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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: CVA
• Intervention / Treatment: Diagnostic test: EEG monitoring

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Dana Baron Shahaf, MD PhD; Phone Number: +972-4-7772487; Email: dana_bs@rambam.health.gov.il

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant women

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EEG monitoring; Patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness	Diagnostic test: EEG monitoring; Five-minute of EEG monitoring accompanied with auditory stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desynchronization Index	Desynchronization Index calculated from EEG data correlation with CVA events	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG variablity	EEG variability will be evaluated in correlation to various medical measures (ECG, hypoglycemic state, hypothermia)	1 day

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Disease Attributes; Emergencies; Headache; Confusion
• Other Study ID Numbers: 260-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No