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EEG Patterns in Patients With Acute Ischemic Stroke Resulted From Large Vessels Occlusion in the Anterior Circulation

Primary Purpose

Stroke, Ischemic

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Electroencephalography (EEG)
Sponsored by
rambam62
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke, Ischemic focused on measuring eeg pattern, acute ischemic stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with acute ischemic stroke, due to large vessel occlusion
  • Age of 18 years and more
  • Male or Female
  • Modified Rankin Scale of ≤ 2 prior to presentation
  • NIHSS ≥ 4 at the day of NCT and EEG

Exclusion Criteria:

  • Epilepsy
  • Brainstem or cerebellar stroke
  • Intracranial or extracranial hemorrhage of any kind
  • History of severe head trauma
  • History of severe dementia or progressive neurodegenerative disease
  • Cerebral tumor or hydrocephalus by anamnesis or by imaging
  • Lacunar stroke
  • Significant movement disorder.
  • Local skull or skin condition, preventing EEG electrode application.
  • Any known disorder, which may interfere with the protocol implementation.

Sites / Locations

  • Rambam MCRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patients with acute ischemic stroke

Arm Description

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.

Outcomes

Primary Outcome Measures

EEG pattern
EEG patterns depending on size and location of acute ischemic stroke,including generalized or focal slowing or both and epileptiform discharges

Secondary Outcome Measures

Full Information

First Posted
May 27, 2020
Last Updated
March 9, 2021
Sponsor
rambam62
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1. Study Identification

Unique Protocol Identification Number
NCT04412434
Brief Title
EEG Patterns in Patients With Acute Ischemic Stroke Resulted From Large Vessels Occlusion in the Anterior Circulation
Official Title
EEG Patterns in Patients With Acute Ischemic Stroke Resulted From Large Vessels Occlusion in the Anterior Circulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2020 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
rambam62

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
eeg pattern, acute ischemic stroke

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with acute ischemic stroke
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Electroencephalography (EEG)
Intervention Description
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.
Primary Outcome Measure Information:
Title
EEG pattern
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with acute ischemic stroke, due to large vessel occlusion Age of 18 years and more Male or Female Modified Rankin Scale of ≤ 2 prior to presentation NIHSS ≥ 4 at the day of NCT and EEG Exclusion Criteria: Epilepsy Brainstem or cerebellar stroke Intracranial or extracranial hemorrhage of any kind History of severe head trauma History of severe dementia or progressive neurodegenerative disease Cerebral tumor or hydrocephalus by anamnesis or by imaging Lacunar stroke Significant movement disorder. Local skull or skin condition, preventing EEG electrode application. Any known disorder, which may interfere with the protocol implementation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory Telman, MD
Phone
972-47772161
Email
g_telman@rmc.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Svetlana Afanasiev, MPH
Phone
972-47771926
Email
s_afanasiev@rmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Telman, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam MC
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Telman, MD
Phone
97247772161
Email
g_telman@rmc.gov.il
First Name & Middle Initial & Last Name & Degree
Svetlana Afanasiev, MPH
Phone
972-47771926
Email
s_afanasiev@rmc.gov.il

12. IPD Sharing Statement

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EEG Patterns in Patients With Acute Ischemic Stroke Resulted From Large Vessels Occlusion in the Anterior Circulation

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