Search for a Recanalization of the Sylvian Artery Electro-Physiological Biomarker (BEERS)

Early recanalization is a major prognostic factor in vascular accidents ischemic brain injury (AIC). The acute phase therapies of AIC aim to recanalization by intravenous thrombolysis and/or mechanical thrombectomy. Recanalization is identified immediately during thrombectomy by per-procedural arteriography. For the thrombolysis, only a performed MRI will validate the recanalization. This "proof of concept" study aims to identify an Electro-Encephalographic biomarker (EEG) of the recanalization in real time, the EEG being easy to set up. This biomarker will be sought during recanalization certified by thrombectomy in order to identify the window time for which the biomarker must be sought on the EEG. During this study, the identified EEG biomarker can be used to validate the recanalization during the intravenous thrombolysis in future studies

Study Overview

• Status: Completed
• Conditions: AIS
• Intervention / Treatment: Procedure: Placement of the EGG

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Fondation Ophtalmologique A. De Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Inclusions 15 patients hospitalized for an ischemic stroke for whom an MRI identified a proximal sylvian artery occlusion, treatable by mechanical thrombectomy.

Description

Inclusion Criteria:

• Patient over 18 years old
• Presenting a cerebral infarction with proximal occlusion of the sylvian artery requiring thrombectomy
• No objection to participation in the study

Exclusion Criteria:

• Pregnant or breastfeeding women
• Patient benefiting from legal protection
• Absence of affiliation to a social protection scheme
• Recent cranial surgery not allowing the installation of a scalp EEG

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IElectro-Encephalographic (EEG) marker of recanalization	dentification of an Electro-Encephalographic (EEG) marker of recanalization in patients with cerebral infarction with proximal occlusion of the sylvian artery and recanalized by mechanical thrombectomy	inclusion visit

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Michael OBADIA, Hôpital Fondation Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2023
• Primary Completion (Actual): January 23, 2025
• Study Completion (Actual): January 23, 2025

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: MOA_2022_3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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