Validation of Neurokeeper's Algorithm on Patients Undergoing Carotid Endarterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing cartoid endarterectomy surgery

Neurokeeper stroke detector

Intervention Type DEVICE

Electrophisoloigcal monitoring

Interventions

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Neurokeeper stroke detector

Electrophisoloigcal monitoring

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No