An interventional study of Electroencephalography (EEG) in Stroke, Ischemic, sponsored by rambam62. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-12.
Sponsored by rambam62 · Not applicable, Interventional, and Diagnostic
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).
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 200 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with rambam62 as lead sponsor.
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Exclusion Criteria:
This open-label prospective study will be conducted in the single medical center (RAMBAM Medical Center) and will include at least 200 patients with acute ischemic stroke resulted from MCA or ICA occlusion.
Diagnostic Test: Electroencephalography (EEG)
Electroencephalography (EEG) is a painless and harmless method to record the bioelectric activity of the brain. Clinically, EEG refers to the recording of the brain's spontaneous electrical activity over a period of time, as recorded from multiple electrodes placed on the scalp This method can be helpful in the diagnosis of many various brain diseases and pathological conditions. For the examination, electrodes are placed on the head, using a special harmless gel, similar to gel, used in ultrasonographic studies.
EEG pattern
EEG patterns depending on size and location of acute ischemic stroke,including generalized or focal slowing or both and epileptiform discharges
Time frame: 24 months
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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