Electroencephalograph for Detection of Acute Ischemic Stroke

• Conditions: Stroke
• Interventions: Device: Neurokeeper stroke detector

• Registration Number: NCT01737723
• Lead Sponsor: Neurokeeper Technologies

Brief Summary

The purpose of this study is Collecting data for an Electroencephalograph based algorithm for detection of onset and deterioration of Acute Ischemic Stroke by Comparison to NIHSS.

Detailed Description

Inclusion criteria study population Age \> 18 years old. Acute stroke symptoms onset within 120 hours of inclusion, and as proximate to event as possible.

Acute ischemic moderate or severe hemispheric stroke (assessed as 5 points or more by NIHSS) and including patients treated by t-PA

Exclusion criteria study population Primary intracranial hemorrhage on admission by CT. Significant movement disorder. Previous major hemispheric stroke. 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.

Inclusion criteria Control Population

Age \> 18 years old.

Exclusion criteria Control Population Primary intracranial hemorrhage on admission by CT. Significant movement disorder. Previous major hemispheric stroke. Local skull or skin affliction which prevents electrodes application. Migraine Any known condition which in the opinion of the investigator may interfere with the protocol implementation.

Study Timeline

• Study Start: 2011-08
• Status Verified: 2012-11
• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-27
• Last Update Submitted: 2012-11-27
• Study First Posted: 2012-11-29
• Last Update Posted: 2012-11-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age > 18 years old.
• Acute stroke symptoms onset within 120 hours of inclusion, and as proximate to event as possible.
• Acute ischemic moderate or severe hemispheric stroke (assessed as 5 points or more by NIHSS) and including patients treated by t-PA

Exclusion Criteria

• Primary intracranial hemorrhage on admission by CT.
• Significant movement disorder.
• Previous major hemispheric stroke.
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study population	Neurokeeper stroke detector	Stroke patients

Primary Outcome Measures

Name	Time	Method
Detection of stroke		EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation as assessed by NIHSS score.

Secondary Outcome Measures

Name	Time	Method
Correlation to severity of stroke		Correlations between EEG + ERP changes and clinical status as assessed by NIHSS score.

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel