<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/NCT03262896</url>
  </required_header>
  <id_info>
    <org_study_id>EMG in Brain Death</org_study_id>
    <nct_id>NCT03262896</nct_id>
  </id_info>
  <brief_title>Neurophysiological Examination in Patients With Brain Death</brief_title>
  <official_title>Neurophysiological Study in Patients With Brain Death: A Single Center Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuzuncu Yıl University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuzuncu Yıl University</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>
      This study examines muscle movements of elecromyography in adults with brain death. Half of&#xD;
      the participants will have brain death, the other half will be healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In some of the patients who have brain death diagnosis, some movements may be seen. Because&#xD;
      of these movements, the doctors sometimes avoid to make brain death diagnosis. So making&#xD;
      brain death diagnosis may delay. And in these patients, even if the brain death diagnosis&#xD;
      made the family members refuse to donate the organs of the patients because they think their&#xD;
      patients may survive when they see muscle movements with touch. These patients with brain&#xD;
      death are lost in a short time, so some of the patients can not be used as donors. In this&#xD;
      study, the investigators aim to raise awareness the movements in brain death patients can be&#xD;
      seen, to study the movements neurophysiologically by EMG, whether EMG can be used as&#xD;
      auxiliary method or not in brain death diagnosis and to raise organ donation numbers from&#xD;
      cadavers. Investigators will examine the motor response and F response in the facial nerve,&#xD;
      median nerve, and tibialis posterior nerve with electromyography neurophysiologically.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Actual">September 15, 2019</completion_date>
  <primary_completion_date type="Actual">May 15, 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Axonal response</measure>
    <time_frame>Within 72 hours from brain death diagnosis</time_frame>
    <description>Measure of axonal response by electromyography</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Brain Death</condition>
  <arm_group>
    <arm_group_label>Patients with brain death</arm_group_label>
    <description>Ten patients with definite etiology, who were diagnosed with brain death because of Apnea test positive and / or cranial reflexes were not available and were male and female patients aged 18-72 years</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients in the adult intensive care unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with definite diagnosis of brain death,&#xD;
&#xD;
          -  Patients with permission from their parents,&#xD;
&#xD;
          -  Patients without trauma of medullaspinalis and peripheral nerve injuries,&#xD;
&#xD;
          -  Patients without previously known muscle disease (Myasthenia gravis, myopathy, etc.),&#xD;
&#xD;
          -  Patients with previously unknown neurological disease (Amyotrophic Lateral Sclerosis,&#xD;
             Multiple sclerosis, Guillain Barre syndrome, Poliomyelitis, etc.),&#xD;
&#xD;
          -  Patients who have not previous systemic diseases (Connective Tissue Disease, Diabetes&#xD;
             mellitus, Chronic renal failure, etc.).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncertain brain death,&#xD;
&#xD;
          -  Patients without permission of family members,&#xD;
&#xD;
          -  Younger than 18 years old and older than 72 years,&#xD;
&#xD;
          -  Patients with medulla spinalis and peripheral nerve injuries,&#xD;
&#xD;
          -  Patients with known muscle disease (Myasthenia gravis, myopathy, etc.),&#xD;
&#xD;
          -  Patients with neurological disease (Amyotrophic Lateral Sclerosis, Multiple Sclerosis,&#xD;
             Guillain Barre Syndrome, Poliomyelitis, etc.),&#xD;
&#xD;
          -  Patients with previous systemic diseases (Connective Tissue Disease, Diabetes, Chronic&#xD;
             Kidney Failure, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>72 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hilmi Demirkiran, MD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Anethesiology and Reanimation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aydin Cagac, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neurology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yuzuncu Yil University, School of Medicine</name>
      <address>
        <city>Van</city>
        <state>Tusba / Zeve Kampus</state>
        <zip>65080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>October 8, 2019</last_update_submitted>
  <last_update_submitted_qc>October 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yuzuncu Yıl University</investigator_affiliation>
    <investigator_full_name>Hilmi Demirkiran, MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Brain Death</keyword>
  <keyword>Spinal Reflex</keyword>
  <keyword>Electromyography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Death</mesh_term>
    <mesh_term>Death</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/NCT03262896
org study id: EMG in Brain Death
nct id: NCT03262896
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study examines muscle movements of elecromyography in adults with brain death. Half of
      the participants will have brain death, the other half will be healthy volunteers.
In some of the patients who have brain death diagnosis, some movements may be seen. Because
      of these movements, the doctors sometimes avoid to make brain death diagnosis. So making
      brain death diagnosis may delay. And in these patients, even if the brain death diagnosis
      made the family members refuse to donate the organs of the patients because they think their
      patients may survive when they see muscle movements with touch. These patients with brain
      death are lost in a short time, so some of the patients can not be used as donors. In this
      study, the investigators aim to raise awareness the movements in brain death patients can be
      seen, to study the movements neurophysiologically by EMG, whether EMG can be used as
      auxiliary method or not in brain death diagnosis and to raise organ donation numbers from
      cadavers. Investigators will examine the motor response and F response in the facial nerve,
      median nerve, and tibialis posterior nerve with electromyography neurophysiologically.
observational model: Cohort
time perspective: Prospective
measure: Axonal response
time frame: Within 72 hours from brain death diagnosis
description: Measure of axonal response by electromyography
arm group label: Patients with brain death
description: Ten patients with definite etiology, who were diagnosed with brain death because of Apnea test positive and / or cranial reflexes were not available and were male and female patients aged 18-72 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 72 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hilmi Demirkiran, MD
role: Study Director
affiliation: Department of Anethesiology and Reanimation
last name: Aydin Cagac, MD
role: Principal Investigator
affiliation: Department of Neurology
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Yuzuncu Yıl University
investigator full name: Hilmi Demirkiran, MD
investigator title: Assistant Professor
mesh term: Brain Death
mesh term: Death
sharing ipd: Undecided