Neural Basis of Language Processing

NCT ID: NCT02903784

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-09-30

Brief Summary

According to the O.M.S. Classification, grade 2 glioma is a pre-cancerous lesion, slowly progressive, infiltrating the central nervous system, mainly affecting young adults.

This surgery should nevertheless be conducted in awake condition to achieve two conflicting goals: get maximum brain tissue infiltrated by the tumor while preserving the integrity of functional structures. So awake after opening the skull, the patient undergoes a series of preoperative tests, administered by a speech therapist present in the operating room. This procedure allows the neurosurgeon to establish an individual functional brain mapping in real time, through the observation by the SLP of the patient's answers to direct electrical stimulation applied to the cortical and sub-cortical. This support is based on the extraordinary plasticity demonstrated by the brain in the presence of a slowly progressive lesion. To ensure the patient the highest achievable load should increase our understanding of brain function, including the neural bases of language, glioma grade 2 is predominantly localized functional area of language.

Detailed Description

According to the O.M.S. Classification, grade 2 glioma is a pre-cancerous lesion, slowly progressive, infiltrating the central nervous system, mainly affecting young adults. Surgical excision of the tumor is the most appropriate care, with or without chemotherapy or radiotherapy.

This surgery should nevertheless be conducted in awake condition to achieve two conflicting goals: get maximum brain tissue infiltrated by the tumor while preserving the integrity of functional structures. So awake after opening the skull, the patient undergoes a series of preoperative tests (motor, sensory and / or language), administered by a speech therapist present in the operating room. This procedure allows the neurosurgeon to establish an individual functional brain mapping in real time, through the observation by the SLP of the patient's answers to direct electrical stimulation applied to the cortical and sub-cortical. This support is based on the extraordinary plasticity demonstrated by the brain in the presence of a slowly progressive lesion. To ensure the patient the highest achievable load should increase our understanding of brain function, including the neural bases of language, glioma grade 2 is predominantly localized functional area of language. Many studies apply to highlight the cortical organization of language, but the study of subcortical beams involved in this function, especially in the semantic language processing, has so far received less attention .

The use of electric direct intraoperative stimulation helps highlight the cortico-subcortical networks involved in language processing.

The new imaging techniques allow us to better understand the functional brain anatomy: the Diffusion Tensor can view the white matter bundles based on the diffusion of water molecules, functional MRI to visualize areas cortical functional.

Conditions

Oligoastrocytoma; Astrocytoma; Oligodendroglioma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

grade 2 glioma

Patient with grade 2 glioma use a neuropsychological examination and brain imaging (fMRI and tractography)

Group Type: OTHER

fMRI

Intervention Type: DEVICE

Patient with grade 2 glioma and healthy volunteers use a brain imaging (fMRI)

tractography

Intervention Type: PROCEDURE

Patient with grade 2 glioma and healthy volunteers use a brain imaging (tractography)

neuropsychological examination

Intervention Type: OTHER

Patient with grade 2 glioma and healthy volunteers use a neuropsychological examination

healthy volunteers

healthy volunteers use a neuropsychological examination and brain imaging (fMRI and tractography)

Group Type: OTHER

fMRI

Intervention Type: DEVICE

Patient with grade 2 glioma and healthy volunteers use a brain imaging (fMRI)

tractography

Intervention Type: PROCEDURE

Patient with grade 2 glioma and healthy volunteers use a brain imaging (tractography)

neuropsychological examination

Intervention Type: OTHER

Patient with grade 2 glioma and healthy volunteers use a neuropsychological examination

Interventions

fMRI

Patient with grade 2 glioma and healthy volunteers use a brain imaging (fMRI)

Intervention Type: DEVICE

tractography

Patient with grade 2 glioma and healthy volunteers use a brain imaging (tractography)

Intervention Type: PROCEDURE

neuropsychological examination

Patient with grade 2 glioma and healthy volunteers use a neuropsychological examination

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients carry a grade glioma 2 functional area of language and presenting the information to receive surgical care provided in awake for the first time.

or Healthy volunteers will be selected using a matching age and sex of patients in the study (matched to a patient on two of the first forty patients).

Exclusion Criteria

• Subject presenting cons-indications to MRI (ventricular shunt valve, ferromagnetic foreign bodies, pacemaker, implantable defibrillators, cochlear hearing implant, claustrophobia, ....)
• History of head trauma, ischemic stroke or intracerebral hematoma.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

8674

Identifier Type: -

Identifier Source: org_study_id