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

Glioma Clinical Trial

— ECoG  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05875935
• Other study ID #: 2019-A02005-52
• Status: Terminated
• Phase: N/A
• Start date: December 17, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: May 2023
• Source: Ramsay Générale de Santé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 31, 2022
• Est. primary completion date: April 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Glioma

Intervention

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).

Locations

Country	Name	City	State
France	Clairval Private Hospital	Marseille	Paca

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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