Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-29 @ 9:55 AM
Study NCT ID:
NCT04412434
Status:
UNKNOWN
Last Update Posted:
2021-03-12
First Post:
2020-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EEG Patterns in Patients With Acute Ischemic Stroke Resulted From Large Vessels Occlusion in the Anterior Circulation
Sponsor:
rambam62
Organization:
Study Overview
Official Title:
EEG Patterns in Patients With Acute Ischemic Stroke Resulted From Large Vessels Occlusion in the Anterior Circulation
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Clinical deterioration is observing in up to forty percent of patients with acute ischemic stroke (AIS) due to large vessels occlusion. Until now, there is no automated monitoring system for early detection of neurological deterioration in such patients. As a first step to develop such system investigators suggest this study aiming to evaluate patterns of brain electrical activity registered by EEG in patients with AIS attributed to the MCA or ICA territory correlated with location and extension of ischemic lesions as determined by non-contrast CT (NCT).
Detailed Description:
Rationale. Despite the exciting developments in the treatment of acute ischemic stroke (AIS) in last years, the problem of neurological deterioration in patients with AIS remains unresolved and poorly understandable. This is especially correct about patients with AIS resulted from large vessel occlusion (LVO), mainly internal carotid artery (ICA) and middle cerebral artery (MCA) occlusion. Such deterioration is observing in up to forty percent of patients with acute ischemic stroke due to LVO. On the other side, according to the literature about 40 % of LVO strokes resulted from atrial fibrillation. Until now, there is no automated monitoring system for early detection of neurological deterioration in AIS patients. Such monitoring system may save millions of lives of stroke victims all over the world. As a first step to develop such system based on change of brain electrical activity registered by electroencephalography (EEG) in patients with AIS investigators suggest this study.
Overall goal. The aim of the suggested research is to evaluate patterns of brain electrical activity registered by EEG in patients with AIS attributed to the MCA or ICA territory in correlation with location and extension of ischemic lesions as determined by non-contrast CT (NCT). Based on these data, the attempt to find algorithms, describing such correlation will be done.
Target population. The prospective study will include at least 200 AIS patients with acute stroke resulted from MCA or ICA occlusion.
Methods. Non contrast CT and EEG will be done at the same day. Neurologist will evaluate neurological status at the day of EEG and CT performing and clinical score by National Institute of Health Stroke Scale (NIHSS) will be obtained. EEG will be performed continuously for at least 30 minutes with 19-channel EEG machine.
Assessment. After gathering clinical, EEG and NCT data mathematical and computerized analysis (including Artificial Intelligence methods) will be applied aiming to find algorithms describing relationship between size and location of AIS and change in brain electrical activity registered by EEG in AIS patients.
Overall goal. The aim of the suggested research is to evaluate patterns of brain electrical activity registered by EEG in patients with AIS attributed to the MCA or ICA territory in correlation with location and extension of ischemic lesions as determined by non-contrast CT (NCT). Based on these data, the attempt to find algorithms, describing such correlation will be done.
Target population. The prospective study will include at least 200 AIS patients with acute stroke resulted from MCA or ICA occlusion.
Methods. Non contrast CT and EEG will be done at the same day. Neurologist will evaluate neurological status at the day of EEG and CT performing and clinical score by National Institute of Health Stroke Scale (NIHSS) will be obtained. EEG will be performed continuously for at least 30 minutes with 19-channel EEG machine.
Assessment. After gathering clinical, EEG and NCT data mathematical and computerized analysis (including Artificial Intelligence methods) will be applied aiming to find algorithms describing relationship between size and location of AIS and change in brain electrical activity registered by EEG in AIS patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: