Tumoral or Epileptical CortectomyBRAINSPEAKNCT02783391
Pre and Per-operative Electrophysiological Cartography of Speech Area With Cortical Electrode Matrices
A study testing ECoG and intracortical electrodes in people with Tumoral or Epileptical Cortectomy, run by University Hospital, Grenoble at 1 site in France.
Trial summary
New method for speech area cartography in patient individual cortical anatomy in view of improving functional area limit preservation during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumoral or Epileptical Cortectomy
- What is being tested?
- ECoG and intracortical electrodes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Sep 2021
- 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
- Patients needing cortectomy
- Male or female aged over 18 years
- Registered in the French social security scheme
- Signed informed consent
Who cannot join
- •All categories of protected persons
Trial locations and contacts
1 site in 1 country.
Stéphan CHABARDES, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
Grenoble University Hospital
Grenoble, 38000
Stéphan CHABARDES, MD, PhD, SChabardes@chu-grenoble.fr
Caroline Sandre-Ballester, PhD, csandreballester@chu-grenoble.fr
About this study
New method for speech area cartography in patient individual cortical anatomy in view of improving functional area limit preservation during surgery.
- Conditions
- Tumoral or Epileptical Cortectomy
- Being tested
- ECoG and intracortical electrodes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECoG and intracortical electrodesDevice
| Study group | Role | What they receive |
|---|---|---|
| BRAINSPEAK | Experimental | Electrocorticographical (ECoG) and intracortical electrodes Receives: Device: ECoG and intracortical electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
electrophysiological recording
Electrophysiological recording of brain Speech Area, using Cortical Electrode Matrices, in order to improve functional area limit preservation during surgery
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startSep 2015
- Primary completionJun 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumoral or Epileptical CortectomyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783391
- Sponsor's protocol ID
- BRAINSPEAK
- Acronym
- BRAINSPEAK
- Status last verified
- Mar 2020
- First submitted
- 12 May 2016
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre and Per-operative Electrophysiological Cartography of Speech Area With Cortical Electrode Matrices
- ClinicalTrials.gov ID
- NCT02783391
- Acronym / sponsor ID
- BRAINSPEAK / BRAINSPEAK
- Conditions
- Tumoral or Epileptical Cortectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 26 May 2016 (estimated)
- 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.
New method for speech area cartography in patient individual cortical anatomy in view of improving functional area limit preservation during surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BRAINSPEAK | Experimental | Device: ECoG and intracortical electrodesElectrocorticographical (ECoG) and intracortical electrodes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients needing cortectomy
- Male or female aged over 18 years
- Registered in the French social security scheme
- Signed informed consent
Key exclusion criteria (1 listed)
- •All categories of protected persons
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 and intracortical electrodes | Device | BRAINSPEAK |
Primary outcome
electrophysiological recording
Time frame: 2 hours
Electrophysiological recording of brain Speech Area, using Cortical Electrode Matrices, in order to improve functional area limit preservation during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: No
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.
Stéphan CHABARDES, MD, PhD contact
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 and intracortical electrodes in people with Tumoral or Epileptical Cortectomy, run by University Hospital, Grenoble 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphan CHABARDES, MD, PhD (SChabardes@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
electrophysiological recording (time frame: 2 hours). 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 25 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.