Cerebral TumorBRAIN-MAPNCT07170436
Brain Areas of Cognitive Functions: a Study in Awake Surgery
A study testing Short version of cognitive testing during surgery in people with Cerebral Tumor, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This research project focuses on low-level cognitive functions such as perception (auditory, visual, etc.) and high-level cognitive functions (memory, language, temporal estimation, etc.). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebral Tumor
- What is being tested?
- Short version of cognitive testing during surgery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2025to 8 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a brain tumor
- Aged 18 to 75 years
- Signed informed consent
- Vision that is corrected or adequate for the purposes of an experiment with visual stimuli
- Hearing that is corrected or adequate for the purposes of an experiment with auditory stimuli
- No known oculomotor disorder
- Person affiliated with or benefiting from a social security scheme.
- Free, informed, and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research)
Who cannot join
- Participants under protected status: guardianship, legal safeguard proceedings, or whose consent to participate in the experiment could be due to a severely altered psychological state, as determined by the medical team responsible for the surgery.
- History of neurological disease affecting the central nervous system (Parkinson's, Alzheimer's, history of stroke or cerebral infarction)
- Pregnant and/or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service de Neurochirurgie, Hôpital Pierre Paul Riquet, Place du Docteur Baylac
Toulouse, Oui, 31300
Emeline Muller, 0561778707 ext. +33, muller.e@chu-toulouse.fr
muller.e@chu-toulouse.fr
About this study
This research project focuses on low-level cognitive functions such as perception (auditory, visual, etc.) and high-level cognitive functions (memory, language, temporal estimation, etc.). It aims to better understand the brain bases of these functions as well as their overlap (i.e., brain bases considered to be involved in different functions).
To this end, various cognitive tasks will be performed before and during awake brain surgery, allowing us to determine the involvement of different areas in the task being performed. Comparing performance between the pre-test and the intraoperative test will help determine the potential involvement of the tested area.
- Conditions
- Cerebral Tumor
- Being tested
- Short version of cognitive testing during surgery
- Keywords
- surgery, awake surgery, brain, brain tumor, brain area
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short version of cognitive testing during surgeryBehavioural
Cognitive testing in 3 blocks of 3 minutes during awake surgery
| Study group | Role | What they receive |
|---|---|---|
| Pré-End | No intervention | The day before surgery, brain tumor patients will be offered long-form cognitive tests. If the results of the cognitive tests are not consistent with the literature, this suggests that the tumor is affecting pre-contact time perception. These patients will not be tested during surgery. |
| Pré-Per | Experimental | The day before surgery, brain tumor patients will be offered long-form cognitive tests. If the results of the cognitive tests are consistent with the literature, the short-form cognitive tests will be offered during awake surgery. Receives: Behavioral: Short version of cognitive testing during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of an atlas mapping the brain regions involved in each major cognitive function
Analysis of the percentage of "yes" responses during the intraoperative phase, taking into account the expected probability based on preoperative results. Preoperative performance data allows to determine an expected performance level during the intraoperative phase.
Measured: One day after the inclusion
Secondary outcomes (2)
Number of tests
number of tests for which a brain area is considered to be involved during the analysis of the primary criterion for the pre-per group
Measured: One day after the inclusion
Location of brain tumors
The MRI images of patients in the Pre-End group will be analyzed. It will be possible to determine whether their tumors overlap in a specific area, which could indicate that this area is essential for the process being studied.
Measured: one day after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2030 (estimated)
- Study completion8 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral TumorStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170436
- Sponsor's protocol ID
- RC31/25/0226
- Other IDs
- ID-RCB
- Acronym
- BRAIN-MAP
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Areas of Cognitive Functions: a Study in Awake Surgery
- ClinicalTrials.gov ID
- NCT07170436
- Acronym / sponsor ID
- BRAIN-MAP / RC31/25/0226
- Conditions
- Cerebral Tumor
- Keywords
- surgery, awake surgery, brain, brain tumor, brain area
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2030 (estimated)
- Study completion
- 8 Nov 2030 (estimated)
- First posted
- 12 Sep 2025 (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 research project focuses on low-level cognitive functions such as perception (auditory, visual, etc.) and high-level cognitive functions (memory, language, temporal estimation, etc.). It aims to better understand the brain bases of these functions as well as their overlap (i.e., brain bases considered to be involved in different functions).
To this end, various cognitive tasks will be performed before and during awake brain surgery, allowing us to determine the involvement of different areas in the task being performed. Comparing performance between the pre-test and the intraoperative test will help determine the potential involvement of the tested area.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pré-End | No intervention | –The day before surgery, brain tumor patients will be offered long-form cognitive tests. If the results of the cognitive tests are not consistent with the literature, this suggests that the tumor is affecting pre-contact time perception. These patients will not be tested during surgery. |
| Pré-Per | Experimental | Behavioral: Short version of cognitive testing during surgeryThe day before surgery, brain tumor patients will be offered long-form cognitive tests. If the results of the cognitive tests are consistent with the literature, the short-form cognitive tests will be offered during awake surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with a brain tumor
- Aged 18 to 75 years
- Signed informed consent
- Vision that is corrected or adequate for the purposes of an experiment with visual stimuli
- Hearing that is corrected or adequate for the purposes of an experiment with auditory stimuli
Key exclusion criteria (3 listed)
- Participants under protected status: guardianship, legal safeguard proceedings, or whose consent to participate in the experiment could be due to a severely altered psychological state, as determined by the medical team responsible for the surgery.
- History of neurological disease affecting the central nervous system (Parkinson's, Alzheimer's, history of stroke or cerebral infarction)
- Pregnant and/or breastfeeding women.
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 |
|---|---|---|
| Short version of cognitive testing during surgeryCognitive testing in 3 blocks of 3 minutes during awake surgery | Behavioural | Pré-Per |
Primary outcome
development of an atlas mapping the brain regions involved in each major cognitive function
Time frame: One day after the inclusion
Analysis of the percentage of "yes" responses during the intraoperative phase, taking into account the expected probability based on preoperative results. Preoperative performance data allows to determine an expected performance level during the intraoperative phase.
2 secondary outcomes
Number of tests
Time frame: One day after the inclusion
Location of brain tumors
Time frame: one day after the inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short version of cognitive testing during surgery in people with Cerebral Tumor, run by University Hospital, Toulouse 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 8 inclusion and 3 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: opening soon, as of the sponsor's last update on 12 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Franck Emmanuel ROUX, PHD (05 61 77 93 81 ext. +33, roux.F@chu-toulouse.Fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development of an atlas mapping the brain regions involved in each major cognitive function (time frame: One day after the inclusion). 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 12 Sep 2025.