
  &#xD;
        After participants have been discharged from the RNOH, we will contact you to do some&#xD;
        follow-up assessments, which can be done at home or over the phone. There will be 2 follow-up&#xD;
        assessments, the first will be done at 6-months post-injury, and the second will be done at&#xD;
        1-year post-injury. If participants are already 6-months post-injury at discharge, then the&#xD;
        first follow-up assessment will be done at 1-month post-discharge, and the second at 1-year&#xD;
        post-injury. The follow-up assessments will be the TUAQ, and the SCI-QoL.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 28, 2023</start_date>
    <completion_date type="Anticipated">April 16, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 16, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Pilot study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in International Standards of Neurological Classification for SCI (ISNC-SCI).</measure>
      <time_frame>30 minutes</time_frame>
      <description>This is a is a clinician-administered scale used to classify the severity (completeness) of injury in individuals with SCI.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Modified Ashworth Scale (MAS)</measure>
      <time_frame>20 minutes</time_frame>
      <description>This is a is a clinician-administered scale used to classify spasticity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Range of Motion (ROM)</measure>
      <time_frame>20 minutes</time_frame>
      <description>This is a is a clinician-administered scale used to classify the angles that can be achieved at each joint of the arm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Electromyography (EMG) assessments</measure>
      <time_frame>90 minutes</time_frame>
      <description>This will be assessed by researchers, and classifies the amount of muscle activity occurring during movements of the arms and hands.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Individual goal planning</measure>
      <time_frame>20 minutes</time_frame>
      <description>This is planned between the participant and their therapist, and defines what is important to the participant to gain from their rehabilitation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Spinal Cord Independence Measure (SCIM)</measure>
      <time_frame>30 minutes</time_frame>
      <description>This is a self-assessed outcome which asks the rater about 3 areas of function: self-care (feeding, grooming, bathing, and dressing), respiration and sphincter management, and mobility</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tetraplegic upper limb activity questionnaire (TUAQ)</measure>
      <time_frame>30 minutes</time_frame>
      <description>This is a self-assessed questionnaire which is a self-assessment of hand and arm function</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>International SCI data sets quality of life basic data set (SCI-QoL)</measure>
      <time_frame>15 minutes</time_frame>
      <description>This is a self-administered short questionnaire which assesses quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Semi-structured interview</measure>
      <time_frame>60 minutes</time_frame>
      <description>Participants will be asked to speak freely about their experience on this project and any recommendations they have for the team for future studies</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">6</enrollment>
    <condition>Spinal Cord Injuries</condition>
    <arm_group>
      <arm_group_label>Inpatient rehabilitation alone</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard inpatient rehabilitation received at the Royal National Orthopaedic Hospital NHS Trust</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Transcutaneous spinal cord stimulation added to inpatient rehabilitation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Transcutaneous spinal cord stimulation added to standard inpatient rehabilitation, targetting the upper limbs, received at the Royal National Orthopaedic Hospital NHS Trust</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Transcutaneous spinal cord stimulation added to inpatient rehabilitation</intervention_name>
      <description>Non-invasive electrical stimulation delivered over the spine, targetting movement of the upper limbs</description>
      <arm_group_label>Transcutaneous spinal cord stimulation added to inpatient rehabilitation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Inpatient rehabilitation alone</intervention_name>
      <description>Standard inpatient rehabilitation given at the Royal National Orthopaedic Hospital NHS Trust</description>
      <arm_group_label>Inpatient rehabilitation alone</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Over the age of 18&#xD;
  &#xD;
            2. Recent spinal cord injury (inpatient at the RNOH)&#xD;
  &#xD;
            3. Spinal cord injury level C1-C8&#xD;
  &#xD;
            4. AIS A-D&#xD;
  &#xD;
            5. Willing and able to provide informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Women who are pregnant, planning pregnancy or breastfeeding&#xD;
  &#xD;
            2. Those who have a cardiac pacemaker&#xD;
  &#xD;
            3. Active device at stimulating electrode site&#xD;
  &#xD;
            4. Any other musculoskeletal diagnosis affecting the upper limbs&#xD;
  &#xD;
            5. Spinal malignancy&#xD;
  &#xD;
            6. Spinal cord injury due to cancerous growth&#xD;
  &#xD;
            7. Auto-immune disorder&#xD;
  &#xD;
            8. Ongoing infection&#xD;
  &#xD;
            9. Uncontrolled autonomic dysreflexia&#xD;
  &#xD;
           10. Complex regional pain syndrome&#xD;
  &#xD;
           11. Neurological degenerative diseases&#xD;
  &#xD;
           12. Peripheral nerve damage affecting the upper limbs&#xD;
  &#xD;
           13. Taking part in a conflicting research study&#xD;
  &#xD;
           14. People who are unable to tolerate TSCS during their first session&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lynsey Duffell, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University College, London</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Joseph Steel, BSc</last_name>
      <phone>02089095500</phone>
      <email>joseph.steel@nhs.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sarah Massey, PhD</last_name>
      <phone>07713582559</phone>
      <email>sarah.massey.13@ucl.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Royal National Orthopaedic Hospital</name>
        <address>
          <city>London</city>
          <zip>HA7 4LP</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ufedo Miachi</last_name>
        <phone>02089093780</phone>
        <email>ufedo.miachi@rnoh.nhs.uk</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Rehabilitation</keyword>
    <keyword>Transcutaneous spinal cord stimulation</keyword>
    <keyword>Upper limb</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Cord Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>As the study is only 6 participants IPD will be provided in study publications.</ipd_description>
    </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/NCT05991804
  org study id: 319893
  nct id: NCT05991804
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In the United Kingdom, there are more than 1000 new cases of spinal cord injury (SCI) each
        year, with around half of these injuries affecting the cervical spine. People who have
        reduced function and control affecting their upper limbs may have difficulty carrying out
        activities of daily living (ADLs), significantly affecting their independence. Recovering
        even partial upper limb function is a top priority among tetraplegics.
  
        Regaining voluntary function in the upper limb can have a huge impact on quality of life.
        Using TSCS in the upper limb for acute SCI can benefit patients early in their
        rehabilitation, and may reduce the number of patients with problematic spasticity at
        discharge. Transcutaneous spinal cord stimulation (TSCS) may provide a low-cost method of
        improving function and spasticity in this cohort.
  
        We are investigating the effect of adding non-invasive SCS to inpatient rehabilitation on
        upper limb function for people with acute SCI. We will test this by randomly assigning
        volunteers to either a control group, who will receive their normal inpatient rehabilitation
        only, and an intervention group, who will have non-invasive SCS added to their normal
        inpatient rehabilitation, targeting their upper limbs.
  Recruitment:
  
        Participants will be recruited from the Royal National Orthopaedic Hospital. A member of our
        research team will contact participants after they have received this information sheet to
        discuss participation in the study and answer any questions. People who would like to take
        part in the study will be asked to attend an initial session to see if they are able to
        tolerate non-invasive SCS.
  
        Intervention:
  
        Eligible participants will then be randomised into either the control group, where they will
        receive their standard inpatient rehabilitation only, or into the intervention group, where
        they will have non-invasive SCS added to their inpatient rehabilitation, targeting the arms
        and hands.
  
        For both the control and intervention groups, we will carry out regular assessments. Some of
        these assessments will be part of standard care as an inpatient at the RNOH, and others will
        be additional. Please see the outcome measures for further information about these
        assessments.
  
        Follow-up:
  
        When participants have finished their inpatient rehabilitation at the RNOH, we will carry out
        a semi-structured interview, where we will ask about participants' experience on this study.
        Interviews may take place in person, over the phone, or over video call (e.g. Microsoft Teams
        or Zoom).
  
        After participants have been discharged from the RNOH, we will contact you to do some
        follow-up assessments, which can be done at home or over the phone. There will be 2 follow-up
        assessments, the first will be done at 6-months post-injury, and the second will be done at
        1-year post-injury. If participants are already 6-months post-injury at discharge, then the
        first follow-up assessment will be done at 1-month post-discharge, and the second at 1-year
        post-injury. The follow-up assessments will be the TUAQ, and the SCI-QoL.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Pilot study
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in International Standards of Neurological Classification for SCI (ISNC-SCI).
  time frame: 30 minutes
  description: This is a is a clinician-administered scale used to classify the severity (completeness) of injury in individuals with SCI.
  measure: Modified Ashworth Scale (MAS)
  time frame: 20 minutes
  description: This is a is a clinician-administered scale used to classify spasticity
  measure: Range of Motion (ROM)
  time frame: 20 minutes
  description: This is a is a clinician-administered scale used to classify the angles that can be achieved at each joint of the arm
  measure: Electromyography (EMG) assessments
  time frame: 90 minutes
  description: This will be assessed by researchers, and classifies the amount of muscle activity occurring during movements of the arms and hands.
  measure: Individual goal planning
  time frame: 20 minutes
  description: This is planned between the participant and their therapist, and defines what is important to the participant to gain from their rehabilitation
  measure: Spinal Cord Independence Measure (SCIM)
  time frame: 30 minutes
  description: This is a self-assessed outcome which asks the rater about 3 areas of function: self-care (feeding, grooming, bathing, and dressing), respiration and sphincter management, and mobility
  measure: Tetraplegic upper limb activity questionnaire (TUAQ)
  time frame: 30 minutes
  description: This is a self-assessed questionnaire which is a self-assessment of hand and arm function
  measure: International SCI data sets quality of life basic data set (SCI-QoL)
  time frame: 15 minutes
  description: This is a self-administered short questionnaire which assesses quality of life
  measure: Semi-structured interview
  time frame: 60 minutes
  description: Participants will be asked to speak freely about their experience on this project and any recommendations they have for the team for future studies
  arm group label: Inpatient rehabilitation alone
  arm group type: Active Comparator
  description: Standard inpatient rehabilitation received at the Royal National Orthopaedic Hospital NHS Trust
  arm group label: Transcutaneous spinal cord stimulation added to inpatient rehabilitation
  arm group type: Experimental
  description: Transcutaneous spinal cord stimulation added to standard inpatient rehabilitation, targetting the upper limbs, received at the Royal National Orthopaedic Hospital NHS Trust
  intervention type: Other
  intervention name: Transcutaneous spinal cord stimulation added to inpatient rehabilitation
  description: Non-invasive electrical stimulation delivered over the spine, targetting movement of the upper limbs
  arm group label: Transcutaneous spinal cord stimulation added to inpatient rehabilitation
  intervention type: Other
  intervention name: Inpatient rehabilitation alone
  description: Standard inpatient rehabilitation given at the Royal National Orthopaedic Hospital NHS Trust
  arm group label: Inpatient rehabilitation alone
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lynsey Duffell, PhD
  role: Principal Investigator
  affiliation: University College, London
  last name: Joseph Steel, BSc
  phone: 02089095500
  email: joseph.steel@nhs.net
  last name: Sarah Massey, PhD
  phone: 07713582559
  email: sarah.massey.13@ucl.ac.uk
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Spinal Cord Injuries
  sharing ipd: No
  ipd description: As the study is only 6 participants IPD will be provided in study publications.