Validation of an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS
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|ClinicalTrials.gov Identifier: NCT01738412|
Recruitment Status : Unknown
Verified November 2012 by Neurokeeper Technologies.
Recruitment status was: Not yet recruiting
First Posted : November 30, 2012
Last Update Posted : November 30, 2012
|Condition or disease||Intervention/treatment|
|Stroke||Device: Neurokeeper stroke detector|
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.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Validation of an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS.|
Device: Neurokeeper stroke detector
Monitoring stroke patients
- Detection of strokeEEG 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 strokeCorrelations between EEG + ERP changes and clinical status as assessed by NIHSS score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738412
|Contact: Shay Bar Haim, Mscemail@example.com|
|Hillel Yaffe Medical Center|
|Contact: Yaron River, MD 97249532747 YaronR@hy.health.gov.il|
|Principal Investigator: Yaron River, MD|