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NCT Number: NCT07170436

Brain Areas of Cognitive Functions: a Study in Awake Surgery

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.

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Key information

Conditions

Cerebral Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Short version of cognitive testing during surgery

Behavioral

Cognitive testing in 3 blocks of 3 minutes during awake surgery

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of tests

    Time frame: 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

  2. Location of brain tumors

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Franck Emmanuel ROUX, PHD

CONTACT

[email protected]

05 61 77 93 81 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: BRAIN-MAP

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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