<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/NCT02985294</url>
  </required_header>
  <id_info>
    <org_study_id>Neuroscience Technologies</org_study_id>
    <nct_id>NCT02985294</nct_id>
  </id_info>
  <brief_title>Peripheral Physiological Measures as Determinants of Pain Risk</brief_title>
  <acronym>DOLORiskWP51</acronym>
  <official_title>DOLORisk: Understanding Risk Factors and Determinants for Neuropathic Pain - Peripheral Physiological Measures as Determinants of Pain Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neuroscience Technologies SLP, Barcelona</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Dundee</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Neuroscience Technologies SLP, Barcelona</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates peripheral nervous system function using Multiple Excitability Measures&#xD;
      (MEM) to obtain &quot;electrophysiological pain phenotypes&quot;&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using MEM for peripheral sensory and motor axons we want to identify a set of excitability&#xD;
      measures that:&#xD;
&#xD;
        1. Correlate with parameters of clinical pain and of pain processing in existing pain&#xD;
           patients (cross sectional study), with the aim to obtain an objective Pain Biomarker.&#xD;
&#xD;
        2. Predict development of neuropathic pain in susceptible patients (longitudinal study).&#xD;
           Neuropathic Pain Predictor for patients:&#xD;
&#xD;
      i. Undergoing surgical procedures associated with a relatively high risk of developing&#xD;
      neuropathic pain such as thoracotomy and hernia repair ii. Planning to start chemotherapy&#xD;
      with potentially neurotoxic agents such as vincristine&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2016</start_date>
  <completion_date type="Anticipated">April 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Electrophysiological pain phenotypes using MEM. Pain biomarker</measure>
    <time_frame>Single assessment (cross sectional study) at the first and only visit</time_frame>
    <description>Correlate with parameters of clinical pain and of pain processing in existing pain patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Electrophysiological pain phenotypes using MEM. Pain predictor</measure>
    <time_frame>Single assessment at baseline, before any procedure (surgery/chemotherapy)</time_frame>
    <description>Predict development of neuropathic pain in susceptible patients</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Polyneuropathies</condition>
  <condition>Peripheral Nerve Injuries</condition>
  <condition>Peripheral Nervous System Diseases</condition>
  <condition>Chemotherapy Effects</condition>
  <condition>Neuralgia</condition>
  <arm_group>
    <arm_group_label>Cross-sectional cohort</arm_group_label>
    <description>Multiple Excitability Measures of peripheral nerves on patients with chronic peripheral neuropathic pain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Longitudinal cohort</arm_group_label>
    <description>Multiple Excitability Measures of peripheral nerves on painless patients before and after potential chronic neuropathic pain-inducing interventions (chemotherapy, surgery)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multiple Excitability Measures of peripheral nerves</intervention_name>
    <description>The technique of threshold tracking can be used to obtain several measures of peripheral nerve excitability (Multiple Excitability Measures or MEM), such as refractoriness, supernormality, strength-duration time constant and 'threshold electrotonus' (i.e. the changes in threshold produced by long-lasting depolarizing or hyperpolarizing current pulses). Each of these measurements depends on membrane potential and on other biophysical properties of the axons. Many of these excitability parameters are very constant among different subjects, while other, such as the current/threshold parameters and the super/sub-excitability parameters, appear to be characteristic of an individual</description>
    <arm_group_label>Cross-sectional cohort</arm_group_label>
    <arm_group_label>Longitudinal cohort</arm_group_label>
    <other_name>Assessment of sensory phenotype by QST (quantitative sensory testing)</other_name>
    <other_name>Questionnaires</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        1. Painless patients and patients with chronic peripheral neuropathic pain&#xD;
&#xD;
          2. Susceptible patients for developing pain i. Undergoing surgical procedures associated&#xD;
             with a relatively high risk of developing neuropathic pain such as thoracotomy and&#xD;
             hernia repair ii. Planning to start chemotherapy with potentially neurotoxic agents&#xD;
             such as taxol, vincristine, etc.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic peripheral neuropathic pain&#xD;
&#xD;
          -  Painless Patient with risk to develop neuropathic pain (post-surgery,&#xD;
             chemotherapy-induced)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minors&#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_contact>
    <last_name>Romà Solà, MD</last_name>
    <phone>0034 934020164</phone>
    <email>rsola@nsc-tec.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Neuroscience technologies</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Romà Solà, MD</last_name>
      <phone>0034 93 4020164</phone>
      <email>rsola@nsc-tec.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://dolorisk.eu/</url>
    <description>Official Consortium web site</description>
  </link>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>August 21, 2018</last_update_submitted>
  <last_update_submitted_qc>August 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neuropathic pain</keyword>
  <keyword>Quantitative Sensory Testing</keyword>
  <keyword>Multiple Excitability Measures</keyword>
  <keyword>Threshold Tracking</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Polyneuropathies</mesh_term>
    <mesh_term>Peripheral Nerve Injuries</mesh_term>
    <mesh_term>Peripheral Nervous System Diseases</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/NCT02985294
org study id: Neuroscience Technologies
nct id: NCT02985294
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This study evaluates peripheral nervous system function using Multiple Excitability Measures
      (MEM) to obtain "electrophysiological pain phenotypes"
Using MEM for peripheral sensory and motor axons we want to identify a set of excitability
      measures that:

        1. Correlate with parameters of clinical pain and of pain processing in existing pain
           patients (cross sectional study), with the aim to obtain an objective Pain Biomarker.

        2. Predict development of neuropathic pain in susceptible patients (longitudinal study).
           Neuropathic Pain Predictor for patients:

      i. Undergoing surgical procedures associated with a relatively high risk of developing
      neuropathic pain such as thoracotomy and hernia repair ii. Planning to start chemotherapy
      with potentially neurotoxic agents such as vincristine
observational model: Cohort
time perspective: Prospective
measure: Electrophysiological pain phenotypes using MEM. Pain biomarker
time frame: Single assessment (cross sectional study) at the first and only visit
description: Correlate with parameters of clinical pain and of pain processing in existing pain patients
measure: Electrophysiological pain phenotypes using MEM. Pain predictor
time frame: Single assessment at baseline, before any procedure (surgery/chemotherapy)
description: Predict development of neuropathic pain in susceptible patients
arm group label: Cross-sectional cohort
description: Multiple Excitability Measures of peripheral nerves on patients with chronic peripheral neuropathic pain
arm group label: Longitudinal cohort
description: Multiple Excitability Measures of peripheral nerves on painless patients before and after potential chronic neuropathic pain-inducing interventions (chemotherapy, surgery)
intervention type: Other
intervention name: Multiple Excitability Measures of peripheral nerves
description: The technique of threshold tracking can be used to obtain several measures of peripheral nerve excitability (Multiple Excitability Measures or MEM), such as refractoriness, supernormality, strength-duration time constant and 'threshold electrotonus' (i.e. the changes in threshold produced by long-lasting depolarizing or hyperpolarizing current pulses). Each of these measurements depends on membrane potential and on other biophysical properties of the axons. Many of these excitability parameters are very constant among different subjects, while other, such as the current/threshold parameters and the super/sub-excitability parameters, appear to be characteristic of an individual
arm group label: Cross-sectional cohort
arm group label: Longitudinal cohort
other name: Assessment of sensory phenotype by QST (quantitative sensory testing)
other name: Questionnaires
blood sample
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Romà Solà, MD
phone: 0034 934020164
email: rsola@nsc-tec.com
facility: 
status: Recruiting
contact: 
country: Spain
url: http://dolorisk.eu/
description: Official Consortium web site
responsible party type: Sponsor
mesh term: Neuralgia
mesh term: Nervous System Diseases
mesh term: Polyneuropathies
mesh term: Peripheral Nerve Injuries
mesh term: Peripheral Nervous System Diseases
sharing ipd: No