Clinical trial NCT01738412: Validation of an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS
Official title: Validation of an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Stroke
Lead sponsor: Neurokeeper Technologies
Sponsor class: INDUSTRY
First posted: 2012-11-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients

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.

Eligibility 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.

Primary outcomes:
measure: Detection of stroke
Secondary outcomes:
measure: Correlation to severity of stroke
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References: