Electroencephalograph for Detection of Acute Ischemic Stroke

NCT ID: NCT01737723

Last Updated: 2012-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke

Keywords

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Stroke

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study population

Stroke patients

Neurokeeper stroke detector

Intervention Type DEVICE

Monitoring stroke patients

Interventions

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Neurokeeper stroke detector

Monitoring stroke patients

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Neurokeeper Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rambam Medical Center

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Shay Bar Haim, Msc

Role: CONTACT

Phone: 972506822824

Email: [email protected]

Facility Contacts

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Moshe Herskovitz, MD

Role: primary

Other Identifiers

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2011-NK-1

Identifier Type: -

Identifier Source: org_study_id