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Not yet recruiting NCT07170436

Brain Areas of Cognitive Functions: a Study in Awake Surgery

No phase Interventional Cerebral Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Short version of cognitive testing during surgery.
Who it may be relevant to
Registry conditions: Cerebral Tumor. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Short version of cognitive testing during surgery
    Cognitive testing in 3 blocks of 3 minutes during awake surgery

Primary outcome measures

  • development of an atlas mapping the brain regions involved in each major cognitive function [Time frame: One day after the inclusion]
Secondary outcome measures (2)
  • Number of tests [Time frame: One day after the inclusion]
  • Location of brain tumors [Time frame: one day after the inclusion]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • Service de Neurochirurgie, Hôpital Pierre Paul Riquet, Place du Docteur Baylac — Toulouse

Identifiers

NCT: NCT07170436 · RC31/25/0226 · ID-RCB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗