StrokeNCT01737749
Validation of Neurokeeper's Algorithm on Patients Undergoing Cardiac Surgery.
An observational study of Stroke, run by Neurokeeper Technologies at 1 site in Israel.
Trial summary
The primary objective of the study is to check the ability of Neurokeeper's algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Neurokeeper stroke detector
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
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 undergoing cardiac surgery.
Who may be able to join
- Age > 18 years old.
- Patients undergoing cardiac surgery .
Who cannot join
- Previous major hemispheric stroke.
- Any known major hemispheric lesion.
- Significant movement disorder.
- Local skull or skin affliction which prevents electrodes application.
- Any known condition which in the opinion of the investigator may interfere with the protocol implementation.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rambam Medical Center
Haifa
Moshe Herskovitz, MD, 97248542605, m_herskovitz@rambam.health.gov.il
About this study
The primary objective of the study is to check the ability of Neurokeeper's algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing cardiac surgery.
The secondary objectives is correlations of EEG + ERP measurements with clinical evaluations as assessed by NIHSS ThiS study is a prospective, open label, single arm, self control, single center study.
This study will be conducted in 50 subjects according to the inclusions/exclusions criteria.
- Conditions
- Stroke
- Being tested
- Neurokeeper stroke detector
- Keywords
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurokeeper stroke detectorDevice
Electrophisoloigcal monitoring
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing cardiac surgery | Not described Receives: Device: Neurokeeper stroke detector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological detrioration detection
The primary objective of the study is to validate an EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing cardiac surgery.
Secondary outcomes (1)
Time from deterioration to detection
The secondary objectives is correlations of EEG + ERP measurements with clinical evaluations as assessed by NIHSS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
Sponsor and investigators
- Lead sponsor
- Neurokeeper Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moshe' Herskovitz, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737749
- Sponsor's protocol ID
- NK-005
- Status last verified
- Nov 2012
- First submitted
- 27 Nov 2012
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Neurokeeper's Algorithm on Patients Undergoing Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT01737749
- Acronym / sponsor ID
- NK-005
- Conditions
- Stroke
- Keywords
- Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Neurokeeper TechnologiesIndustry (pharma, biotech, devices)
- First posted
- 29 Nov 2012 (estimated)
- 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.
The primary objective of the study is to check the ability of Neurokeeper's algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing cardiac surgery.
The secondary objectives is correlations of EEG + ERP measurements with clinical evaluations as assessed by NIHSS ThiS study is a prospective, open label, single arm, self control, single center study.
This study will be conducted in 50 subjects according to the inclusions/exclusions criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing cardiac surgery | – | Device: Neurokeeper stroke detector |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery.
Key inclusion criteria (2 listed)
- Age > 18 years old.
- Patients undergoing cardiac surgery .
Key exclusion criteria (5 listed)
- Previous major hemispheric stroke.
- Any known major hemispheric lesion.
- Significant movement disorder.
- Local skull or skin affliction which prevents electrodes application.
- Any known condition which in the opinion of the investigator may interfere with the protocol implementation.
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 |
|---|---|---|
| Neurokeeper stroke detectorElectrophisoloigcal monitoring | Device | Patients undergoing cardiac surgery |
Primary outcome
Neurological detrioration detection
The primary objective of the study is to validate an EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing cardiac surgery.
1 secondary outcome
Time from deterioration to detection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
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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. This study is not recruiting at the moment.
Moshe' Herskovitz, MD principal investigator
Rambam Health Care Campus
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 Stroke, run by Neurokeeper Technologies 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Nov 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shay Bar Haim, Msc (972506822824, shaybarhaim@neurokeeper.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological detrioration detection. 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 29 Nov 2012; AzTrials last refreshed its copy on 2 Nov 2026.