Brain Areas of Cognitive Functions: a Study in Awake Surgery

NCT ID: NCT07170436

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2030-11-08

Brief Summary

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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

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Conditions

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Cerebral Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Pré-End

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Pré-Per

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.

Group Type EXPERIMENTAL

Short version of cognitive testing during surgery

Intervention Type BEHAVIORAL

Cognitive testing in 3 blocks of 3 minutes during awake surgery

Interventions

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Short version of cognitive testing during surgery

Cognitive testing in 3 blocks of 3 minutes during awake surgery

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Toulouse, Oui, France

Site Status

Countries

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France

Central Contacts

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Franck Emmanuel ROUX, PHD

Role: CONTACT

05 61 77 93 81 ext. +33

Facility Contacts

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Emeline Muller

Role: primary

0561778707 ext. +33

Role: backup

Other Identifiers

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ID-RCB

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/25/0226

Identifier Type: -

Identifier Source: org_study_id

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