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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01738412
• Other study ID #: NK-002
• Status: Not yet recruiting
• Phase: N/A
• First received: November 28, 2012
• Last updated: November 29, 2012

Study information

• Verified date: November 2012
• Source: Neurokeeper Technologies
• Contact: Shay Bar Haim, Msc
• Phone: 972506822824
• Email: shaybarhaim[@]neurokeeper.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 (?NIHSS>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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Neurokeeper stroke detector
Monitoring stroke patients

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Neurokeeper Technologies

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No
Secondary	Correlation to severity of stroke	Correlations between EEG + ERP changes and clinical status as assessed by NIHSS score.		No