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

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ClinicalTrials.gov Identifier: NCT01738412
Recruitment Status : Unknown
Verified November 2012 by Neurokeeper Technologies.
Recruitment status was:  Not yet recruiting
First Posted : November 30, 2012
Last Update Posted : November 30, 2012
Sponsor:
Information provided by (Responsible Party):
Neurokeeper Technologies

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.

Condition or disease Intervention/treatment
Stroke Device: Neurokeeper stroke detector

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.

Study Type : Observational
Estimated Enrollment : 30 participants
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.

Group/Cohort Intervention/treatment
Study population
Stroke patients
Device: Neurokeeper stroke detector
Monitoring stroke patients



Primary Outcome Measures :
  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 Outcome Measures :
  1. Correlation to severity of stroke
    Correlations between EEG + ERP changes and clinical status as assessed by NIHSS score.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Neurokeeper Technologies
ClinicalTrials.gov Identifier: NCT01738412     History of Changes
Other Study ID Numbers: NK-002
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: November 30, 2012
Last Verified: November 2012

Keywords provided by Neurokeeper Technologies:
Stroke

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