<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/NCT04470206</url>
  </required_header>
  <id_info>
    <org_study_id>2020_0080</org_study_id>
    <nct_id>NCT04470206</nct_id>
  </id_info>
  <brief_title>Spinal Cord Stimulation for Neuropathic Pain Relief : Efficacy Study Using the Specific NPSI Questionnaire (NPSI)</brief_title>
  <acronym>NPSI</acronym>
  <official_title>Spinal Cord Stimulation for Neuropathic Pain Relief : Efficacy Study Using the Specific NPSI Questionnaire</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</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>
      Several studies have shown the efficacy of spinal cord stimulation in reducing the intensity&#xD;
      of neuropathic pain. This efficacy is defined as obtaining relief of at least 50% of the&#xD;
      preoperative pain intensity assessed by the visual analog scale or the digital pain scale. No&#xD;
      study has evaluated the efficacy of stimulation specifically on the different components of&#xD;
      neuropathic pain, only an overall improvement in pain has been described.&#xD;
&#xD;
      A specific questionnaire for neuropathic pain has been extensively validated in neuropathic&#xD;
      pain: the Neuropathic Pain Symptom Inventory (NPSI).&#xD;
&#xD;
      Thanks to the multidimensional structure of this questionnaire, investigators propose to&#xD;
      evaluate separately and in a much more specific way the efficacy of spinal cord stimulation&#xD;
      in the short and long term on the different components of neuropathic pain and to define&#xD;
      responders subgroups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 19, 2020</start_date>
  <completion_date type="Anticipated">December 19, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 19, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of spinal cord stimulation on the various symptoms of neuropathic pain using the Neuropathic Pain Symptom Inventory (NPSI), change is being assessed.</measure>
    <time_frame>Day 0; Day 7 after surgery; 3 months, 6 months and 12 months after surgery</time_frame>
    <description>Neuropathic pain score obtained by the NPSI questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of spinal cord stimulation on the psychological level (anxiety and depression)</measure>
    <time_frame>Day 0 and 12 months after surgery</time_frame>
    <description>Anxiety and depression score assessed by Hospital Anxiety and Depression (HAD) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of spinal cord stimulation on quality of life.</measure>
    <time_frame>Day 0 and 12 months after surgery</time_frame>
    <description>Quality of life score assessed by EQ-5D questionnaire</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Neuropathic Pain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with neuropathic pain following surgery or in the context of a complex regional&#xD;
        pain syndrome and requiring spinal cord stimulation in the neurosurgery department of Foch&#xD;
        Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  With neuropathic pain:&#xD;
&#xD;
               -  confirmed (DN4 score&gt; 4/10)&#xD;
&#xD;
               -  going back to one year at least&#xD;
&#xD;
               -  refractory to well-conducted medical treatments&#xD;
&#xD;
          -  Requiring spinal cord stimulation: the indication is validated by the&#xD;
             multidisciplinary meeting (RCP Neuromodulation / Pain at Foch Hospital)&#xD;
&#xD;
          -  Having given his non-opposition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with sepsis&#xD;
&#xD;
          -  Having no well-conducted prior medical treatment&#xD;
&#xD;
          -  With uncontrolled psychiatric disorders (active psychosis, suicidal disorders, severe&#xD;
             depression)&#xD;
&#xD;
          -  with somatoform disorders&#xD;
&#xD;
          -  addicted to alcohol or drugs or withdrawal syndrome&#xD;
&#xD;
          -  Deprived of liberty or under guardianship.&#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>Naoufel Ouerchefani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Foch Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Naoufel Ouerchefani, MD</last_name>
    <phone>01 46 25 35 33</phone>
    <phone_ext>0033</phone_ext>
    <email>n.ouerchefani@hopital-foch.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital Foch</name>
      <address>
        <city>Suresnes</city>
        <state>Ile De France</state>
        <zip>92500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Naoufel Ouerchefani, MD</last_name>
      <phone>0033 1 46 25 35 33</phone>
      <email>n.ouerchefani@hopital-foch.com</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neuropathic pain</keyword>
  <keyword>NPSI</keyword>
  <keyword>Spinal Cord Stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04470206
org study id: 2020_0080
nct id: NCT04470206
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Several studies have shown the efficacy of spinal cord stimulation in reducing the intensity
      of neuropathic pain. This efficacy is defined as obtaining relief of at least 50% of the
      preoperative pain intensity assessed by the visual analog scale or the digital pain scale. No
      study has evaluated the efficacy of stimulation specifically on the different components of
      neuropathic pain, only an overall improvement in pain has been described.

      A specific questionnaire for neuropathic pain has been extensively validated in neuropathic
      pain: the Neuropathic Pain Symptom Inventory (NPSI).

      Thanks to the multidimensional structure of this questionnaire, investigators propose to
      evaluate separately and in a much more specific way the efficacy of spinal cord stimulation
      in the short and long term on the different components of neuropathic pain and to define
      responders subgroups.
observational model: Cohort
time perspective: Prospective
measure: Efficacy of spinal cord stimulation on the various symptoms of neuropathic pain using the Neuropathic Pain Symptom Inventory (NPSI), change is being assessed.
time frame: Day 0; Day 7 after surgery; 3 months, 6 months and 12 months after surgery
description: Neuropathic pain score obtained by the NPSI questionnaire
measure: Efficacy of spinal cord stimulation on the psychological level (anxiety and depression)
time frame: Day 0 and 12 months after surgery
description: Anxiety and depression score assessed by Hospital Anxiety and Depression (HAD) questionnaire
measure: Efficacy of spinal cord stimulation on quality of life.
time frame: Day 0 and 12 months after surgery
description: Quality of life score assessed by EQ-5D questionnaire
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Naoufel Ouerchefani, MD
role: Principal Investigator
affiliation: Foch Hospital
last name: Naoufel Ouerchefani, MD
phone: 01 46 25 35 33
phone ext: 0033
email: n.ouerchefani@hopital-foch.com
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Neuralgia