<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/NCT03237650</url>
  </required_header>
  <id_info>
    <org_study_id>PCES-Hab</org_study_id>
    <nct_id>NCT03237650</nct_id>
  </id_info>
  <brief_title>Conditioned Pain Modulation Using Painful Cutaneous Electrical Stimulation or Simply Habituation?</brief_title>
  <official_title>Conditioned Pain Modulation Using Painful Cutaneous Electrical Stimulation or Simply Habituation?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruhr University of Bochum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruhr University of Bochum</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>
      Painful cutaneous electrical stimulation (PCES) and corresponding evoked potentials led to a&#xD;
      significant pain relief and decrease of evoked potentials and has been used to analyze&#xD;
      conditioned pain modulation (CPM). However, it is unknown whether the pain relief results&#xD;
      from habituation to the repeated painful electric stimulation. We compared the effects of CPM&#xD;
      and habituation on PCES-induced pain and PCES-evoked potentials and analyzed whether&#xD;
      increased attention by a random change of electric intensities amplifies the habituation&#xD;
      effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>pain relief</measure>
    <time_frame>during the measurement</time_frame>
    <description>pain intensity of painful cutaneous electrical stimulation on a numeric rating scale (NRS 0-100)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>N1P1-amplitude</measure>
    <time_frame>during the measurement</time_frame>
    <description>Amplitudes of painful cutaneous electrical stimulation evoked potentials in µV</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>N1-latency</measure>
    <time_frame>during the measurement</time_frame>
    <description>Latency of the peak N1 of painful cutaneous electrical stimulation evoked potentials in msec</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>P0N1-amplitude</measure>
    <time_frame>during the measurement</time_frame>
    <description>Amplitudes of painful cutaneous electrical stimulation evoked potentials in µV</description>
  </secondary_outcome>
  <enrollment type="Actual">33</enrollment>
  <condition>Habituation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        healthy subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any kind of disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christoph Maier, Prof Dr med</last_name>
    <role>Principal Investigator</role>
    <affiliation>University clinic Bergmannsheil Bochum gGmbH, Department of pain medicine</affiliation>
  </overall_official>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 30, 2017</study_first_submitted>
  <study_first_submitted_qc>July 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>July 30, 2017</last_update_submitted>
  <last_update_submitted_qc>July 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruhr University of Bochum</investigator_affiliation>
    <investigator_full_name>Christoph Maier, Prof. Dr.</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <keyword>Painful cutaneous electrical stimulation</keyword>
  <keyword>Conditioned Pain Modulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</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/NCT03237650
org study id: PCES-Hab
nct id: NCT03237650
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Painful cutaneous electrical stimulation (PCES) and corresponding evoked potentials led to a
      significant pain relief and decrease of evoked potentials and has been used to analyze
      conditioned pain modulation (CPM). However, it is unknown whether the pain relief results
      from habituation to the repeated painful electric stimulation. We compared the effects of CPM
      and habituation on PCES-induced pain and PCES-evoked potentials and analyzed whether
      increased attention by a random change of electric intensities amplifies the habituation
      effects.
observational model: Case-Crossover
time perspective: Cross-Sectional
measure: pain relief
time frame: during the measurement
description: pain intensity of painful cutaneous electrical stimulation on a numeric rating scale (NRS 0-100)
measure: N1P1-amplitude
time frame: during the measurement
description: Amplitudes of painful cutaneous electrical stimulation evoked potentials in µV
measure: N1-latency
time frame: during the measurement
description: Latency of the peak N1 of painful cutaneous electrical stimulation evoked potentials in msec
measure: P0N1-amplitude
time frame: during the measurement
description: Amplitudes of painful cutaneous electrical stimulation evoked potentials in µV
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christoph Maier, Prof Dr med
role: Principal Investigator
affiliation: University clinic Bergmannsheil Bochum gGmbH, Department of pain medicine
responsible party type: Principal Investigator
investigator affiliation: Ruhr University of Bochum
investigator full name: Christoph Maier, Prof. Dr.
investigator title: Prof. Dr. med.
mesh term: Substance-Related Disorders
sharing ipd: No