Validation of Neurokeeper's Algorithm on Patients Undergoing Carotid Endarterectomy

Stroke Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01737736
• Other study ID #: NK-004
• Status: Recruiting
• Phase: N/A
• First received: November 27, 2012
• Last updated: July 17, 2013
• Start date: June 2013

Study information

• Verified date: July 2013
• Source: Neurokeeper Technologies
• Contact: Shay Bar Haim, Msc
• Phone: 972506822824
• Email: shaybarhaim[@]neurokeeper.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Neurokeeper stroke detector
Electrophisoloigcal monitoring

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Neurokeeper Technologies

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No
Secondary	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		No