Brain Areas of Time-To-Contact Perception: an Awake Surgery Study

NCT04128306 | Recruiting

• 1 other identifier: RC31/18/0240
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

During a brain surgery targeted to remove a brain tumor, the neurosurgeon wakes up the patient to delimit the tumor area exactly, and identify the surrounding areas, to limit the surgery damages. The present project aims at testing the patient in this awake phase to determine the brain areas implied in time to contact (TTC) perception, a function that allows determining the arrival time of moving objects and used in many tasks of our daily life.

Conditions

Brain Tumors

Keywords

Time to contact estimation; awake brain surgery; brain tumor; cerebral mapping

Outcome Measures

Primary Outcomes (1)

• Cerebral mapping

  Look at how the cognitive functions of perception of time before contact are attached to brain structures, their communication with other zones, their alteration due to brain tumors for patients with a brain tumor compared to control subjects. The treatment of the study being an awakened awakening as part of the routine care, there is no risk of serious adverse event. Brain mapping will be done through neurological examinations which are questionnaires and a risk-free task. All the tasks and all the questionnaires described in the paragraph "arm and intervention" will make it possible to meet this outcome.

  61 months

Secondary Outcomes (1)

• Look the implication of other brain areas

  61 months

Study Arms (2)

Patient group

EXPERIMENTAL

A total of 120 patients with brain tumors will be divided into our two groups, divided as follows: 1. In the group Pre-Per, 20 patients will be included by localization of electrical stimulation (60 patients in total). A patient who would be stimulable in two different areas could be included in two different groups. 2. In the group Pre-End, the subjects will be distributed by localization of the brain tumor, by lobe. A total of 20 participants will be included per lobe, corresponding to the frontal, temporal or parietal lobes (as a reminder, a tumor in the occipital lobe is an exclusion criterion), for a total of 60 participants

Behavioral: Behavioral task; Procedure: Awake surgery; Other: Neurological assessment

Control group

ACTIVE COMPARATOR

A maximum of 120 healthy matched sex and age subjects with patients will also be included

Behavioral: Behavioral task; Other: Neurological assessment

Interventions

Behavioral task BEHAVIORAL

In the task, participants will see an object approaching toward them. During its movement, the object disappears, and the participants have to press a button to indicate when they estimate the object to contact with them. The motion parameters of the ball will be varied. The pre and post-surgery phases will test the participants in a long duration version of the task, approximately 30 minutes. The per surgery phase will be made of a 5 minutes version of the task, and the participants will receive a direct cortical stimulation for 4 seconds, at an intensity of 1 to 10 milliampere (mA), in the premotor ventral area, or posterior parietal cortex or somesthetic associative areas.

Control group; Patient group

Awake surgery PROCEDURE

The patient is first anesthetized for opening the scalp and skull, then awake. During this waking phase, the surgeon passes a few quick and simple tests to the patient, visual (for example, line bisection), language (for example, repeating a list of words) etc. While doing this task, the neurosurgeon disrupts the functioning of certain brain regions by direct electrical stimulation of the cortex in order to identify the regions whose dysfunction will have an impact on the current task. During the operation, the areas involved in the construction of the peri-personal space will be stimulated by direct electrical stimulation, for a duration of 4 seconds at an intensity of 1 to 10 mA. These areas are: * Ventral premotor cortex (with the exception of the primary motor cortex controlling the dominant hand, so as not to interfere with the motor response of the patient) * Posterior parietal cortex * Associative somesthetic areas

Patient group

Neurological assessment OTHER

The Mini Mental State Evaluation, which generally assesses the cognitive state of an individual through his 6 subtests testing both working memory, episodic and semantic praxies as well as spatio-temporal orientation capacity.

Control group; Patient group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For the patients:
• Brain tumor that does not affect the dominant hand motricity. The patient that have a tumor in an area targeted for a cortical stimulation will be automatically enrolled within the Pre-End group.
• Who will agree with all terms and sign the experimental agreement
• Correct or corrected vision, as allowed by the surgery constraints
• Affiliated to a social security system
• For the control group:
• Who will agree with all terms and sign the experimental agreement
• Correct or corrected vision
• With no known oculomotor abnormalities.
• Affiliated to a social security system

You may not qualify if:

• For the patients:
• Brain tumor located in the occipital area
• Legally protected patient, or with unknown ability to sign the experimental agreement, as determined by the medical team.
• Medical background of neurological diseases of the central nervous system, as Parkinson, Alzheimer, stroke
• Pregnancy
• For the control group:
• Legally protected patient, or with unknown ability to sign the experimental agreement, as determined by the medical team.
• Medical background of neurological diseases of the central nervous system, as Parkinson, Alzheimer, stroke
• Pregnancy

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital

Toulouse, 31000, France

RECRUITING

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

Study Officials

• Franck-Emmanuel Roux, MD

  University Hopsital Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Franck-Emmanuel ROUX, MD

CONTACT

(0)5 61 77 93 81; roux.f@chu-toulouse.fr

Robin BAURES

CONTACT

(0)5 62 74 62 15; robin.baures@cnrs.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: October 9, 2019
• First Posted: October 16, 2019
• Study Start: September 16, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)