ElectrocorticographyECoGNCT05875935
Assessment of Awake Surgery With Electrocorticographic Recordings in the Management of Gliomas and Correlation With Imaging Data (ECoG)
A study testing ECoG : electrocorticography in people with Electrocorticography and Karnofski Index, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electrocorticography, Karnofski Index, Glioma
- What is being tested?
- ECoG : electrocorticography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Show all 9Show fewer
- No medical contraindication to surgery and anesthesia;
- Karnofski index> 70;
- Subject having signed an informed consent.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Electrocorticography, Karnofski Index, Glioma
- Being tested
- ECoG : electrocorticography
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECoG : electrocorticographyProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Subject with a non-recurrent glial lesion requiring surgery in vigilance | Experimental | Not described Receives: Procedure: ECoG : electrocorticography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start17 Dec 2021
- Primary completion17 Apr 2022
- Study completion31 May 2022
Why it stopped: Medical device defective
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectrocorticographyStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875935
- Sponsor's protocol ID
- 2019-A02005-52
- Acronym
- ECoG
- Status last verified
- Jul 2026
- First submitted
- 4 May 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Awake Surgery With Electrocorticographic Recordings in the Management of Gliomas and Correlation With Imaging Data
- ClinicalTrials.gov ID
- NCT05875935
- Acronym / sponsor ID
- ECoG / 2019-A02005-52
- Conditions
- Electrocorticography, Karnofski Index, Glioma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Medical device defective
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 17 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject with a non-recurrent glial lesion requiring surgery in vigilance | Experimental | Procedure: ECoG : electrocorticography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECoG : electrocorticographyThe 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). | Procedure or surgery | Subject with a non-recurrent glial lesion requiring surgery in vigilance |
Primary outcome
electrocorticographic recordings
Time frame: 12 months
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.
Results and safety
The study was stopped early (reason given: Medical device defective). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECoG : electrocorticography in people with Electrocorticography and Karnofski Index, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Medical device defective). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
electrocorticographic recordings (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.