Validation of an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|