Neural Basis of Language Processing

Astrocytoma Clinical Trial

— BNL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903784
• Other study ID #: 8674
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: September 2016

Study information

• Verified date: May 2011
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astrocytoma
• Oligoastrocytoma
• Oligodendroglioma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation orthophonic	Spontaneous Speech; Test oral denomination: DO. 80 with computerized measurement of reaction time; Verbal Fluence; Categorical: animals; Formal: letter / p /; Test semantic matching: PPTT with computerized measurement of the reaction time; trial test semantics / phonology; Image Designation	1 day
Secondary	Evaluation orthophonic	Spontaneous Speech; Test oral denomination: DO. 80 with computerized measurement of reaction time; Verbal Fluence; Categorical: animals; Formal: letter / p /; Test semantic matching: PPTT with computerized measurement of the reaction time; trial test semantics / phonology; Image Designation	5 day
Secondary	Evaluation orthophonic	Spontaneous Speech; Test oral denomination: DO. 80 with computerized measurement of reaction time; Verbal Fluence; Categorical: animals; Formal: letter / p /; Test semantic matching: PPTT with computerized measurement of the reaction time; trial test semantics / phonology; Image Designation	3 month
Secondary	Imagery Data	Imagery Data	1 day
Secondary	Imagery Data	Imagery Data	5 day
Secondary	Imagery Data	Imagery Data	6 month