Validation of an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS
NCT ID: NCT01738412
Last Updated: 2012-11-30
Study Results
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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UNKNOWN
30 participants
OBSERVATIONAL
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Study population
Stroke patients
Neurokeeper stroke detector
Monitoring stroke patients
Interventions
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Neurokeeper stroke detector
Monitoring stroke patients
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Neurokeeper Technologies
INDUSTRY
Responsible Party
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Locations
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Hillel Yaffe Medical Center
Hadera, , Israel
Countries
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Central Contacts
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Facility Contacts
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Yaron River, MD
Role: primary
Other Identifiers
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NK-002
Identifier Type: -
Identifier Source: org_study_id