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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01738412
Enrollment
30
Registered
2012-11-30
Start date
Unknown
Completion date
Unknown
Last updated
2012-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke

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.

Interventions

Monitoring stroke patients

Sponsors

Neurokeeper Technologies
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Detection of strokeEEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation as assessed by NIHSS score.

Secondary

MeasureTime frameDescription
Correlation to severity of strokeCorrelations between EEG + ERP changes and clinical status as assessed by NIHSS score.

Countries

Israel

Contacts

Primary ContactShay Bar Haim, Msc
shaybarhaim@neurokeeper.com972506822824

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026