Validation of Neurokeeper's Algorithm on Patients Undergoing Carotid Endarterectomy

Neurokeeper Technologies

Status: Unknown

Conditions: Stroke

Treatments: Device: Neurokeeper stroke detector

Study type: Observational

Funder types: Industry

Identifiers

NCT01737736

NK-004

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

Patients undergoing cartoid endarterectomy surgery

Treatment:

Device: Neurokeeper stroke detector