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

AIS Clinical Trial

— BEERS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05473975
• Other study ID #: MOA_2022_3
• Status: Recruiting
• Start date: January 24, 2023
• Est. completion date: July 23, 2025

Study information

• Verified date: November 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Amélie YAVCHITZ
• Phone: 01 48 03 64 54
• Email: ayavhitz[@]for.paris
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 23, 2025
• Est. primary completion date: January 23, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AIS

Intervention

Procedure:
• Placement of the EGG
Placement of the EGG before the beginning of the thrombectomy

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A. de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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