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Clinical Trials/NCT01737723
NCT01737723
Unknown
N/A

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

Neurokeeper Technologies1 site in 1 country20 target enrollmentAugust 2011
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Neurokeeper Technologies
Enrollment
20
Locations
1
Primary Endpoint
Detection of stroke
Last Updated
13 years ago

Overview

Brief Summary

The purpose of this study is Collecting data for an Electroencephalograph based algorithm for detection of onset and deterioration of Acute Ischemic Stroke by Comparison to NIHSS.

Detailed Description

Inclusion criteria study population Age \> 18 years old. Acute stroke symptoms onset within 120 hours of inclusion, and as proximate to event as possible. Acute ischemic moderate or severe hemispheric stroke (assessed as 5 points or more by NIHSS) and including patients treated by t-PA Exclusion criteria study population Primary intracranial hemorrhage on admission by CT. Significant movement disorder. Previous major hemispheric stroke. Local skull or skin affliction which prevents electrodes application. Any known condition which in the opinion of the investigator may interfere with the protocol implementation. Inclusion criteria Control Population Age \> 18 years old. Exclusion criteria Control Population Primary intracranial hemorrhage on admission by CT. Significant movement disorder. Previous major hemispheric stroke. Local skull or skin affliction which prevents electrodes application. Migraine Any known condition which in the opinion of the investigator may interfere with the protocol implementation.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
TBD
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Neurokeeper Technologies
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age \> 18 years old.
  • Acute stroke symptoms onset within 120 hours of inclusion, and as proximate to event as possible.
  • Acute ischemic moderate or severe hemispheric stroke (assessed as 5 points or more by NIHSS) and including patients treated by t-PA

Exclusion Criteria

  • Primary intracranial hemorrhage on admission by CT.
  • Significant movement disorder.
  • Previous major hemispheric stroke.
  • Local skull or skin affliction which prevents electrodes application.
  • Any known condition which in the opinion of the investigator may interfere with the protocol implementation

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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