Neural Basis of Language Processing (BNL)

The Neural Basis of Language: A New Lighting. Study of Semantic Processing in MRI Mutimodale and Direct Electrical Stimulation

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.

Study Overview

• Status: Completed
• Conditions: Astrocytoma; Oligoastrocytoma; Oligodendroglioma
• Intervention / Treatment: Device: fMRI; Procedure: tractography; Other: neuropsychological examination

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: grade 2 glioma; Patient with grade 2 glioma use a neuropsychological examination and brain imaging (fMRI and tractography)	Device: fMRI; Patient with grade 2 glioma and healthy volunteers use a brain imaging (fMRI); Procedure: tractography; Patient with grade 2 glioma and healthy volunteers use a brain imaging (tractography); Other: neuropsychological examination; Patient with grade 2 glioma and healthy volunteers use a neuropsychological examination
Other: healthy volunteers; healthy volunteers use a neuropsychological examination and brain imaging (fMRI and tractography)	Device: fMRI; Patient with grade 2 glioma and healthy volunteers use a brain imaging (fMRI); Procedure: tractography; Patient with grade 2 glioma and healthy volunteers use a brain imaging (tractography); Other: neuropsychological examination; Patient with grade 2 glioma and healthy volunteers use a neuropsychological examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional score	The intraoperative testing is performed by an evaluator (speech / neuropsychologist), present in the operating room, the patient's side. Its role is to identify functional disturbances induced by direct electrical stimulation. To do this, two standardized tests are administered to the patient alternately for the duration of the awake period. These tests are presented on a computer screen in PowerPoint format, with a picture every four seconds.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation orthophonic	Spontaneous Speech; Test oral denomination: DO. 80 with computerized measurement of reaction time; Verbal FluenceCategorical: animalsFormal: letter / p /; Test semantic matching: PPTT with computerized measurement of the reaction time; trial test semantics / phonology; Image Designation	1 day
Evaluation orthophonic	Spontaneous Speech; Test oral denomination: DO. 80 with computerized measurement of reaction time; Verbal FluenceCategorical: animalsFormal: letter / p /; Test semantic matching: PPTT with computerized measurement of the reaction time; trial test semantics / phonology; Image Designation	5 day
Evaluation orthophonic	Spontaneous Speech; Test oral denomination: DO. 80 with computerized measurement of reaction time; Verbal FluenceCategorical: animalsFormal: letter / p /; Test semantic matching: PPTT with computerized measurement of the reaction time; trial test semantics / phonology; Image Designation	3 month
Imagery Data	Imagery Data	1 day
Imagery Data	Imagery Data	5 day
Imagery Data	Imagery Data	6 month

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 13, 2016
• First Submitted That Met QC Criteria: September 15, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Astrocytoma; Oligodendroglioma
• Other Study ID Numbers: 8674

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED