Validation of an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS

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

• Registration Number: NCT01738412
• Lead Sponsor: Neurokeeper Technologies

Brief Summary

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

Detailed Description

Inclusion criteria study population

1. Age \> 18 years old.

2. Acute stroke symptoms onset within 2 weeks of inclusion, and as proximate to event as possible and as long as there was no neurological deterioration (ΔNIHSS\>4) from symptoms onset to inclusion.

3. Patients with TIA lasting at least 5 minutes or minor acute ischemic stroke (NIHSS \< 4 at the time of enrolment)

4. More than 3 of the following:

Blood pressure \>140/90 or unknown, Irregular heartbeat, Atrial Fibrillation, Smoker, Cholesterol \>240 or unknown, Has Diabetes, Lack of physical exercise, Overweight, Has Stroke in the family

OR between 4 and 6 of the following:

Blood pressure 120-139/80-89, Unknown Irregular heartbeat, Atrial Fibrillation, Trying to quit smoking, Cholesterol 200-239, Borderline Diabetes, Some exercise, Slightly overweight, Not sure if Stroke occurred in family

Exclusion criteria study population

1. Intracranial hemorrhage on admission by CT.

2. Previous major hemispheric stroke.

3. Patients with pure sensory symptoms,

4. Significant movement disorder.

5. Local skull or skin affliction which prevents sensor application.

6. Any known condition which in the opinion of the investigator may interfere with the protocol implementation.

Study Timeline

• Status Verified: 2012-11
• Study First Submitted: 2012-11-28
• Study First Submitted QC: 2012-11-29
• Last Update Submitted: 2012-11-29
• Study First Posted: 2012-11-30
• Last Update Posted: 2012-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel