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

Not yet recruiting

• Conditions: CVA
• Interventions: Diagnostic Test: EEG monitoring

• Registration Number: NCT03377062
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-13
• Study First Posted: 2017-12-19
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08
• Study Start: 2024-06-01
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EEG monitoring	EEG monitoring	Patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness

Primary Outcome Measures

Name	Time	Method
Desynchronization Index	1 day	Desynchronization Index calculated from EEG data correlation with CVA events

Secondary Outcome Measures

Name	Time	Method
EEG variablity	1 day	EEG variability will be evaluated in correlation to various medical measures (ECG, hypoglycemic state, hypothermia)

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel