Clinical trial NCT02903784: Neural Basis of Language Processing
Official title: The Neural Basis of Language: A New Lighting. Study of Semantic Processing in MRI Mutimodale and Direct Electrical Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oligoastrocytoma
Astrocytoma
Oligodendroglioma
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: functional score
timeFrame: 1 day
Secondary outcomes:
measure: Evaluation orthophonic
timeFrame: 1 day
measure: Evaluation orthophonic
timeFrame: 5 day
measure: Evaluation orthophonic
timeFrame: 3 month
measure: Imagery Data
timeFrame: 1 day
measure: Imagery Data
timeFrame: 5 day
measure: Imagery Data
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
References: