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

Neurokeeper Technologies

Status: Unknown

Conditions: Stroke

Treatments: Device: Neurokeeper stroke detector

Study type: Observational

Funder types: Industry

Identifiers

NCT01738412

NK-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

30 participants in 1 patient group

Study population

Description:

Stroke patients

Treatment:

Device: Neurokeeper stroke detector