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Validation of Neurokeeper's Algorithm on Patients Undergoing Carotid Endarterectomy

This study is not yet open for participant recruitment.
Verified November 2012 by Neurokeeper Technologies
Sponsor:
Information provided by (Responsible Party):
Neurokeeper Technologies
ClinicalTrials.gov Identifier:
NCT01737736
First received: November 27, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Stroke
 Device: Neurokeeper stroke detector

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Neurokeeper Technologies:

Primary Outcome Measures:
  • Neurological detrioration detection [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Time from deterioration to detection [ Designated as safety issue: No ]
    The secondary objectives is measure time from ICA clamping to algorithm asymmetry detection, time from clinical deterioration to algorithm asymmetry detection


Groups/Cohorts Assigned Interventions
Patients undergoing cartoid endarterectomy surgery Device: Neurokeeper stroke detector
Electrophisoloigcal monitoring

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing Carotid Endarterectomy

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737736

Contacts
Contact: Shay Bar Haim, Msc 972506822824 shaybarhaim@neurokeeper.com

Locations
Israel
Rambam Medical Center Not yet recruiting
Haifa, Israel
Contact: Moshe Herskovitz, MD     97248542605     m_herskovitz@rambam.health.gov.il    
Sponsors and Collaborators
Neurokeeper Technologies
Investigators
Principal Investigator: Moshe` Herskovitz, MD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Neurokeeper Technologies
ClinicalTrials.gov Identifier: NCT01737736     History of Changes
Other Study ID Numbers: NK-004
Study First Received: November 27, 2012
Last Updated: November 27, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Neurokeeper Technologies:
Stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013