<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/NCT02242058</url>
  </required_header>
  <id_info>
    <org_study_id>QST-Pupillo3614</org_study_id>
    <nct_id>NCT02242058</nct_id>
  </id_info>
  <brief_title>QST-Pupillometry in Sickle Cell Disease Patients</brief_title>
  <acronym>QST</acronym>
  <official_title>Quantitative Sensory Testing and Pupillometry in Sickle Cell Disease Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Julia Finkel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's National Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There has been little progress for effective treatment of pain in sickle cell disease (SCD)&#xD;
      patients. Many organizations have recognized that understanding the causes and reducing the&#xD;
      burden of pain in SCD is critical in order to improve the quality of life in SCD patients. As&#xD;
      patients with SCD face the challenge of living with both acute and chronic pain which is&#xD;
      often improperly treated, our translational and interdisciplinary project aims to identify&#xD;
      objective measures of pain sensitivity and its biochemical and genetic correlates. We&#xD;
      hypothesize that SCD patients will have decreased tolerance to thermal and electrical&#xD;
      stimuli.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">November 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measuring thermal responsiveness (perception and tolerance) in the outpatient groups.</measure>
    <time_frame>change between baseline and at 90day follow-up</time_frame>
    <description>Using a TSA (thermal sensory analyzer), the patients hot and cold perception and tolerance will be measured in the outpatient groups (high-pain and low-pain frequency and controls).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measuring thermal responsiveness (perception and tolerance) in the inpatient groups.</measure>
    <time_frame>change over 8 consecutive days</time_frame>
    <description>Using a TSA thermal sensory analyzer, the patients hot and cold perception and tolerance will be measured in the inpatient groups (pain crisis and pain service).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure mechanical responsiveness in outpatient groups.</measure>
    <time_frame>change between baseline and 90 day follow-up</time_frame>
    <description>Using the Wagner PPIX 50 Pressure device, patient's tolerance to pressure is assessed in the outpatient groups (high-pain and low-pain frequency and controls).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure mechanical responsiveness in inpatient groups.</measure>
    <time_frame>change over 8 consecutive days</time_frame>
    <description>Using the Wagner PPIX 50 Pressure device, patient's tolerance to pressure is assessed in the inpatient groups (pain crisis and pain service).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measuring the pupil responsiveness in outpatient groups.</measure>
    <time_frame>change between baseline and 90 day follow-up</time_frame>
    <description>Using the Pupillometer device, pupil responses are assessed in the outpatient groups (high-pain and low-pain frequency and controls).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measuring the pupil responsiveness in inpatient groups.</measure>
    <time_frame>change over 8 consecutive days</time_frame>
    <description>Using the Pupillometer device, pupil responses are assessed in the inpatient groups (pain service and pain crisis).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measuring electrical sensitivity in outpatient groups.</measure>
    <time_frame>change between baseline and at 90day follow-up</time_frame>
    <description>Using the Neurometer device, to assess electrical sensory perception and tolerance in the outpatient groups (high-pain and low-pain frequency and control).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measuring electrical sensitivity in inpatient groups.</measure>
    <time_frame>change over 8 consecutive days</time_frame>
    <description>Using the Neurometer device, to assess electrical sensory perception and tolerance in the outpatient groups (pain service and pain crisis).</description>
  </primary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">96</enrollment>
  <condition>SCD With Severe Phenotype (HbSS, HbSβ0 Thalassemia, HbSOARab)</condition>
  <arm_group>
    <arm_group_label>High frequency pain group</arm_group_label>
    <description>39 pediatric or adult patients with high pain frequency (greater than or equal to 3 ER visits and/or hospitalizations for pain per year over the last two years)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Pain Frequency group</arm_group_label>
    <description>39 pediatric or adult patients with low pain frequency (less than or equal to 1 severe pain episode for the last two years)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control group</arm_group_label>
    <description>39 pediatric or adult relatives of sickle cell disease patients, who do not have the sickle cell trait of SCD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pain Crisis group</arm_group_label>
    <description>30 patients with sickle cell disease with severe phenotype (HbSS, HbSβ0 thalassemia, HbSOArab)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pain Service group</arm_group_label>
    <description>10 patients without sickle cell disease admitted to the pain service.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quantitative sensory testing</intervention_name>
    <arm_group_label>Healthy control group</arm_group_label>
    <arm_group_label>High frequency pain group</arm_group_label>
    <arm_group_label>Low Pain Frequency group</arm_group_label>
    <arm_group_label>Pain Crisis group</arm_group_label>
    <arm_group_label>Pain Service group</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Collection of blood samples at baseline to be stored in the Pain Neurobiology laboratory for&#xD;
      future biochemical studies.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        SCD patients referred to the Pain Medicine clinic, either outpatient or inpatient.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  SCD with severe phenotype (HbSS, HbSbeta0 thalassemia, HbSOArab)&#xD;
&#xD;
          -  Relatives of SCD patients who do not have sickle cell trait or SCD; healthy controls&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Completed overt clinical stroke or transient ischemic attack;&#xD;
&#xD;
          -  Known severe vasculopathy or Moyamoya disease on brain MRA (Magnetic Resonance&#xD;
             Angiography).&#xD;
&#xD;
          -  history of having consumed alcohol within the last 12 hours prior to testing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julia Finkel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's National Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's National Health System</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's National Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 13, 2013</study_first_submitted>
  <study_first_submitted_qc>September 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>January 17, 2020</last_update_submitted>
  <last_update_submitted_qc>January 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Children's National Research Institute</investigator_affiliation>
    <investigator_full_name>Julia Finkel</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</mesh_term>
    <mesh_term>Thalassemia</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/NCT02242058
org study id: QST-Pupillo3614
nct id: NCT02242058
lead sponsor: 
has dmc: Yes
There has been little progress for effective treatment of pain in sickle cell disease (SCD)
      patients. Many organizations have recognized that understanding the causes and reducing the
      burden of pain in SCD is critical in order to improve the quality of life in SCD patients. As
      patients with SCD face the challenge of living with both acute and chronic pain which is
      often improperly treated, our translational and interdisciplinary project aims to identify
      objective measures of pain sensitivity and its biochemical and genetic correlates. We
      hypothesize that SCD patients will have decreased tolerance to thermal and electrical
      stimuli.
observational model: Case-Control
time perspective: Prospective
measure: Measuring thermal responsiveness (perception and tolerance) in the outpatient groups.
time frame: change between baseline and at 90day follow-up
description: Using a TSA (thermal sensory analyzer), the patients hot and cold perception and tolerance will be measured in the outpatient groups (high-pain and low-pain frequency and controls).
measure: Measuring thermal responsiveness (perception and tolerance) in the inpatient groups.
time frame: change over 8 consecutive days
description: Using a TSA thermal sensory analyzer, the patients hot and cold perception and tolerance will be measured in the inpatient groups (pain crisis and pain service).
measure: Measure mechanical responsiveness in outpatient groups.
time frame: change between baseline and 90 day follow-up
description: Using the Wagner PPIX 50 Pressure device, patient's tolerance to pressure is assessed in the outpatient groups (high-pain and low-pain frequency and controls).
measure: Measure mechanical responsiveness in inpatient groups.
time frame: change over 8 consecutive days
description: Using the Wagner PPIX 50 Pressure device, patient's tolerance to pressure is assessed in the inpatient groups (pain crisis and pain service).
measure: Measuring the pupil responsiveness in outpatient groups.
time frame: change between baseline and 90 day follow-up
description: Using the Pupillometer device, pupil responses are assessed in the outpatient groups (high-pain and low-pain frequency and controls).
measure: Measuring the pupil responsiveness in inpatient groups.
time frame: change over 8 consecutive days
description: Using the Pupillometer device, pupil responses are assessed in the inpatient groups (pain service and pain crisis).
measure: Measuring electrical sensitivity in outpatient groups.
time frame: change between baseline and at 90day follow-up
description: Using the Neurometer device, to assess electrical sensory perception and tolerance in the outpatient groups (high-pain and low-pain frequency and control).
measure: Measuring electrical sensitivity in inpatient groups.
time frame: change over 8 consecutive days
description: Using the Neurometer device, to assess electrical sensory perception and tolerance in the outpatient groups (pain service and pain crisis).
arm group label: High frequency pain group
description: 39 pediatric or adult patients with high pain frequency (greater than or equal to 3 ER visits and/or hospitalizations for pain per year over the last two years)
arm group label: Low Pain Frequency group
description: 39 pediatric or adult patients with low pain frequency (less than or equal to 1 severe pain episode for the last two years)
arm group label: Healthy control group
description: 39 pediatric or adult relatives of sickle cell disease patients, who do not have the sickle cell trait of SCD.
arm group label: Pain Crisis group
description: 30 patients with sickle cell disease with severe phenotype (HbSS, HbSβ0 thalassemia, HbSOArab)
arm group label: Pain Service group
description: 10 patients without sickle cell disease admitted to the pain service.
intervention type: Other
intervention name: Quantitative sensory testing
arm group label: Healthy control group
arm group label: High frequency pain group
arm group label: Low Pain Frequency group
arm group label: Pain Crisis group
arm group label: Pain Service group
Collection of blood samples at baseline to be stored in the Pain Neurobiology laboratory for
      future biochemical studies.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 13 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Julia Finkel, MD
role: Principal Investigator
affiliation: Children's National Health System
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Children's National Research Institute
investigator full name: Julia Finkel
investigator title: Principal Investigator
mesh term: Anemia, Sickle Cell
mesh term: Thalassemia