NCT01737723

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
Last Updated

November 29, 2012

Status Verified

November 1, 2012

First QC Date

November 27, 2012

Last Update Submit

November 27, 2012

Conditions

Stroke

Keywords

Stroke

Outcome Measures

Primary Outcomes (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 Outcomes (1)

  • Correlation to severity of stroke

Study Arms (1)

Study population

Stroke patients

Device: Neurokeeper stroke detector

Interventions

Neurokeeper stroke detectorDEVICE

Monitoring stroke patients

Study population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke patients

You may qualify if:

  • Age \> 18 years old.
  • Acute ischemic moderate or severe hemispheric stroke (assessed as 5 points or more by NIHSS) and including patients treated by t-PA

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Shay Bar Haim, Msc

CONTACT

972506822824shaybarhaim@neurokeeper.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

November 29, 2012

Study Start

August 1, 2011

Last Updated

November 29, 2012

Record last verified: 2012-11

Locations

IL(1)