Validation of an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Validation of an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS.|
- Detection of stroke [ Designated as safety issue: No ]EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation as assessed by NIHSS score.
- Correlation to severity of stroke [ Designated as safety issue: No ]Correlations between EEG + ERP changes and clinical status as assessed by NIHSS score.
Device: Neurokeeper stroke detector
Monitoring stroke patients
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738412
|Contact: Shay Bar Haim, Mscfirstname.lastname@example.org|
|Hillel Yaffe Medical Center||Not yet recruiting|
|Contact: Yaron River, MD 97249532747 YaronR@hy.health.gov.il|
|Principal Investigator: Yaron River, MD|