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Not yet recruiting NCT03377062

CVA in Patients Suffering From Decreased Consciousness, Confusion or Headaches to an Emergency Room

Observational CVA

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EEG monitoring.
Who it may be relevant to
Registry conditions: CVA. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Cerebrovascular Accident (CVA) in Patients Suffering From Decreased Consciousness, Confusion or Headaches to an Emergency Room

Overview

A CVA occurs when there is a sudden interruption of blood supply to the brain. Fast identification of CVA is crucial in order to refer the patient to an appropriate medical center as well as to direct him/her to a suitable treatment upon arrival to the Medical Center, in order to minimize the permanent damage to the brain. In this study, we are evaluating a tool for detecting CVA based on EEG (electroencephalograph) data analysis using innovative algorithm. The system is comprised of four electrodes, reference electrode and earphones for auditory stimulation. In the study, 120 patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness will be monitored for five-minute each, with EEG accompanied with auditory stimulation. The EEG analysis will be performed based on the synchronization of the front and back hemispheres. During CVA, specific hemisphere is damaged, therefore desynchronization is expected. The purpose of this study is to develop a tool for identifying CVA in patients who have no clear CVA related signs.

Interventions

  • Diagnostic test EEG monitoring
    Five-minute of EEG monitoring accompanied with auditory stimulation.

Primary outcome measures

  • Desynchronization Index [Time frame: 1 day]
Secondary outcome measures (1)
  • EEG variablity [Time frame: 1 day]

Eligibility criteria

Inclusion criteria

Patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness

Exclusion criteria

Pregnant women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Israel · 1 center
  • Rambam Health Care Campus — Haifa

Identifiers

NCT: NCT03377062 · 260-16

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗