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

Stroke Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01737749
• Other study ID #: NK-005
• Status: Not yet recruiting
• Phase: N/A
• First received: November 27, 2012
• Last updated: November 27, 2012

Study information

• Verified date: November 2012
• Source: Neurokeeper Technologies
• Contact: Shay Bar Haim, Msc
• Phone: 972506822824
• Email: shaybarhaim[@]neurokeeper.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Neurokeeper stroke detector
Electrophisoloigcal monitoring

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Neurokeeper Technologies

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No
Secondary	Time from deterioration to detection	The secondary objectives is correlations of EEG + ERP measurements with clinical evaluations as assessed by NIHSS		No