NCT01738412

Brief Summary

The purpose of this study is the validation of 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
30

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

First Submitted

Initial submission to the registry

November 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
Last Updated

November 30, 2012

Status Verified

November 1, 2012

First QC Date

November 28, 2012

Last Update Submit

November 29, 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 VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke patients

You may qualify if:

  • Age \> 18 years old.
  • Patients with TIA lasting at least 5 minutes or minor acute ischemic stroke (NIHSS \< 4 at the time of enrolment)
  • More than 3 of the following:
  • Blood pressure \>140/90 or unknown, Irregular heartbeat, Atrial Fibrillation, Smoker, Cholesterol \>240 or unknown, Has Diabetes, Lack of physical exercise, Overweight, Has Stroke in the family
  • OR between 4 and 6 of the following:
  • Blood pressure 120-139/80-89, Unknown Irregular heartbeat, Atrial Fibrillation, Trying to quit smoking, Cholesterol 200-239, Borderline Diabetes, Some exercise, Slightly overweight, Not sure if Stroke occurred in family

You may not qualify if:

  • Intracranial hemorrhage on admission by CT.
  • Previous major hemispheric stroke.
  • Patients with pure sensory symptoms,
  • Significant movement disorder.
  • Local skull or skin affliction which prevents sensor 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)

Hillel Yaffe Medical Center

Hadera, Israel

Location

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 ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2012

First Posted

November 30, 2012

Last Updated

November 30, 2012

Record last verified: 2012-11

Locations

IL(1)