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

NCT ID: NCT03377062

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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CVA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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EEG monitoring

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

EEG monitoring

Intervention Type DIAGNOSTIC_TEST

Five-minute of EEG monitoring accompanied with auditory stimulation.

Interventions

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EEG monitoring

Five-minute of EEG monitoring accompanied with auditory stimulation.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Dana Baron Shahaf, MD PhD

Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rambam Health Care Campus

Haifa, , Israel

Site Status

Countries

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Israel

Central Contacts

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Dana Baron Shahaf, MD PhD

Role: CONTACT

Phone: +972-4-7772487

Email: [email protected]

Other Identifiers

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260-16

Identifier Type: -

Identifier Source: org_study_id