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

• Conditions: Stroke

• Registration Number: NCT01737749
• Lead Sponsor: Neurokeeper Technologies

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-11
• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-27
• Last Update Submitted: 2012-11-27
• Study First Posted: 2012-11-29
• Last Update Posted: 2012-11-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time from deterioration to detection		The secondary objectives is correlations of EEG + ERP measurements with clinical evaluations as assessed by NIHSS

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel