Using EEG to Study Coma in the Neurocritical Care Unit

NCT ID: NCT01897194

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-07-31

Brief Summary

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.

Conditions

Coma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Coma Patients

Observation of EEG patterns in coma patients.

No interventions assigned to this group

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IRB_00059288

Identifier Type: -

Identifier Source: org_study_id