Back to resultsAssessment of Awake Surgery With Electrocorticographic Recordings in the Management of Gliomas and Correlation With Imaging Data (ECoG) (ECoG)
Primary Purpose
Electrocorticography, Karnofski Index, Glioma
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ECoG : electrocorticography
Sponsored by
About this trial
This is an interventional screening trial for Electrocorticography
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).
Sites / Locations
- Clairval Private Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subject with a non-recurrent glial lesion requiring surgery in vigilance
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05875935
First Posted
May 4, 2023
Last Updated
May 16, 2023
Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
1. Study Identification
Unique Protocol Identification Number
NCT05875935
Brief Title
Assessment of Awake Surgery With Electrocorticographic Recordings in the Management of Gliomas and Correlation With Imaging Data (ECoG)
Acronym
ECoG
Official Title
Assessment of Awake Surgery With Electrocorticographic Recordings in the Management of Gliomas and Correlation With Imaging Data
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Medical device defective
Study Start Date
December 17, 2021 (Actual)
Primary Completion Date
April 17, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Electrocorticography, Karnofski Index, Glioma
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subject with a non-recurrent glial lesion requiring surgery in vigilance
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
ECoG : electrocorticography
Intervention Description
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).
Primary Outcome Measure Information:
Title
electrocorticographic recordings
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Clairval Private Hospital
City
Marseille
State/Province
Paca
ZIP/Postal Code
13009
Country
France
12. IPD Sharing Statement
Learn more about this trial
Assessment of Awake Surgery With Electrocorticographic Recordings in the Management of Gliomas and Correlation With Imaging Data (ECoG)
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