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Brain Areas of Cognitive Functions: a Study in Awake Surgery (BRAIN-MAP)

T

Toulouse University Hospital

Status

Not yet enrolling

Conditions

Cerebral Tumor

Treatments

Behavioral: Short version of cognitive testing during surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT07170436
RC31/25/0226
ID-RCB (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Pré-End
No Intervention group
Description:
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 group
Description:
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.
Treatment:
Behavioral: Short version of cognitive testing during surgery

Trial contacts and locations

1

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Central trial contact

Franck Emmanuel ROUX, PHD

Data sourced from clinicaltrials.gov

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