NCT01737736

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
Last Updated

July 18, 2013

Status Verified

July 1, 2013

First QC Date

November 27, 2012

Last Update Submit

July 17, 2013

Conditions

Stroke

Keywords

Stroke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Time from deterioration to detection

Study Arms (1)

Patients undergoing cartoid endarterectomy surgery

Device: Neurokeeper stroke detector

Interventions

Neurokeeper stroke detectorDEVICE

Electrophisoloigcal monitoring

Patients undergoing cartoid endarterectomy surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing Carotid Endarterectomy

You may qualify if:

  • Age \> 18 years old.
  • Primary Carotid Endarterectomy under local anesthesia in symptomatic or asymptomatic patients.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Moshe' Herskovitz, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shay Bar Haim, Msc

CONTACT

972506822824shaybarhaim@neurokeeper.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

November 29, 2012

Study Start

June 1, 2013

Last Updated

July 18, 2013

Record last verified: 2013-07

Locations

IL(1)