NCT05473975

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

January 24, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

July 22, 2022

Last Update Submit

June 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Placement of the EGG before the beginning of the thrombectomy

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique A. de Rothschild

Paris, 75019, France

Location

Study Officials

  • Michael OBADIA

    HOPITAL FONDATION Adolphe de ROTHSCHILD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2022

First Posted

July 26, 2022

Study Start

January 24, 2023

Primary Completion

January 23, 2025

Study Completion

January 23, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations