Electroencephalograph for Detection of Acute Ischemic Stroke

November 27, 2012 updated by: Neurokeeper Technologies

Collecting Data for an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Recruiting
        • Rambam Medical Center
        • Contact:
        • Principal Investigator:
          • Gregory Telman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Stroke patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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

Outcome Measure
Measure Description
Correlation to severity of stroke
Correlations between EEG + ERP changes and clinical status as assessed by NIHSS score.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurokeeper Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Study Registration Dates

First Submitted

November 27, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (Estimate)

November 29, 2012

Study Record Updates

Last Update Posted (Estimate)

November 29, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-NK-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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