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Clinical Trials/NCT01738412
NCT01738412
Unknown
N/A

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

Neurokeeper Technologies1 site in 1 country30 target enrollmentNovember 30, 2012
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Neurokeeper Technologies
Enrollment
30
Locations
1
Primary Endpoint
Detection of stroke
Last Updated
13 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 30, 2012
End Date
TBD
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Neurokeeper Technologies
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Correlation to severity of stroke

Study Sites (1)

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