<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/NCT03003715</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00024607</org_study_id>
    <nct_id>NCT03003715</nct_id>
  </id_info>
  <brief_title>Brain as a Therapeutic and Research Target in Trigeminal Neuropathic Pain</brief_title>
  <official_title>Brain as a Therapeutic and Research Target in Trigeminal Neuropathic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main goal of this study to integrate techniques producing images of the brain (also&#xD;
      called neuroimaging techniques) with non-invasive brain stimulation to investigate factors&#xD;
      that may be associated with chronic pain in patients with Trigeminal Neuropathic Pain (TNP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Trigeminal neuropathic pain (TNP) disorders, such as classical trigeminal and post-surgical&#xD;
      neuralgia, are debilitating chronic conditions with pain that is either spontaneous or that&#xD;
      can be intensely evoked by light touch to the facial skin. Although neuroimaging techniques&#xD;
      have provided insights into some brain mechanisms of experimental trigeminal pain in humans&#xD;
      (DaSilva et al., 2002; Borsook et al., 2003), it is not well understood how structural and&#xD;
      molecular mechanisms are affected during the course of TNP, and how they can be safely&#xD;
      modulated for therapeutic and research purposes. Understanding these processes is crucial to&#xD;
      determine the structures engaged in the development and persistence of TNP.&#xD;
&#xD;
      We will test the hypothesis that chronicity of TNP is sustained by changes at cellular and&#xD;
      molecular levels in neural circuits associated with pain perception and modulation, rather&#xD;
      than by the initial peripheral etiology, and that this dysfunction can be safely targeted and&#xD;
      modulated as a therapeutic approach by transcranial direct current stimulation (tDCS). To&#xD;
      achieve this goal we will use a neuroimaging technique, PET, employing a mathematical model&#xD;
      that permits the quantification of opioid receptor availability in vivo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in MOR BPND levels</measure>
    <time_frame>place weeks after not more than 6months</time_frame>
    <description>change from baseline to versus sham or active tDCS</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Trigeminal Neuropathic Pain</condition>
  <arm_group>
    <arm_group_label>Refractory Trigeminal Neurpathic Pain (TNP) Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients receive QST prior to PET scan used to obtain baseline measures, then placebo tDCS, followed by QST and Active tDCS, over the course of a 90 minute PET scan; QST is used again to take final measurements 30 minutes later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All volunteers receive QST prior to PET scan used to obtain baseline measures, then placebo tDCS, followed by QST and Active tDCS, over the course of a 90 minute PET scan; QST is used again to take final measurements 30 minutes later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PET Scans</intervention_name>
    <description>Two 90 minute scans whose maximum radiological dose is 15 mCi [11 C] carfentanil, a selective and specific mu-opioid receptor radioligand. The first one provided baseline data, and the second occurred with the sequence of sham tDCS and tDCS as described in each arm description.</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Refractory Trigeminal Neurpathic Pain (TNP) Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>transcranial direct current stimulation (tDCS)</intervention_name>
    <description>In active tDCS, a 2 milli-amp transcranial direct current stimulation is for 20 minutes.</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Refractory Trigeminal Neurpathic Pain (TNP) Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>No radiotracer is used; 3 tesla scanner; all participants have MRI prior to PET scans.</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Refractory Trigeminal Neurpathic Pain (TNP) Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sham tDCS (prior to real tDCS)</intervention_name>
    <description>For sham tDCS, current is applied only for 30 seconds, as sensations arising from tDCS treatment occur only at the beginning of application; however the equipment will be on the participant for 20 minutes to match that of the active tDCS application.</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Refractory Trigeminal Neurpathic Pain (TNP) Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patient Inclusion Criteria:&#xD;
&#xD;
          -  Daily chronic TNP for at least 6 months not adequately controlled by pervious medicine&#xD;
             therapies;&#xD;
&#xD;
          -  minimal average baseline pain score of 4 (moderate to severe) in the visual analogue&#xD;
             scale (VAS);&#xD;
&#xD;
          -  unilateral pain&#xD;
&#xD;
          -  orofacial allodynic region to mechanical (light touch or palpation) or thermal&#xD;
             stimulation (head or cold);&#xD;
&#xD;
        Patient Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy or planning to become pregnant&#xD;
&#xD;
          -  local pathology (e.g. orofacial lesion)&#xD;
&#xD;
          -  history of systemic disorders (e.g. MS)&#xD;
&#xD;
          -  history of other chronic pain disorder (e.g. back pain)&#xD;
&#xD;
          -  recent orofacial surgery or trauma (&lt; 6 months)&#xD;
&#xD;
          -  history of central origin disorders (e.g. stroke)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandre F DaSilva, DMedSci</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>November 21, 2017</last_update_submitted>
  <last_update_submitted_qc>November 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Alexandre DaSilva, DDS, MS</investigator_full_name>
    <investigator_title>DDS, D.Med.Sc.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</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/NCT03003715
org study id: HUM00024607
nct id: NCT03003715
lead sponsor: 
has dmc: Yes
The main goal of this study to integrate techniques producing images of the brain (also
      called neuroimaging techniques) with non-invasive brain stimulation to investigate factors
      that may be associated with chronic pain in patients with Trigeminal Neuropathic Pain (TNP).
Trigeminal neuropathic pain (TNP) disorders, such as classical trigeminal and post-surgical
      neuralgia, are debilitating chronic conditions with pain that is either spontaneous or that
      can be intensely evoked by light touch to the facial skin. Although neuroimaging techniques
      have provided insights into some brain mechanisms of experimental trigeminal pain in humans
      (DaSilva et al., 2002; Borsook et al., 2003), it is not well understood how structural and
      molecular mechanisms are affected during the course of TNP, and how they can be safely
      modulated for therapeutic and research purposes. Understanding these processes is crucial to
      determine the structures engaged in the development and persistence of TNP.

      We will test the hypothesis that chronicity of TNP is sustained by changes at cellular and
      molecular levels in neural circuits associated with pain perception and modulation, rather
      than by the initial peripheral etiology, and that this dysfunction can be safely targeted and
      modulated as a therapeutic approach by transcranial direct current stimulation (tDCS). To
      achieve this goal we will use a neuroimaging technique, PET, employing a mathematical model
      that permits the quantification of opioid receptor availability in vivo.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in MOR BPND levels
time frame: place weeks after not more than 6months
description: change from baseline to versus sham or active tDCS
arm group label: Refractory Trigeminal Neurpathic Pain (TNP) Patients
arm group type: Experimental
description: All patients receive QST prior to PET scan used to obtain baseline measures, then placebo tDCS, followed by QST and Active tDCS, over the course of a 90 minute PET scan; QST is used again to take final measurements 30 minutes later.
arm group label: Healthy volunteers
arm group type: Experimental
description: All volunteers receive QST prior to PET scan used to obtain baseline measures, then placebo tDCS, followed by QST and Active tDCS, over the course of a 90 minute PET scan; QST is used again to take final measurements 30 minutes later.
intervention type: Procedure
intervention name: PET Scans
description: Two 90 minute scans whose maximum radiological dose is 15 mCi [11 C] carfentanil, a selective and specific mu-opioid receptor radioligand. The first one provided baseline data, and the second occurred with the sequence of sham tDCS and tDCS as described in each arm description.
arm group label: Healthy volunteers
arm group label: Refractory Trigeminal Neurpathic Pain (TNP) Patients
intervention type: Procedure
intervention name: transcranial direct current stimulation (tDCS)
description: In active tDCS, a 2 milli-amp transcranial direct current stimulation is for 20 minutes.
arm group label: Healthy volunteers
arm group label: Refractory Trigeminal Neurpathic Pain (TNP) Patients
intervention type: Procedure
intervention name: MRI
description: No radiotracer is used; 3 tesla scanner; all participants have MRI prior to PET scans.
arm group label: Healthy volunteers
arm group label: Refractory Trigeminal Neurpathic Pain (TNP) Patients
intervention type: Other
intervention name: sham tDCS (prior to real tDCS)
description: For sham tDCS, current is applied only for 30 seconds, as sensations arising from tDCS treatment occur only at the beginning of application; however the equipment will be on the participant for 20 minutes to match that of the active tDCS application.
arm group label: Healthy volunteers
arm group label: Refractory Trigeminal Neurpathic Pain (TNP) Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alexandre F DaSilva, DMedSci
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Alexandre DaSilva, DDS, MS
investigator title: DDS, D.Med.Sc.
mesh term: Neuralgia