Validation of Neurokeeper's Algorithm on Patients Undergoing Carotid Endarterectomy

Neurokeeper Technologies

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Stroke

Interventions

Neurokeeper stroke detectorDEVICE

Electrophisoloigcal monitoring

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Rambam Medical Center

Haifa, Israel

RECRUITING

Outcomes

Primary Outcomes

Neurological detrioration detection

Secondary Outcomes

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

Central Contacts

Shay Bar Haim, Msc

CONTACT

972506822824 shaybarhaim@neurokeeper.com

Data from ClinicalTrials.gov

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