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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05473975

Collaborator

(none)

Enrollment

5.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cerebral Infarction With Proximal Occlusion of the Sylvian Artery and Recanalized by Mechanical Thrombectomy	Procedure: Placement of the EGG

Study Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Outcome Measures

Primary Outcome Measures

IElectro-Encephalographic (EEG) marker of recanalization [inclusion visit]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondation Ophtalmologique Adolphe de Rothschild

ClinicalTrials.gov Identifier:

NCT05473975

Other Study ID Numbers:

MOA_2022_3

First Posted:

Jul 26, 2022

Last Update Posted:

Jul 26, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cerebral Infarction

Infarction

Study Results

No Results Posted as of Jul 26, 2022