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

Neurokeeper Technologies

Status: Unknown

Conditions: Stroke

Treatments: Device: Neurokeeper stroke detector

Study type: Observational

Funder types: Industry

Identifiers

NCT01737749

NK-005

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

Patients undergoing cardiac surgery

Treatment:

Device: Neurokeeper stroke detector