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

This study is not yet open for participant recruitment.
Verified November 2012 by Neurokeeper Technologies
Sponsor:
Information provided by (Responsible Party):
Neurokeeper Technologies
ClinicalTrials.gov Identifier:
NCT01738412
First received: November 28, 2012
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Stroke
Device: Neurokeeper stroke detector

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS.

Resource links provided by NLM:


Further study details as provided by Neurokeeper Technologies:

Primary Outcome Measures:
  • Detection of stroke [ Designated as safety issue: No ]
    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:
  • Correlation to severity of stroke [ Designated as safety issue: No ]
    Correlations between EEG + ERP changes and clinical status as assessed by NIHSS score.


Estimated Enrollment: 30
Groups/Cohorts Assigned Interventions
Study population
Stroke patients
Device: Neurokeeper stroke detector
Monitoring stroke patients

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Stroke patients

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738412

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

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel
Contact: Yaron River, MD    97249532747    YaronR@hy.health.gov.il   
Principal Investigator: Yaron River, MD         
Sponsors and Collaborators
Neurokeeper Technologies
  More Information

No publications provided

Responsible Party: Neurokeeper Technologies
ClinicalTrials.gov Identifier: NCT01738412     History of Changes
Other Study ID Numbers: NK-002
Study First Received: November 28, 2012
Last Updated: November 29, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Neurokeeper Technologies:
Stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 17, 2014