Validation of Neurokeeper's Algorithm on Patients Undergoing Cardiac Surgery.

NCT ID: NCT01737749

Last Updated: 2012-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Brief Summary

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The primary objective of the study is to check the ability of Neurokeeper's algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing cardiac surgery.

The secondary objectives is correlations of EEG + ERP measurements with clinical evaluations as assessed by NIHSS ThiS 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.

Detailed Description

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Conditions

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Stroke

Keywords

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing cardiac surgery

Neurokeeper stroke detector

Intervention Type DEVICE

Electrophisoloigcal monitoring

Interventions

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Neurokeeper stroke detector

Electrophisoloigcal monitoring

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years old.
* Patients undergoing cardiac surgery .

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neurokeeper Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moshe' Herskovitz, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

Central Contacts

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Shay Bar Haim, Msc

Role: CONTACT

Phone: 972506822824

Email: [email protected]

Facility Contacts

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Moshe Herskovitz, MD

Role: primary

Other Identifiers

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NK-005

Identifier Type: -

Identifier Source: org_study_id