Brain Areas of Cognitive Functions: a Study in Awake Surgery
ConditionCerebral Tumor
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital, Toulouse
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Short version of cognitive testing during surgery
BehavioralCognitive testing in 3 blocks of 3 minutes during awake surgery
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Pré-EndNo intervention 0 interventions
Group B: Pré-PerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
One day after the inclusionSecondary outcomes
1
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
Time frame
One day after the inclusion2
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.
Time frame
one day after the inclusionSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: