Brain Areas of Cognitive Functions: a Study in Awake Surgery

Not Applicable

Not yet recruiting

• Conditions: Cerebral Tumor

• Registration Number: NCT07170436
• Lead Sponsor: University Hospital, Toulouse

Brief 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.). 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-03
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Study Start: 2025-11-01
• Primary Completion: 2030-11-01
• Study Completion: 2030-11-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
development of an atlas mapping the brain regions involved in each major cognitive function	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.

Secondary Outcome Measures

Name	Time	Method
Number of tests	One day after the inclusion	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
Location of brain tumors	one day after the inclusion	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.

Trial Locations

Locations (1)

Service de Neurochirurgie, Hôpital Pierre Paul Riquet, Place du Docteur Baylac; 🇫🇷 Toulouse, Oui, France