<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/NCT03259451</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_3045_rTMS-CIC</org_study_id>
    <nct_id>NCT03259451</nct_id>
  </id_info>
  <brief_title>Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Neuropathic Pain</brief_title>
  <acronym>rTMS-CIC</acronym>
  <official_title>Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Neuropathic Pain: Retrospective Study on a Cohort of 149 Patients at Rennes University Hospital, From January 2014 to December 2015</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      A retrospective, monocentric, observational, descriptive, open study of a cohort of 149&#xD;
      patients from January 2014 to December 2015&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neuropathic pain is a public health problem because of its prevalence reaching nearly 7% of&#xD;
      the general population and the effectiveness of current treatments often remains incomplete:&#xD;
      only 30-40% of patients are relieved of 50% of their pain by a pharmacological approach.&#xD;
&#xD;
      As early as the 1990s, stimulation of the motor cortex by implanted electrodes made it&#xD;
      possible to successfully treat certain chronic refractory neuropathic pain. In 1995 it was&#xD;
      reported that the application of repeated shocks by transcranial magnetic stimulation of the&#xD;
      motor cortex could induce an analgesic effect in a patient suffering from neuropathic pain.&#xD;
&#xD;
      This technique has proved its analgesic efficacy after an induction treatment over 5 days, in&#xD;
      the context of chronic pain (neuropathic or fibromyalgia), but all the patients are not&#xD;
      responders and there is currently, Of predictive criteria for response. It seems important to&#xD;
      continue studies on this non-medicinal, non-invasive therapy with no significant adverse&#xD;
      effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">September 26, 2016</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the efficacy of rTMS in the treatment of chronic neuropathic pain in a short term</measure>
    <time_frame>Day 7</time_frame>
    <description>Improvement of pain symptoms by at least 30% on the numerical scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the efficacy of rTMS in the treatment of chronic neuropathic pain in a short term (≤ 1 month)</measure>
    <time_frame>Month 1</time_frame>
    <description>Improvement of pain symptoms by at least 30% on the numerical scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effectiveness of rTMS in the treatment of long-term chronic neuropathic pain (&gt; 6 months)</measure>
    <time_frame>Month 6</time_frame>
    <description>Persistence of at least 30% improvement in pain symptoms on a numerical scale at the end of the sixth month (M6)</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Neuropathic Pain</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Repetitive Transcranial Magnetic Stimulation (rTMS)</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with chronic neuropathic pain&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - patient older than 18 years old with chronic neuropathic pain who are resistant to drug&#xD;
        therapy for which treatment with rTMS is indicated between January 2014 and December 2015&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient less than 18 years old&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Non-neuropathic pain&#xD;
&#xD;
          -  Pain &lt;6 months&#xD;
&#xD;
          -  Unbalanced epilepsy&#xD;
&#xD;
          -  Patient with a contraindication for cerebral MRI (cochlear implant, ocular metallic&#xD;
             foreign bodies, patient with a pacemaker, mechanical valve)&#xD;
&#xD;
          -  Psychiatric pathology&#xD;
&#xD;
          -  Person subject to major legal protection (safeguarding justice, guardianship,&#xD;
             trusteeship), persons deprived of liberty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>April 11, 2018</last_update_submitted>
  <last_update_submitted_qc>April 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2018</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>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>


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/NCT03259451
org study id: 35RC16_3045_rTMS-CIC
nct id: NCT03259451
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A retrospective, monocentric, observational, descriptive, open study of a cohort of 149
      patients from January 2014 to December 2015
Neuropathic pain is a public health problem because of its prevalence reaching nearly 7% of
      the general population and the effectiveness of current treatments often remains incomplete:
      only 30-40% of patients are relieved of 50% of their pain by a pharmacological approach.

      As early as the 1990s, stimulation of the motor cortex by implanted electrodes made it
      possible to successfully treat certain chronic refractory neuropathic pain. In 1995 it was
      reported that the application of repeated shocks by transcranial magnetic stimulation of the
      motor cortex could induce an analgesic effect in a patient suffering from neuropathic pain.

      This technique has proved its analgesic efficacy after an induction treatment over 5 days, in
      the context of chronic pain (neuropathic or fibromyalgia), but all the patients are not
      responders and there is currently, Of predictive criteria for response. It seems important to
      continue studies on this non-medicinal, non-invasive therapy with no significant adverse
      effects.
observational model: Cohort
time perspective: Retrospective
measure: Evaluation of the efficacy of rTMS in the treatment of chronic neuropathic pain in a short term
time frame: Day 7
description: Improvement of pain symptoms by at least 30% on the numerical scale
measure: Evaluation of the efficacy of rTMS in the treatment of chronic neuropathic pain in a short term (≤ 1 month)
time frame: Month 1
description: Improvement of pain symptoms by at least 30% on the numerical scale
measure: Evaluate the effectiveness of rTMS in the treatment of long-term chronic neuropathic pain (> 6 months)
time frame: Month 6
description: Persistence of at least 30% improvement in pain symptoms on a numerical scale at the end of the sixth month (M6)
intervention type: Device
intervention name: Repetitive Transcranial Magnetic Stimulation (rTMS)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Neuralgia
sharing ipd: No