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Status unknownNCT01738412Updated Nov 30, 2012

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

An observational study in Stroke, sponsored by Neurokeeper Technologies. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-30.

Sponsored by Neurokeeper Technologies · Observational

The sponsor has not verified this record recently (last verified Nov 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Inclusion criteria study population

  1. Age > 18 years old.
  2. Acute stroke symptoms onset within 2 weeks of inclusion, and as proximate to event as possible and as long as there was no neurological deterioration (ΔNIHSS>4) from symptoms onset to inclusion.
  3. Patients with TIA lasting at least 5 minutes or minor acute ischemic stroke (NIHSS \< 4 at the time of enrolment)
  4. 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

Exclusion criteria study population

  1. Intracranial hemorrhage on admission by CT.
  2. Previous major hemispheric stroke.
  3. Patients with pure sensory symptoms,
  4. Significant movement disorder.
  5. Local skull or skin affliction which prevents sensor application.
  6. Any known condition which in the opinion of the investigator may interfere with the protocol implementation.
02

Conditions studied

  • Stroke

Keywords

  • Stroke
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 30 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Neurokeeper Technologies is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Stroke patients

Inclusion criteria

  1. Age > 18 years old.
  2. Acute stroke symptoms onset within 2 weeks of inclusion, and as proximate to event as possible and as long as there was no neurological deterioration (ΔNIHSS>4) from symptoms onset to inclusion.
  3. Patients with TIA lasting at least 5 minutes or minor acute ischemic stroke (NIHSS \< 4 at the time of enrolment)
  4. 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

Exclusion criteria

Exclusion criteria study population

  1. Intracranial hemorrhage on admission by CT.
  2. Previous major hemispheric stroke.
  3. Patients with pure sensory symptoms,
  4. Significant movement disorder.
  5. Local skull or skin affliction which prevents sensor application.
  6. Any known condition which in the opinion of the investigator may interfere with the protocol implementation.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Study population

    Stroke patients

    Device: Neurokeeper stroke detector

Interventions

  • DeviceNeurokeeper stroke detector

    Monitoring stroke patients

06

What researchers measure

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

    Correlations between EEG + ERP changes and clinical status as assessed by NIHSS score.

07

Study locations

1 site
  • Hillel Yaffe Medical Center
    Hadera, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01738412
Lead sponsor
Neurokeeper Technologies
Responsible party
Sponsor
First posted
Nov 30, 2012
Last update
Nov 30, 2012

Study contacts

Shay Bar Haim, Msc
Contact
shaybarhaim@neurokeeper.com
972506822824

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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