Electroencephalograph for Detection of Acute Ischemic Stroke
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Purpose
The purpose of this study is Collecting data for an Electroencephalograph based algorithm for detection of onset and deterioration of Acute Ischemic Stroke by Comparison to NIHSS.
| Condition | Intervention |
|---|---|
|
Stroke |
Device: Neurokeeper stroke detector |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Collecting Data for 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.
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2011 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Study population
Stroke patients
|
Device: Neurokeeper stroke detector
Monitoring stroke patients
|
Detailed Description:
Inclusion criteria study population Age > 18 years old. Acute stroke symptoms onset within 120 hours of inclusion, and as proximate to event as possible.
Acute ischemic moderate or severe hemispheric stroke (assessed as 5 points or more by NIHSS) and including patients treated by t-PA
Exclusion criteria study population Primary intracranial hemorrhage on admission by CT. Significant movement disorder. Previous major hemispheric stroke. Local skull or skin affliction which prevents electrodes application. Any known condition which in the opinion of the investigator may interfere with the protocol implementation.
Inclusion criteria Control Population
Age > 18 years old.
Exclusion criteria Control Population Primary intracranial hemorrhage on admission by CT. Significant movement disorder. Previous major hemispheric stroke. Local skull or skin affliction which prevents electrodes application. Migraine Any known condition which in the opinion of the investigator may interfere with the protocol implementation.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Stroke patients
Inclusion Criteria:
- Age > 18 years old.
- Acute stroke symptoms onset within 120 hours of inclusion, and as proximate to event as possible.
- Acute ischemic moderate or severe hemispheric stroke (assessed as 5 points or more by NIHSS) and including patients treated by t-PA
Exclusion Criteria:
- Primary intracranial hemorrhage on admission by CT.
- Significant movement disorder.
- Previous major hemispheric stroke.
- Local skull or skin affliction which prevents electrodes application.
- Any known condition which in the opinion of the investigator may interfere with the protocol implementation
Contacts and Locations| Contact: Shay Bar Haim, Msc | 972506822824 | shaybarhaim@neurokeeper.com |
| Israel | |
| Rambam Medical Center | Recruiting |
| Haifa, Israel | |
| Contact: Moshe Herskovitz, MD 97248542605 m_herskovitz@rambam.health.gov.il | |
| Principal Investigator: Gregory Telman, MD | |
More Information
No publications provided
| Responsible Party: | Neurokeeper Technologies |
| ClinicalTrials.gov Identifier: | NCT01737723 History of Changes |
| Other Study ID Numbers: | 2011-NK-1 |
| Study First Received: | November 27, 2012 |
| Last Updated: | November 27, 2012 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Neurokeeper Technologies:
|
Stroke |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 21, 2013