<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/NCT04445766</url>
  </required_header>
  <id_info>
    <org_study_id>H-16019808</org_study_id>
    <nct_id>NCT04445766</nct_id>
  </id_info>
  <brief_title>Efficacy and Complications of Microvascular Decompression</brief_title>
  <official_title>Efficacy and Complications of Microvascular Decompression - a Prospective Systematic Study of 115 Trigeminal Neuralgia Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danish Headache Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Danish Headache Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a non-interventional prospective observational study in patients with trigeminal&#xD;
      neuralgia that undergoes micovascular decompression. The aim is to evaluate the efficacy and&#xD;
      complications 2 years after microvascular decompression&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to prospectively evaluate effect and complications 2 years after MVD&#xD;
      using independent assessors of outcome and complications.&#xD;
&#xD;
      Data of outcome and complications is collected prospectively based on based on standardized&#xD;
      follow-up schemes and questionnaires. Patients were assessed by independent assessors before&#xD;
      surgery and 3, 6, 12 and 24 months after surgery. Current pain level was evaluated according&#xD;
      to VAS and BNI pain scale. Complications were evaluated by the assessors by a questionnaire&#xD;
      and physical examination. All patients undergo a pre-surgical protocolized 3.0 Tesla MRI of&#xD;
      the brain and brainstem.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2012</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Degree of pain relief 2 years after MVD</measure>
    <time_frame>2 years</time_frame>
    <description>Barrow Neurological Institute pain intensity score (BNI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Degree of complication rate 2 years after MVD</measure>
    <time_frame>2 years</time_frame>
    <description>The frequency of predefined major and minor complications</description>
  </primary_outcome>
  <enrollment type="Actual">115</enrollment>
  <condition>Trigeminal Neuralgia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        We consecutively evaluated patients with the diagnosis of TN seen at the Danish Headache&#xD;
        Center (DHC), a tertiary medical referral centre for headache and facial pain. Patients who&#xD;
        were treated with MVD at the Department of Neurosurgery were included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older.&#xD;
&#xD;
          -  Most give Signed informed Consent.&#xD;
&#xD;
          -  Must fullfil the ICHD-3 beta diagnostic criteria for classical TN.Patients with purely&#xD;
             paroxysmal TN and patients with TN with concomitant persistent facial pain will be&#xD;
             included.&#xD;
&#xD;
          -  If the ICHD-3 beta diagnostic criteria is fulfilled and if complete clinical history,&#xD;
             neurological and physical examination and a 3.0 Tesla MRI do not raise any suspicion&#xD;
             of another causative disease such as painful posttraumatic trigeminal neuropathy or&#xD;
             symptomatic TN, subjects with sensory abnormalities detected at clinical neurological&#xD;
             examination are also included.&#xD;
&#xD;
          -  Has had a 3.0 Tesla MRI according to the trigeminal neuralgia protocol, prior to the&#xD;
             surgical intervention.&#xD;
&#xD;
          -  Semi-structured interview and neurological examination by the independent assessors&#xD;
             prior to neurosurgical intervention.&#xD;
&#xD;
          -  Has tried at least one, preferably two, sodium channel blocker (either carbamazepine&#xD;
             or oxcarbazepine) before referral to neurosurgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be excluded if one of the following exclusion criteria is met:&#xD;
&#xD;
          -  Psychiatric or mental illness or condition that might interfere with the ability of&#xD;
             the patients to fill in the Informed Consent and questionnaires.&#xD;
&#xD;
          -  Previous microvascular decompression as a treatment for trigeminal neuralgia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>March 23, 2022</last_update_submitted>
  <last_update_submitted_qc>March 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Danish Headache Center</investigator_affiliation>
    <investigator_full_name>Lars Bendtsen</investigator_full_name>
    <investigator_title>MD, PhD, Dr Med Sci</investigator_title>
  </responsible_party>
  <keyword>neurosurgery</keyword>
  <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>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/NCT04445766
org study id: H-16019808
nct id: NCT04445766
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study is a non-interventional prospective observational study in patients with trigeminal
      neuralgia that undergoes micovascular decompression. The aim is to evaluate the efficacy and
      complications 2 years after microvascular decompression
The aim of this study is to prospectively evaluate effect and complications 2 years after MVD
      using independent assessors of outcome and complications.

      Data of outcome and complications is collected prospectively based on based on standardized
      follow-up schemes and questionnaires. Patients were assessed by independent assessors before
      surgery and 3, 6, 12 and 24 months after surgery. Current pain level was evaluated according
      to VAS and BNI pain scale. Complications were evaluated by the assessors by a questionnaire
      and physical examination. All patients undergo a pre-surgical protocolized 3.0 Tesla MRI of
      the brain and brainstem.
observational model: Cohort
time perspective: Prospective
measure: Degree of pain relief 2 years after MVD
time frame: 2 years
description: Barrow Neurological Institute pain intensity score (BNI)
measure: Degree of complication rate 2 years after MVD
time frame: 2 years
description: The frequency of predefined major and minor complications
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Danish Headache Center
investigator full name: Lars Bendtsen
investigator title: MD, PhD, Dr Med Sci
mesh term: Trigeminal Neuralgia
mesh term: Neuralgia
sharing ipd: No