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NCT Number: NCT03377062

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.

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Key information

Conditions

CVA

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rambam Health Care Campus

Haifa, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Pregnant women

Treatment and study plan

EEG monitoring

Diagnostic Test

Five-minute of EEG monitoring accompanied with auditory stimulation.

Primary outcomes

  1. Desynchronization Index

    Time frame: 1 day

    Desynchronization Index calculated from EEG data correlation with CVA events

Secondary outcomes

  1. EEG variablity

    Time frame: 1 day

    EEG variability will be evaluated in correlation to various medical measures (ECG, hypoglycemic state, hypothermia)

Study contacts

Contact information is provided by the study sponsor or research team.

Dana Baron Shahaf, MD PhD

CONTACT

[email protected]

+972-4-7772487

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2017
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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