Brain Areas of Cognitive Functions: a Study in Awake Surgery

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Brain Areas of Cognitive Functions: a Study in Awake Surgery

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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)
Exclusion Criteria:
- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07170436
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital, Toulouse
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cerebral Tumor

Arms & Interventions

Arms

No Intervention: Pré-End

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.

Experimental: Pré-Per

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.

Interventions

Behavioral: - Short version of cognitive testing during surgery

Cognitive testing in 3 blocks of 3 minutes during awake surgery

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.