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

NCT03377062 | Not Yet Recruiting

• 1 other identifier: 260-16
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

CVA

Outcome Measures

Primary Outcomes (1)

• Desynchronization Index

  Desynchronization Index calculated from EEG data correlation with CVA events

  1 day

Secondary Outcomes (1)

• EEG variablity

  1 day

Study Arms (1)

EEG monitoring

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

Diagnostic Test: EEG monitoring

Interventions

EEG monitoring DIAGNOSTIC_TEST

Five-minute of EEG monitoring accompanied with auditory stimulation.

EEG monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

Central Study Contacts

Dana Baron Shahaf, MD PhD

CONTACT

+972-4-7772487; dana_bs@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 19, 2017
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

IL (1)