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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01737749
Enrollment
Unknown
Registered
2012-11-29
Start date
Unknown
Completion date
Unknown
Last updated
2012-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke

Brief summary

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.

Interventions

Electrophisoloigcal monitoring

Sponsors

Neurokeeper Technologies
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Neurological detrioration detectionThe 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 cardiac surgery.

Secondary

MeasureTime frameDescription
Time from deterioration to detectionThe secondary objectives is correlations of EEG + ERP measurements with clinical evaluations as assessed by NIHSS

Countries

Israel

Contacts

Primary ContactShay Bar Haim, Msc
shaybarhaim@neurokeeper.com972506822824

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026