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

Study Overview
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Brief Summary
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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
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Inclusion criteria study population Age > 18 years old. 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. Patients with TIA lasting at least 5 minutes or minor acute ischemic stroke (NIHSS < 4 at the time of enrolment) 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 Intracranial hemorrhage on admission by CT. Previous major hemispheric stroke. Patients with pure sensory symptoms, Significant movement disorder. Local skull or skin affliction which prevents sensor application. Any known condition which in the opinion of the investigator may interfere with the protocol implementation.

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

Conditions
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Stroke

Intervention / Treatment
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* Device: Neurokeeper stroke detector


Participation Criteria
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Eligibility Criteria
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Inclusion criteria study population Age > 18 years old. 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. Patients with TIA lasting at least 5 minutes or minor acute ischemic stroke (NIHSS < 4 at the time of enrolment) 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 Intracranial hemorrhage on admission by CT. Previous major hemispheric stroke. Patients with pure sensory symptoms, Significant movement disorder. Local skull or skin affliction which prevents sensor application. Any known condition which in the opinion of the investigator may interfere with the protocol implementation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study population<br>Stroke patients | Device: Neurokeeper stroke detector<br>* Monitoring stroke patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation to severity of stroke | Correlations between EEG + ERP changes and clinical status as assessed by NIHSS score. |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke