Neurophysiological Examination in Patients With Brain Death

Sponsor
Yuzuncu Yıl University (Other)
Overall Status
Completed
CT.gov ID
NCT03262896
Collaborator
(none)
10
1
28
0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Neurophysiological Study in Patients With Brain Death: A Single Center Prospective Study
    Actual Study Start Date :
    May 15, 2017
    Actual Primary Completion Date :
    May 15, 2018
    Actual Study Completion Date :
    Sep 15, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with brain death

    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

    Outcome Measures

    Primary Outcome Measures

    1. Axonal response [Within 72 hours from brain death diagnosis]

      Measure of axonal response by electromyography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 72 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Adult patients with definite diagnosis of brain death,

    • Patients with permission from their parents,

    • Patients without trauma of medullaspinalis and peripheral nerve injuries,

    • Patients without previously known muscle disease (Myasthenia gravis, myopathy, etc.),

    • Patients with previously unknown neurological disease (Amyotrophic Lateral Sclerosis, Multiple sclerosis, Guillain Barre syndrome, Poliomyelitis, etc.),

    • Patients who have not previous systemic diseases (Connective Tissue Disease, Diabetes mellitus, Chronic renal failure, etc.).

    Exclusion Criteria:
    • Uncertain brain death,

    • Patients without permission of family members,

    • Younger than 18 years old and older than 72 years,

    • Patients with medulla spinalis and peripheral nerve injuries,

    • Patients with known muscle disease (Myasthenia gravis, myopathy, etc.),

    • Patients with neurological disease (Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Guillain Barre Syndrome, Poliomyelitis, etc.),

    • Patients with previous systemic diseases (Connective Tissue Disease, Diabetes, Chronic Kidney Failure, etc.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yuzuncu Yil University, School of Medicine Van Tusba / Zeve Kampus Turkey 65080

    Sponsors and Collaborators

    • Yuzuncu Yıl University

    Investigators

    • Study Director: Hilmi Demirkiran, MD, Department of Anethesiology and Reanimation
    • Principal Investigator: Aydin Cagac, MD, Department of Neurology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hilmi Demirkiran, MD, Assistant Professor, Yuzuncu Yıl University
    ClinicalTrials.gov Identifier:
    NCT03262896
    Other Study ID Numbers:
    • EMG in Brain Death
    First Posted:
    Aug 25, 2017
    Last Update Posted:
    Oct 10, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hilmi Demirkiran, MD, Assistant Professor, Yuzuncu Yıl University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 10, 2019