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

• Sponsor: Rambam Health Care Campus (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT03377062
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 5

Study Details

Study Description

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	Phase
CVA	Diagnostic Test: EEG monitoring

Study Design

• Study Type: Observational
• Anticipated 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
• Anticipated Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Feb 1, 2024

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Desynchronization Index [1 day]

   Desynchronization Index calculated from EEG data correlation with CVA events

Secondary Outcome Measures

1. EEG variablity [1 day]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam Health Care Campus	Haifa		Israel

Sponsors and Collaborators

• Rambam Health Care Campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Dec 19, 2017
• Last Update Posted: Dec 27, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Confusion; Emergencies; Headache

Study Results

No Results Posted as of Dec 27, 2021