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

NCT04412434 | Unknown

• 1 other identifier: 0297-20 RMB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke, Ischemic

Keywords

eeg pattern; acute ischemic stroke

Outcome Measures

Primary Outcomes (1)

• EEG pattern

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

  24 months

Study Arms (1)

patients with acute ischemic stroke

OTHER

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)

Interventions

Electroencephalography (EEG) DIAGNOSTIC_TEST

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.

patients with acute ischemic stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• rambam62: lead

Study Sites (1)

Rambam MC

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Gregory Telman, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory Telman, MD

CONTACT

972-47772161; g_telman@rmc.gov.il

Svetlana Afanasiev, MPH

CONTACT

972-47771926; s_afanasiev@rmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of Stroke Service, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 2, 2020
• Study Start: October 4, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

IL (1)