<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/NCT03305289</url>
  </required_header>
  <id_info>
    <org_study_id>RF in trigeminal neuralgia</org_study_id>
    <nct_id>NCT03305289</nct_id>
  </id_info>
  <brief_title>FMRI Assessment After Radiofrequency in Trigeminal Neuralgia</brief_title>
  <official_title>Brain Activity Assessment by Functional MRI Before, After Radiofrequency of Gasserian Ganglia in Patient With Trigeminal Neuralgia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      To investigate the brain activations related to TN, using fMRI, and to evaluate changes in&#xD;
      these activations following the application of pulsed and thermal Radiofrequency lesioning to&#xD;
      the gasserien ganglion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2020</start_date>
  <completion_date type="Anticipated">October 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain alleviation</measure>
    <time_frame>1 month</time_frame>
    <description>pain assessment by functional MRI</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Trigeminal Neuralgia</condition>
  <condition>Pain, Neuropathic</condition>
  <arm_group>
    <arm_group_label>pulsed radiofrequency</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then pulsed radiofrequency will be applied for 10 patients for 10 mins</description>
  </arm_group>
  <arm_group>
    <arm_group_label>thermal Radiofrequency</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then Thermal lesion will be applied for 10 patients for 2 cycles of 90 seconds</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pulsed Radiofrequency</intervention_name>
    <description>sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then pulsed radiofrequency will be applied for 10 patients for 10 mins</description>
    <arm_group_label>pulsed radiofrequency</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>thermal Radiofrequency</intervention_name>
    <description>sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then Thermal lesion will be applied for 10 patients for 2 cycles of 90 seconds</description>
    <arm_group_label>thermal Radiofrequency</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 20 - 65 years&#xD;
&#xD;
          -  Primary trigeminal neuralgia&#xD;
&#xD;
          -  Maxillary and/or mandibular affection only&#xD;
&#xD;
          -  Failure of medical treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  2ry trigeminal neuralgia&#xD;
&#xD;
          -  Recurrent trigeminal neuralgia&#xD;
&#xD;
          -  Ophthalmic branch affection&#xD;
&#xD;
          -  Contraindication for intervention (sepsis, coagulopathy, infection at entery point,&#xD;
             local anesthetic allergy,…)&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>July 25, 2020</last_update_submitted>
  <last_update_submitted_qc>July 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>mohamed elsayed</investigator_full_name>
    <investigator_title>assisstant lecture</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trigeminal Neuralgia</mesh_term>
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03305289
org study id: RF in trigeminal neuralgia
nct id: NCT03305289
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To investigate the brain activations related to TN, using fMRI, and to evaluate changes in
      these activations following the application of pulsed and thermal Radiofrequency lesioning to
      the gasserien ganglion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: pain alleviation
time frame: 1 month
description: pain assessment by functional MRI
arm group label: pulsed radiofrequency
arm group type: Active Comparator
description: sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then pulsed radiofrequency will be applied for 10 patients for 10 mins
arm group label: thermal Radiofrequency
arm group type: Active Comparator
description: sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then Thermal lesion will be applied for 10 patients for 2 cycles of 90 seconds
intervention type: Procedure
intervention name: pulsed Radiofrequency
description: sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then pulsed radiofrequency will be applied for 10 patients for 10 mins
arm group label: pulsed radiofrequency
intervention type: Procedure
intervention name: thermal Radiofrequency
description: sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then Thermal lesion will be applied for 10 patients for 2 cycles of 90 seconds
arm group label: thermal Radiofrequency
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: mohamed elsayed
investigator title: assisstant lecture
mesh term: Trigeminal Neuralgia
mesh term: Neuralgia
sharing ipd: Undecided