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NCT03377062 Clinical Trial

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

CVA Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03377062
Other study ID # 260-16
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date December 2026

Study information
Verified date December 2023
Source Rambam Health Care Campus
Contact Dana Baron Shahaf, MD PhD
Phone +972-4-7772487
Email dana_bs@rambam.health.gov.il
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness Exclusion Criteria: Pregnant women

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Israel Rambam Health Care Campus Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Desynchronization Index Desynchronization Index calculated from EEG data correlation with CVA events 1 day
Secondary EEG variablity EEG variability will be evaluated in correlation to various medical measures (ECG, hypoglycemic state, hypothermia) 1 day
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