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Completed

NCT Number: NCT03262896

Neurophysiological Examination in Patients With Brain Death

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.

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Key information

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yuzuncu Yil University, School of Medicine

Van, Tusba / Zeve Kampus, 65080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

  1. Axonal response

    Time frame: Within 72 hours from brain death diagnosis

    Measure of axonal response by electromyography

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

Neurophysiological Study in Patients With Brain Death: A Single Center Prospective Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 25, 2017
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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