<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/NCT02987933</url>
  </required_header>
  <id_info>
    <org_study_id>BSI001</org_study_id>
    <nct_id>NCT02987933</nct_id>
  </id_info>
  <brief_title>The Use of Resting State, fMRI and DTI in the Identification of Chronic Pain Conditions</brief_title>
  <official_title>The Use of Resting State, fMRI and DTI in the Identification of Chronic Pain Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brain Scan Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>State University of New York at Buffalo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brain Scan Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Resting state fMRI scans of chronic pain sufferers will be compared to those of healthy&#xD;
      normals and may be sufficiently different to allow a high level of classification accuracy of&#xD;
      whether subjects have chronic pain. In addition, investigators will utilize DTI and a brief&#xD;
      activation state using pain rumination to assess whether investigators can reliably find&#xD;
      differences between chronic pain sufferers and healthy normals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Resting state fMRI scans of chronic pain sufferers may be sufficiently different from scans&#xD;
      of normal subjects to allow a high level of classification accuracy of whether subjects have&#xD;
      chronic pain. In addition, investigators will utilize DTI and a brief activation state using&#xD;
      pain rumination to assess whether investigators can reliably find differences between chronic&#xD;
      pain sufferers and healthy normals. The analysis will use pattern recognition methods in a&#xD;
      leave N out cross validation design. The success of the classifications will be the mean of&#xD;
      all the validation runs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2017</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>Functional brain connectivity</measure>
    <time_frame>6 months</time_frame>
    <description>Assessed by fMRI</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Chronic Pain</arm_group_label>
    <description>Adults, &gt; 6 months duration, daily pain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Normals</arm_group_label>
    <description>Age and gender matched controls</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with daily chronic pain (&gt; 6 months)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Daily Pain lasting for more than 6 months. Ages eligible for study are between 20 and 70&#xD;
        years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Adults unable to consent Children, teenagers Pregnant women Prisoners Subjects who do not&#xD;
        know English MRI exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David S Wack, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University at Buffalo: SUNY</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David S Wack, Ph.D.</last_name>
    <phone>716-838-5889</phone>
    <phone_ext>152</phone_ext>
    <email>dswack@buffalo.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>David T Corey, Ph.D.</last_name>
    <phone>855-822-7226</phone>
    <email>dcorey@brainscaninc.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>WNY MRI</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David S Wack, Ph.D.</last_name>
      <phone>716-838-5889</phone>
      <phone_ext>152</phone_ext>
      <email>dswack@buffalo.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Napadow V, LaCount L, Park K, As-Sanie S, Clauw DJ, Harris RE. Intrinsic brain connectivity in fibromyalgia is associated with chronic pain intensity. Arthritis Rheum. 2010 Aug;62(8):2545-55. doi: 10.1002/art.27497.</citation>
    <PMID>20506181</PMID>
  </reference>
  <reference>
    <citation>Kucyi A, Moayedi M, Weissman-Fogel I, Goldberg MB, Freeman BV, Tenenbaum HC, Davis KD. Enhanced medial prefrontal-default mode network functional connectivity in chronic pain and its association with pain rumination. J Neurosci. 2014 Mar 12;34(11):3969-75. doi: 10.1523/JNEUROSCI.5055-13.2014.</citation>
    <PMID>24623774</PMID>
  </reference>
  <reference>
    <citation>Baliki MN, Geha PY, Apkarian AV, Chialvo DR. Beyond feeling: chronic pain hurts the brain, disrupting the default-mode network dynamics. J Neurosci. 2008 Feb 6;28(6):1398-403. doi: 10.1523/JNEUROSCI.4123-07.2008.</citation>
    <PMID>18256259</PMID>
  </reference>
  <reference>
    <citation>Boeckle M, Schrimpf M, Liegl G, Pieh C. Neural correlates of somatoform disorders from a meta-analytic perspective on neuroimaging studies. Neuroimage Clin. 2016 Apr 10;11:606-613. doi: 10.1016/j.nicl.2016.04.001. eCollection 2016.</citation>
    <PMID>27182487</PMID>
  </reference>
  <reference>
    <citation>Tagliazucchi E, Balenzuela P, Fraiman D, Chialvo DR. Brain resting state is disrupted in chronic back pain patients. Neurosci Lett. 2010 Nov 12;485(1):26-31. doi: 10.1016/j.neulet.2010.08.053. Epub 2010 Aug 26.</citation>
    <PMID>20800649</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Pain</keyword>
  <keyword>fMRI</keyword>
  <keyword>DTI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</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/NCT02987933
org study id: BSI001
nct id: NCT02987933
lead sponsor: 
collaborator: 
has dmc: No
Resting state fMRI scans of chronic pain sufferers will be compared to those of healthy
      normals and may be sufficiently different to allow a high level of classification accuracy of
      whether subjects have chronic pain. In addition, investigators will utilize DTI and a brief
      activation state using pain rumination to assess whether investigators can reliably find
      differences between chronic pain sufferers and healthy normals.
Resting state fMRI scans of chronic pain sufferers may be sufficiently different from scans
      of normal subjects to allow a high level of classification accuracy of whether subjects have
      chronic pain. In addition, investigators will utilize DTI and a brief activation state using
      pain rumination to assess whether investigators can reliably find differences between chronic
      pain sufferers and healthy normals. The analysis will use pattern recognition methods in a
      leave N out cross validation design. The success of the classifications will be the mean of
      all the validation runs.
observational model: Case-Control
time perspective: Prospective
measure: Functional brain connectivity
time frame: 6 months
description: Assessed by fMRI
arm group label: Chronic Pain
description: Adults, > 6 months duration, daily pain
arm group label: Healthy Normals
description: Age and gender matched controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David S Wack, Ph.D.
role: Principal Investigator
affiliation: University at Buffalo: SUNY
last name: David S Wack, Ph.D.
phone: 716-838-5889
phone ext: 152
email: dswack@buffalo.edu
last name: David T Corey, Ph.D.
phone: 855-822-7226
email: dcorey@brainscaninc.ca
facility: 
status: Recruiting
contact: 
country: United States
citation: Napadow V, LaCount L, Park K, As-Sanie S, Clauw DJ, Harris RE. Intrinsic brain connectivity in fibromyalgia is associated with chronic pain intensity. Arthritis Rheum. 2010 Aug;62(8):2545-55. doi: 10.1002/art.27497.
PMID: 20506181
citation: Kucyi A, Moayedi M, Weissman-Fogel I, Goldberg MB, Freeman BV, Tenenbaum HC, Davis KD. Enhanced medial prefrontal-default mode network functional connectivity in chronic pain and its association with pain rumination. J Neurosci. 2014 Mar 12;34(11):3969-75. doi: 10.1523/JNEUROSCI.5055-13.2014.
PMID: 24623774
citation: Baliki MN, Geha PY, Apkarian AV, Chialvo DR. Beyond feeling: chronic pain hurts the brain, disrupting the default-mode network dynamics. J Neurosci. 2008 Feb 6;28(6):1398-403. doi: 10.1523/JNEUROSCI.4123-07.2008.
PMID: 18256259
citation: Boeckle M, Schrimpf M, Liegl G, Pieh C. Neural correlates of somatoform disorders from a meta-analytic perspective on neuroimaging studies. Neuroimage Clin. 2016 Apr 10;11:606-613. doi: 10.1016/j.nicl.2016.04.001. eCollection 2016.
PMID: 27182487
citation: Tagliazucchi E, Balenzuela P, Fraiman D, Chialvo DR. Brain resting state is disrupted in chronic back pain patients. Neurosci Lett. 2010 Nov 12;485(1):26-31. doi: 10.1016/j.neulet.2010.08.053. Epub 2010 Aug 26.
PMID: 20800649
responsible party type: Sponsor
mesh term: Chronic Pain
sharing ipd: No