<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/NCT03280238</url>
  </required_header>
  <id_info>
    <org_study_id>2016/278</org_study_id>
    <nct_id>NCT03280238</nct_id>
  </id_info>
  <brief_title>Pupil Dilation and Analgesia Nociception Index</brief_title>
  <official_title>Do Pupil Dilation and Analgesia Nociception Index Reflect Pain: a Pilot Study in Healthy, Conscious Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vrije Universiteit Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vrije Universiteit Brussel</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pain assessment is crucial in clinical practice. Currently, subjective self-report is&#xD;
      considered the most appropriate method to evaluate pain. Although several methods to assess&#xD;
      pain objectively exist, the lack of a golden standard still remains. This pilot study&#xD;
      assesses the changes in pupil dilation (PD) and the analgesia nociception index (ANI) as a&#xD;
      measure of pain in healthy, conscious, male volunteers in a highly standardized and&#xD;
      individualized environment. Nineteen subjects received three blocks of 4 individualized&#xD;
      electrical stimulus intensities, ranging from no to severe pain. Subjects reported their&#xD;
      perceived severity of each individual stimulus, enabling the comparison of changes in PD and&#xD;
      ANI in relation to both administered stimulus intensities and perceived pain severities. PD&#xD;
      and ANI were measured before and after each administration of a stimulus.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pupil dilation in relation to pain</measure>
    <time_frame>2sec before until 4sec after each painful stimulus</time_frame>
    <description>measurement of pupil dilation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analgesia nociception index in relation to pain</measure>
    <time_frame>30sec before until 60sec after each painful stimulus</time_frame>
    <description>measurement of analgesia nociception index</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Experiment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individualized painful electrical stimuli, Surpass LT stimulator (EMS Biomedical, Korneuburg, Austria) with a bipolar felt pad electrode&#xD;
Measurement of pupil diameter, Algiscan® (iDMed, Marseille, France)&#xD;
Measurement of Analgesia Nociception Index, PhysioDoloris® (MetroDoloris, Lille, France)</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Measurement of pupil dilation and analgesia nociception index</intervention_name>
    <description>painful electrical stimuli of various intensities were administered to the subjects after which changes in pupil diameter and analgesia nociception index were measured</description>
    <arm_group_label>Experiment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  good health&#xD;
&#xD;
          -  no acute or chronic pain conditions&#xD;
&#xD;
          -  well rested&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic treatment&#xD;
&#xD;
          -  bad health&#xD;
&#xD;
          -  daily use of analgetics or other medication&#xD;
&#xD;
          -  weekly tobacco use&#xD;
&#xD;
          -  weekly use of recreational drugs&#xD;
&#xD;
          -  more than 10 alcohol consumptions a week&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wendy Van Bogaert, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vrije Universiteit Brussel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Reginald Deschepper, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Vrije Universiteit Brussel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Jette</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.</citation>
    <PMID>8737210</PMID>
  </reference>
  <reference>
    <citation>Chapman CR, Oka S, Bradshaw DH, Jacobson RC, Donaldson GW. Phasic pupil dilation response to noxious stimulation in normal volunteers: relationship to brain evoked potentials and pain report. Psychophysiology. 1999 Jan;36(1):44-52. doi: 10.1017/s0048577299970373.</citation>
    <PMID>10098379</PMID>
  </reference>
  <reference>
    <citation>Koenig J, Jarczok MN, Ellis RJ, Hillecke TK, Thayer JF. Heart rate variability and experimentally induced pain in healthy adults: a systematic review. Eur J Pain. 2014 Mar;18(3):301-14. doi: 10.1002/j.1532-2149.2013.00379.x. Epub 2013 Aug 6.</citation>
    <PMID>23922336</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vrije Universiteit Brussel</investigator_affiliation>
    <investigator_full_name>Wendy Van Bogaert</investigator_full_name>
    <investigator_title>Medical Student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mydriasis</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/NCT03280238
org study id: 2016/278
nct id: NCT03280238
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Pain assessment is crucial in clinical practice. Currently, subjective self-report is
      considered the most appropriate method to evaluate pain. Although several methods to assess
      pain objectively exist, the lack of a golden standard still remains. This pilot study
      assesses the changes in pupil dilation (PD) and the analgesia nociception index (ANI) as a
      measure of pain in healthy, conscious, male volunteers in a highly standardized and
      individualized environment. Nineteen subjects received three blocks of 4 individualized
      electrical stimulus intensities, ranging from no to severe pain. Subjects reported their
      perceived severity of each individual stimulus, enabling the comparison of changes in PD and
      ANI in relation to both administered stimulus intensities and perceived pain severities. PD
      and ANI were measured before and after each administration of a stimulus.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Pupil dilation in relation to pain
time frame: 2sec before until 4sec after each painful stimulus
description: measurement of pupil dilation
measure: Analgesia nociception index in relation to pain
time frame: 30sec before until 60sec after each painful stimulus
description: measurement of analgesia nociception index
arm group label: Experiment
arm group type: Experimental
description: Individualized painful electrical stimuli, Surpass LT stimulator (EMS Biomedical, Korneuburg, Austria) with a bipolar felt pad electrode
Measurement of pupil diameter, Algiscan® (iDMed, Marseille, France)
Measurement of Analgesia Nociception Index, PhysioDoloris® (MetroDoloris, Lille, France)
intervention type: Diagnostic Test
intervention name: Measurement of pupil dilation and analgesia nociception index
description: painful electrical stimuli of various intensities were administered to the subjects after which changes in pupil diameter and analgesia nociception index were measured
arm group label: Experiment
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wendy Van Bogaert, MS
role: Principal Investigator
affiliation: Vrije Universiteit Brussel
last name: Reginald Deschepper, PhD
role: Study Chair
affiliation: Vrije Universiteit Brussel
facility: 
country: Belgium
citation: Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.
PMID: 8737210
citation: Chapman CR, Oka S, Bradshaw DH, Jacobson RC, Donaldson GW. Phasic pupil dilation response to noxious stimulation in normal volunteers: relationship to brain evoked potentials and pain report. Psychophysiology. 1999 Jan;36(1):44-52. doi: 10.1017/s0048577299970373.
PMID: 10098379
citation: Koenig J, Jarczok MN, Ellis RJ, Hillecke TK, Thayer JF. Heart rate variability and experimentally induced pain in healthy adults: a systematic review. Eur J Pain. 2014 Mar;18(3):301-14. doi: 10.1002/j.1532-2149.2013.00379.x. Epub 2013 Aug 6.
PMID: 23922336
responsible party type: Principal Investigator
investigator affiliation: Vrije Universiteit Brussel
investigator full name: Wendy Van Bogaert
investigator title: Medical Student
mesh term: Mydriasis