- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01897194
Using EEG to Study Coma in the Neurocritical Care Unit
A Wireless EEG Patch Device for Continuous Electrographic Monitoring and Study of Coma in the Neurocritical Care Unit
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Coma Patients
Observation of EEG patterns in coma patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Emergence from coma
Time Frame: 1 year post admission
|
1 year post admission
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB_00059288
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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