Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Validation of Neurokeeper's Algorithm on Patients Undergoing Cardiac Surgery.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Neurokeeper Technologies.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Neurokeeper Technologies
ClinicalTrials.gov Identifier:
NCT01737749
First received: November 27, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Stroke
Device: Neurokeeper stroke detector

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Neurokeeper Technologies:

Primary Outcome Measures:
  • Neurological detrioration detection [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Time from deterioration to detection [ Designated as safety issue: No ]
    The secondary objectives is correlations of EEG + ERP measurements with clinical evaluations as assessed by NIHSS


Groups/Cohorts Assigned Interventions
Patients undergoing cardiac surgery Device: Neurokeeper stroke detector
Electrophisoloigcal monitoring

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing cardiac surgery.

Criteria

Inclusion Criteria:

  • Age > 18 years old.
  • Patients undergoing cardiac surgery .

Exclusion Criteria:

  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737749

Contacts
Contact: Shay Bar Haim, Msc 972506822824 shaybarhaim@neurokeeper.com

Locations
Israel
Rambam Medical Center Not yet recruiting
Haifa, Israel
Contact: Moshe Herskovitz, MD    97248542605    m_herskovitz@rambam.health.gov.il   
Sponsors and Collaborators
Neurokeeper Technologies
Investigators
Principal Investigator: Moshe` Herskovitz, MD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Neurokeeper Technologies
ClinicalTrials.gov Identifier: NCT01737749     History of Changes
Other Study ID Numbers: NK-005
Study First Received: November 27, 2012
Last Updated: November 27, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Neurokeeper Technologies:
Stroke

ClinicalTrials.gov processed this record on November 24, 2014