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CompletedNCT03262896Updated Oct 10, 2019

Neurophysiological Examination in Patients With Brain Death

An observational study in Brain Death, sponsored by Yuzuncu Yıl University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-10.

Sponsored by Yuzuncu Yıl University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years to 72 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Brain Death

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Keywords

  • Brain Death
  • Spinal Reflex
  • Electromyography
03

In context

Brain Death

74 studies on the registry are indexed under Brain Death; 10 are open to participants now.

This study's enrollment of 10 is below the median of 80 across 33 observational studies indexed under Brain Death.

Browse Brain Death studies →

Lead sponsor

Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.

Browse Yuzuncu Yıl University studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 72 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients in the adult intensive care unit

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. Axonal response

    Measure of axonal response by electromyography

    Time frame: Within 72 hours from brain death diagnosis

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Study locations

1 site
  • Yuzuncu Yil University, School of Medicine
    Van, Tusba / Zeve Kampus 65080, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2017 to primary completion in May 2018, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2017
First posted
Aug 25, 2017
StartActual
May 15, 2017
Primary completionActual
May 15, 2018
CompletionActual
Sep 15, 2019
Last update
Oct 10, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03262896
Lead sponsor
Yuzuncu Yıl University
Responsible party
Hilmi Demirkiran, MD (Assistant Professor, Yuzuncu Yıl University) — Principal investigator
First posted
Aug 25, 2017
Start date
May 15, 2017
Primary completion
May 15, 2018
Completion
Sep 15, 2019
Last update
Oct 10, 2019

Study contacts

Hilmi Demirkiran, MD
study director · Department of Anethesiology and Reanimation
Aydin Cagac, MD
principal investigator · Department of Neurology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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