Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03377062
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Dana Baron Shahaf, MD PhD, 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.

Condition or disease Intervention/treatment
CVA Diagnostic Test: EEG monitoring

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebrovascular Accident (CVA) in Patients Suffering From Decreased Consciousness, Confusion or Headaches to an Emergency Room
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
EEG monitoring
Patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness
Diagnostic Test: EEG monitoring
Five-minute of EEG monitoring accompanied with auditory stimulation.




Primary Outcome Measures :
  1. Desynchronization Index [ Time Frame: 1 day ]
    Desynchronization Index calculated from EEG data correlation with CVA events


Secondary Outcome Measures :
  1. EEG variablity [ Time Frame: 1 day ]
    EEG variability will be evaluated in correlation to various medical measures (ECG, hypoglycemic state, hypothermia)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant women


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377062


Contacts
Layout table for location contacts
Contact: Dana Baron Shahaf, MD PhD +972-4-7772487 dana_bs@rambam.health.gov.il

Locations
Layout table for location information
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Layout table for additonal information
Responsible Party: Dana Baron Shahaf, MD PhD, Primary Investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03377062    
Other Study ID Numbers: 260-16
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Confusion
Emergencies
Headache
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Neurobehavioral Manifestations
Nervous System Diseases