Neurophysiological Examination in Patients With Brain Death

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

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.

Study Overview

• Status: Completed
• Conditions: Brain Death

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Turkey
  • Tusba / Zeve Kampus
    • Van, Tusba / Zeve Kampus, Turkey, 65080
      • Yuzuncu Yil University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in the adult intensive care unit

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axonal response	Measure of axonal response by electromyography	Within 72 hours from brain death diagnosis

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University
• Investigators: Study Director: Hilmi Demirkiran, MD, Department of Anethesiology and Reanimation; Principal Investigator: Aydin Cagac, MD, Department of Neurology

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2017
• Primary Completion (ACTUAL): May 15, 2018
• Study Completion (ACTUAL): September 15, 2019

Study Registration Dates

• First Submitted: August 19, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (ACTUAL): August 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Electromyography; Brain Death; Spinal Reflex
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Coma; Death; Brain Death
• Other Study ID Numbers: EMG in Brain Death

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No