CVANCT03377062
CVA in Patients Suffering From Decreased Consciousness, Confusion or Headaches to an Emergency Room
An observational study of CVA, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CVA
- What is being tested?
- EEG monitoring
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness
Who may be able to join
- Patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cerebrovascular Accident (CVA) in Patients Suffering From Decreased Consciousness, Confusion or Headaches to an Emergency Room
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
- Being tested
- EEG monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG monitoringDiagnostic test
Five-minute of EEG monitoring accompanied with auditory stimulation.
| Study group | Role | What they receive |
|---|---|---|
| EEG monitoring | Patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness Receives: Diagnostic Test: EEG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desynchronization Index
Desynchronization Index calculated from EEG data correlation with CVA events
Measured: 1 day
Secondary outcomes (1)
EEG variablity
EEG variability will be evaluated in correlation to various medical measures (ECG, hypoglycemic state, hypothermia)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Jun 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CVAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dana Baron Shahaf, MD PhD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377062
- Sponsor's protocol ID
- 260-16
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2017
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrovascular Accident (CVA) in Patients Suffering From Decreased Consciousness, Confusion or Headaches to an Emergency Room
- ClinicalTrials.gov ID
- NCT03377062
- Acronym / sponsor ID
- 260-16
- Conditions
- CVA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EEG monitoring | – | Diagnostic Test: EEG monitoringPatients arriving to the emergency room with decreased consciousness, severe headaches or dizziness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness
Key inclusion criteria (1 listed)
- Patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness
Key exclusion criteria (1 listed)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG monitoringFive-minute of EEG monitoring accompanied with auditory stimulation. | Diagnostic test | EEG monitoring |
Primary outcome
Desynchronization Index
Time frame: 1 day
Desynchronization Index calculated from EEG data correlation with CVA events
1 secondary outcome
EEG variablity
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CVA, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dana Baron Shahaf, MD PhD (+972-4-7772487, dana_bs@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desynchronization Index (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.