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Electroencephalograph for Detection of Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT01737723
Recruitment Status : Unknown
Verified November 2012 by Neurokeeper Technologies.
Recruitment status was:  Recruiting
First Posted : November 29, 2012
Last Update Posted : November 29, 2012
Sponsor:
Information provided by (Responsible Party):
Neurokeeper Technologies

Brief Summary:
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 or disease Intervention/treatment
Stroke Device: Neurokeeper stroke detector

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.


Study Type : Observational
Estimated Enrollment : 20 participants
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
Study Start Date : August 2011

Group/Cohort Intervention/treatment
Study population
Stroke patients
Device: Neurokeeper stroke detector
Monitoring stroke patients



Primary Outcome Measures :
  1. 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 :
  1. Correlation to severity of stroke
    Correlations between EEG + ERP changes and clinical status as assessed by NIHSS score.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Stroke patients
Criteria

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

Information from the National Library of Medicine

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): NCT01737723


Contacts
Contact: Shay Bar Haim, Msc 972506822824 shaybarhaim@neurokeeper.com

Locations
Israel
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Moshe Herskovitz, MD    97248542605    m_herskovitz@rambam.health.gov.il   
Principal Investigator: Gregory Telman, MD         
Sponsors and Collaborators
Neurokeeper Technologies

Responsible Party: Neurokeeper Technologies
ClinicalTrials.gov Identifier: NCT01737723     History of Changes
Other Study ID Numbers: 2011-NK-1
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: November 29, 2012
Last Verified: November 2012

Keywords provided by Neurokeeper Technologies:
Stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases