Assessment of Awake Surgery With Electrocorticographic Recordings in the Management of Gliomas and Correlation With Imaging Data (ECoG)

NCT ID: NCT05875935

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-17
• Study Completion Date: 2022-05-31

Brief Summary

This study proposes to analyze data from intraoperative ECoG recordings acquired during wakefulness interventions in order to identify the connection networks involved in cognitive functions. This study also proposes to correlate the ECoG data with the imaging data and to analyze the disturbances of the electrophysiological signals induced by the cortical and subcortical brain lesions: this will make it possible to establish a more detailed mapping of the tumor areas and to compare disturbances recorded to those recorded in healthy areas. Thus, this approach should make it possible to improve the quality of excision of glial lesions located in eloquent areas, while reducing the risk of neurological sequelae and thus improve the survival and quality of life of patients.

Conditions

Electrocorticography; Karnofski Index; Glioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Subject with a non-recurrent glial lesion requiring surgery in vigilance

Group Type: EXPERIMENTAL

ECoG : electrocorticography

Intervention Type: PROCEDURE

The skull and the dura are opened under general anesthesia and the two grids of 64 cortical electrodes will be applied to the cortex, one facing the glial lesion, and the other at a distance from the glial lesion in the so-called area. "Healthy" (non-tumor), before the patient wakes up. They consist of 8 recording slides each comprising 8 electrodes of 2 mm in diameter each spaced 0.5 mm (DispoMed®, USA).

Interventions

ECoG : electrocorticography

The skull and the dura are opened under general anesthesia and the two grids of 64 cortical electrodes will be applied to the cortex, one facing the glial lesion, and the other at a distance from the glial lesion in the so-called area. "Healthy" (non-tumor), before the patient wakes up. They consist of 8 recording slides each comprising 8 electrodes of 2 mm in diameter each spaced 0.5 mm (DispoMed®, USA).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Man or woman over 18 years-old
• Subject with a non-recurrent glial lesion requiring surgery in vigilant condition;
• Brain lesion located in the functional zone;
• Major not protected within the meaning of the law;
• Subject affiliated to a Health Insurance scheme;
• No medical contraindication to performing an MRI (pacemaker);
• No medical contraindication to surgery and anesthesia;
• Karnofski index> 70;
• Subject having signed an informed consent.

Exclusion Criteria

• Minor subject, pregnant or breastfeeding woman;
• Major subject subject under measure of legal protection, guardianship or deprived of liberty by judicial or administrative decision;
• Subject hospitalized without consent;
• Subject treated with antipsychotics (neuroleptic or lithium);
• Subject who has already been treated for his glial lesion by surgery and / or radiotherapy;
• Subject refusing to sign an informed consent.
• Subject wishing to discontinue participation in the study before completion;
• Subject for which the surgical intervention and / or the ECoG recording could not be carried out after admission to the operating room (whatever the reason).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Clinical Trial Experts Network

OTHER

Sponsor Role: collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clairval Private Hospital

Marseille, Paca, France

Countries

France

Other Identifiers

2019-A02005-52

Identifier Type: -

Identifier Source: org_study_id