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

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

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.

Study Overview

• Status: Terminated
• Conditions: Glioma; Electrocorticography; Karnofski Index
• Intervention / Treatment: Procedure: ECoG : electrocorticography

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paca
    • Marseille, Paca, France, 13009
      • Clairval Private Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
electrocorticographic recordings	Intraoperative ECoG recordings (raw signals) acquired during awake surgery which in clinical practice couples cortical stimulation and simultaneous ECoG recordings with behavioral tests. The regions defined as electrophysiologically "connected" to the stimulated region will be those for which an afterdischarge is recorded (short-duration rhythmic activity following the stimulation) and/or a cortico-cortical evoked potential is obtained after a average of 5 successive stimulations.	12 months

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2021
• Primary Completion (Actual): April 17, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: 2019-A02005-52

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No