Electroencephalograph for Detection of Acute Ischemic Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01737723
• Other study ID #: 2011-NK-1
• Status: Recruiting
• Phase: N/A
• First received: November 27, 2012
• Last updated: November 27, 2012
• Start date: August 2011

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Neurokeeper stroke detector
Monitoring stroke patients

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

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