Neurophysiological Examination in Patients With Brain Death

Brain Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262896
• Other study ID #: EMG in Brain Death
• Status: Completed
• Start date: May 15, 2017
• Est. completion date: September 15, 2019

Study information

• Verified date: October 2019
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 15, 2019
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Brain Death
• Death

Locations

Country	Name	City	State
Turkey	Yuzuncu Yil University, School of Medicine	Van	Tusba / Zeve Kampus

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axonal response	Measure of axonal response by electromyography	Within 72 hours from brain death diagnosis