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/NCT06010251</url>
    </required_header>
    <id_info>
      <org_study_id>20230447</org_study_id>
      <nct_id>NCT06010251</nct_id>
    </id_info>
    <brief_title>Utility of Multisensory Body-Representation in Spinal Cord Injury (SCI) With Pain</brief_title>
    <official_title>Mechanisms and Utility of Multisensory Body- Representation in SCI and SCI-Related Neuropathic Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Miami</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Miami</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>
        The purpose of this study is to investigate the effectiveness of bodily illusions combined&#xD;
        with transcranial direct current stimulation (tDCS) on neuropathic pain symptoms and sensory&#xD;
        functions in participants with spinal cord injury (SCI) and neuropathic pain.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 20, 2023</start_date>
    <completion_date type="Anticipated">October 20, 2026</completion_date>
    <primary_completion_date type="Anticipated">October 20, 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 neuropathic pain severity assessed by Neuropathic Pain Symptom Inventory (NPSI)</measure>
      <time_frame>Baseline, up to 4 weeks</time_frame>
      <description>The NPSI is a self-reported, validated questionnaire that includes 10 items (on different pain sensations, e.g., burning, squeezing, electric-shock, etc.) used to evaluate the properties of neuropathic pain. Each item is scored on an 11-point NRS (0 meaning no symptom and 10 meaning worst symptom), with higher scores indicating more severe neuropathic pain symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in neuropathic pain interference assessed by pain interference questionnaire.</measure>
      <time_frame>Baseline, up to 4 weeks</time_frame>
      <description>The questionnaire consists in a numerical rating of pain interference ranging from 0= No Interference to 10=Extreme interference with activities, mood and sleep</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes associated with sensory function/dysfunction assessed by quantitative sensory testing</measure>
      <time_frame>Baseline, up to 4 weeks</time_frame>
      <description>The sensory test assesses thermal thresholds and includes:&#xD;
  cool detection threshold (CDT), warm detection threshold (WDT), cold pain threshold (CPT), hot pain threshold (HPT), all performed using the method of limits: 0 to 50 Celsius (ºC) all values will be reported in Celsius.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in manageable pain assessed by days of manageable pain questionnaire.</measure>
      <time_frame>Baseline, up to 4 weeks</time_frame>
      <description>This item specifies the total number of days with pain during the last 7 days, including today, and the response categories ranges from 0=none to 7=seven days.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes of psychosocial assessed by Multidimensional Pain Inventory (pain severity subscale)</measure>
      <time_frame>Baseline, up to 4 weeks</time_frame>
      <description>Multidimensional Pain Inventory assesses the psychosocial impact of pain. This scale consists of three questions: 1) pain at the present moment; 2) pain during the past week and 3) suffering because of pain.&#xD;
  The range of the responses are from 0 (no pain or suffering) to 6 (extreme pain or suffering) and the scores of these three questions will be summed to obtain a composite pain severity score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Global impression of changes by PGIC questionnaire</measure>
      <time_frame>Baseline, up to 4 weeks</time_frame>
      <description>Patients' Global Impression of Changes (PGIC) assesses patients' perceptions of changes following treatment. It is a 7-point verbal scale, with the options ranging from &quot;very much improved&quot; (3), &quot;much improved&quot; (2), &quot;minimally improved&quot; (1), &quot;no change&quot; (0), &quot;minimally worsened&quot; (-1) &quot;much worsened&quot; (-2), and &quot;very much worsened&quot; (-3).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Spinal Cord Injuries</condition>
    <condition>Neuropathic Pain</condition>
    <arm_group>
      <arm_group_label>SCI with pain</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will undergo 2-4 weeks of combined intervention including transcranial direct current stimulation (tDCS) and bodily illusions (10 sessions total).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>tDCS and bodily illusions</intervention_name>
      <description>Participants will be required to perform (in person) 10 interventions over a time frame of 2-4 weeks. They can perform this everyday or for a minimum of 2-3 times per week over 4 weeks.&#xD;
  Two types of illusions will be used 15 min each, the rubber hand illusion and the walking illusion to target upper and lower limbs. These procedures will impact the body representation of the participants resulting in bodily illusions.</description>
      <arm_group_label>SCI with pain</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          The study will be open to people of any ethnicity, racial background, and gender.&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
          SCI with Pain:&#xD;
  &#xD;
            1. Men or women&#xD;
  &#xD;
            2. fluent in English&#xD;
  &#xD;
            3. 18-70 years of age who have: (3a) Complete and incomplete SCI, level of injury (above&#xD;
               L1); (3b) Persistent neuropathic pain started after the injury for a minimum of three&#xD;
               months prior to entering the study that is at least moderate in severity, defined as ≥&#xD;
               4 on a Numeric Rating Scale (NRS) ranging 0 to 10.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
          Participants will be excluded if they have:&#xD;
  &#xD;
            1. Major psychiatric disease/disorder (self-reported);&#xD;
  &#xD;
            2. a significant neurological trauma (self-reported) other than SCI;&#xD;
  &#xD;
            3. a recent (one-year) history of alcohol or drug abuse assessed by the Drug Abuse&#xD;
               Screening Test (DAST-10)&#xD;
  &#xD;
            4. history of visual and hearing loss not corrected&#xD;
  &#xD;
            5. history of epilepsy or seizures&#xD;
  &#xD;
            6. any metal implants in the head, or implanted devices such as cochlea implants or&#xD;
               cardiac pacemakers.&#xD;
  &#xD;
          We will not include any special population like:&#xD;
  &#xD;
          Adults unable to consent Individuals who are not yet adults (infants, children, teenagers)&#xD;
          Pregnant women Prisoners&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eva Widerstrom-Noga, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Miami</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Eva Widerstrom-Noga, PhD</last_name>
      <phone>(305)243-7125</phone>
      <email>ewiderstrom-noga@med.miami.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Roberta Vastano, PhD</last_name>
      <phone>754 207 3627</phone>
      <email>rxv331@miami.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Miami</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33136</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Eva Widerstrom-Noga, PhD</last_name>
        <phone>305-243-7125</phone>
        <email>ewiderstrom-noga@med.miami.edu</email>
      </contact>
      <contact_backup>
        <last_name>Roberta Vastano, PhD</last_name>
        <phone>7542073627</phone>
        <email>rxv331@miami.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Eva Widerstrom-Noga, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Roberta Vastano, PhD</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 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Miami</investigator_affiliation>
      <investigator_full_name>Eva Widerstrom-Noga</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Cord Injuries</mesh_term>
      <mesh_term>Neuralgia</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/NCT06010251
  org study id: 20230447
  nct id: NCT06010251
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to investigate the effectiveness of bodily illusions combined
        with transcranial direct current stimulation (tDCS) on neuropathic pain symptoms and sensory
        functions in participants with spinal cord injury (SCI) and neuropathic pain.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in neuropathic pain severity assessed by Neuropathic Pain Symptom Inventory (NPSI)
  time frame: Baseline, up to 4 weeks
  description: The NPSI is a self-reported, validated questionnaire that includes 10 items (on different pain sensations, e.g., burning, squeezing, electric-shock, etc.) used to evaluate the properties of neuropathic pain. Each item is scored on an 11-point NRS (0 meaning no symptom and 10 meaning worst symptom), with higher scores indicating more severe neuropathic pain symptoms.
  measure: Change in neuropathic pain interference assessed by pain interference questionnaire.
  time frame: Baseline, up to 4 weeks
  description: The questionnaire consists in a numerical rating of pain interference ranging from 0= No Interference to 10=Extreme interference with activities, mood and sleep
  measure: Changes associated with sensory function/dysfunction assessed by quantitative sensory testing
  time frame: Baseline, up to 4 weeks
  description: The sensory test assesses thermal thresholds and includes:
  cool detection threshold (CDT), warm detection threshold (WDT), cold pain threshold (CPT), hot pain threshold (HPT), all performed using the method of limits: 0 to 50 Celsius (ºC) all values will be reported in Celsius.
  measure: Change in manageable pain assessed by days of manageable pain questionnaire.
  time frame: Baseline, up to 4 weeks
  description: This item specifies the total number of days with pain during the last 7 days, including today, and the response categories ranges from 0=none to 7=seven days.
  measure: Changes of psychosocial assessed by Multidimensional Pain Inventory (pain severity subscale)
  time frame: Baseline, up to 4 weeks
  description: Multidimensional Pain Inventory assesses the psychosocial impact of pain. This scale consists of three questions: 1) pain at the present moment; 2) pain during the past week and 3) suffering because of pain.
  The range of the responses are from 0 (no pain or suffering) to 6 (extreme pain or suffering) and the scores of these three questions will be summed to obtain a composite pain severity score.
  measure: Change in Global impression of changes by PGIC questionnaire
  time frame: Baseline, up to 4 weeks
  description: Patients' Global Impression of Changes (PGIC) assesses patients' perceptions of changes following treatment. It is a 7-point verbal scale, with the options ranging from "very much improved" (3), "much improved" (2), "minimally improved" (1), "no change" (0), "minimally worsened" (-1) "much worsened" (-2), and "very much worsened" (-3).
  arm group label: SCI with pain
  arm group type: Experimental
  description: Participants will undergo 2-4 weeks of combined intervention including transcranial direct current stimulation (tDCS) and bodily illusions (10 sessions total).
  intervention type: Other
  intervention name: tDCS and bodily illusions
  description: Participants will be required to perform (in person) 10 interventions over a time frame of 2-4 weeks. They can perform this everyday or for a minimum of 2-3 times per week over 4 weeks.
  Two types of illusions will be used 15 min each, the rubber hand illusion and the walking illusion to target upper and lower limbs. These procedures will impact the body representation of the participants resulting in bodily illusions.
  arm group label: SCI with pain
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Eva Widerstrom-Noga, PhD
  role: Principal Investigator
  affiliation: University of Miami
  last name: Eva Widerstrom-Noga, PhD
  phone: (305)243-7125
  email: ewiderstrom-noga@med.miami.edu
  last name: Roberta Vastano, PhD
  phone: 754 207 3627
  email: rxv331@miami.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Miami
  investigator full name: Eva Widerstrom-Noga
  investigator title: Professor
  mesh term: Spinal Cord Injuries
  mesh term: Neuralgia
  sharing ipd: No