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Electroencephalograph for Detection of Acute Ischemic Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Neurokeeper Technologies.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Neurokeeper Technologies
ClinicalTrials.gov Identifier:
NCT01737723
First received: November 27, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  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

Further study details as provided by Neurokeeper Technologies:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014