Brain Areas of Cognitive Functions: a Study in Awake Surgery

NCT07170436 | Not Yet Recruiting DMC

• 2 other identifiers: RC31/25/0226ID-RCB
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Tumor

Keywords

surgery; awake surgery; brain; brain tumor; brain area

Outcome Measures

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.

  One day after the inclusion

Secondary Outcomes (2)

• Number of tests

  One day after the inclusion

• Location of brain tumors

  one day after the inclusion

Study Arms (2)

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.

Behavioral: Short version of cognitive testing during surgery

Interventions

Short version of cognitive testing during surgery BEHAVIORAL

Cognitive testing in 3 blocks of 3 minutes during awake surgery

Pré-Per

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Service de Neurochirurgie, Hôpital Pierre Paul Riquet, Place du Docteur Baylac

Toulouse, Oui, 31300, France

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Franck Emmanuel ROUX, PHD

CONTACT

05 61 77 93 81; roux.F@chu-toulouse.Fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 12, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 8, 2030
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)