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Using EEG to Study Coma in the Neurocritical Care Unit

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01897194
First Posted: July 11, 2013
Last Update Posted: December 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert Hoesch, University of Utah
  Purpose
Despite its clinical significance, the pathophysiology of coma is still under investigation and the physiology of emergence from coma remains a mystery. Furthermore, predictors of emergence from coma, despite their obvious clinical value, remain un-established. Because of its low arousal state and hypothesized parallel neurophysiological mechanisms, sleep has been studied as both an animal and human model of coma, and awakening from sleep has likewise been studied as a surrogate of coma emergence. In this study, we will determine whether certain electrographic patterns, known as spectral shifts, which have correlates in normal sleep, are predictive of eventual awakening from coma and the time course of this emergence. To detect spectral shifts in comatose patients, EEG monitoring must be performed for several days. Quick, simple, and reliable EEG recording in the ICU will be enhanced by a small device that can be easily and properly positioned on the head by hospital personnel and which lacks cumbersome cables or receivers. Traditional EEG monitoring requires placement of up to 25 wires, which can impede efficient intensive patient care. Our hypothesis is that we can detect a difference in spectral shifts in comatose patients who will eventually emerge from coma as compared to comatose patients who do not wake up and that a wireless EEG patch-type device can effectively make this distinction.

Condition
Coma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Wireless EEG Patch Device for Continuous Electrographic Monitoring and Study of Coma in the Neurocritical Care Unit

Resource links provided by NLM:


Further study details as provided by Robert Hoesch, University of Utah:

Primary Outcome Measures:
  • Emergence from coma [ Time Frame: 1 year post admission ]

Enrollment: 1
Study Start Date: July 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Coma Patients
Observation of EEG patterns in coma patients.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Neuro Critical Care Patients
Criteria

Inclusion Criteria: All patients with brain injuries admitted to the neurocritical care unit will be screened for enrollment. The estimated enrollment will be for 100 patients. 90 patients will be comatose with Glascow Coma Scale < 9. The other 10 patients will be control, non-comatose patients for quality control of the device. Consent for inclusion will be obtained from the patient or next of kin for all enrolled patients.

Exclusion Criteria: None

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Robert Hoesch, Director, Neurocritical Care Division, University of Utah
ClinicalTrials.gov Identifier: NCT01897194     History of Changes
Other Study ID Numbers: IRB_00059288
First Submitted: July 8, 2013
First Posted: July 11, 2013
Last Update Posted: December 11, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms