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Validation of Neurokeeper's Algorithm on Patients Undergoing Carotid Endarterectomy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01737736
Enrollment
Unknown
Registered
2012-11-29
Start date
2013-06-30
Completion date
Unknown
Last updated
2013-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke

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.

Interventions

DEVICENeurokeeper stroke detector

Electrophisoloigcal monitoring

Sponsors

Neurokeeper Technologies
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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

Countries

Israel

Contacts

Primary ContactShay Bar Haim, Msc
shaybarhaim@neurokeeper.com972506822824

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026