Validation of Neurokeeper's Algorithm on Patients Undergoing Carotid Endarterectomy

• Conditions: Stroke
• Interventions: Device: Neurokeeper stroke detector

• Registration Number: NCT01737736
• Lead Sponsor: Neurokeeper Technologies

Brief Summary

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 Carotid Endarterectomy.

The secondary objectives is measure time from ICA clamping to algorithm asymmetry detection, time from clinical deterioration to algorithm asymmetry detection Thi 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

• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-29
• Study Start: 2013-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-17
• Last Update Posted: 2013-07-18

Recruitment & Eligibility

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

Inclusion Criteria

• Age > 18 years old.
• Primary Carotid Endarterectomy under local anesthesia in symptomatic or asymptomatic patients.

Exclusion Criteria

• General anesthesia
• Selective carotid artery shunting.
• 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

Arm && Interventions

Group	Intervention	Description
Patients undergoing cartoid endarterectomy surgery	Neurokeeper stroke detector	-

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 Carotid Endarterectomy.

Secondary Outcome Measures

Name	Time	Method
Time from deterioration to detection		The secondary objectives is measure time from ICA clamping to algorithm asymmetry detection, time from clinical deterioration to algorithm asymmetry detection

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel