Neural Basis of Language Processing (BNL)
Primary Purpose
Oligoastrocytoma, Astrocytoma, Oligodendroglioma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fMRI
tractography
neuropsychological examination
Sponsored by
About this trial
This is an interventional other trial for Oligoastrocytoma
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
grade 2 glioma
healthy volunteers
Arm Description
Patient with grade 2 glioma use a neuropsychological examination and brain imaging (fMRI and tractography)
healthy volunteers use a neuropsychological examination and brain imaging (fMRI and tractography)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
Imagery Data
Imagery Data
Imagery Data
Imagery Data
Imagery Data
Imagery Data
Full Information
NCT ID
NCT02903784
First Posted
September 13, 2016
Last Updated
September 1, 2020
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02903784
Brief Title
Neural Basis of Language Processing
Acronym
BNL
Official Title
The Neural Basis of Language: A New Lighting. Study of Semantic Processing in MRI Mutimodale and Direct Electrical Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligoastrocytoma, Astrocytoma, Oligodendroglioma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
grade 2 glioma
Arm Type
Other
Arm Description
Patient with grade 2 glioma use a neuropsychological examination and brain imaging (fMRI and tractography)
Arm Title
healthy volunteers
Arm Type
Other
Arm Description
healthy volunteers use a neuropsychological examination and brain imaging (fMRI and tractography)
Intervention Type
Device
Intervention Name(s)
fMRI
Intervention Description
Patient with grade 2 glioma and healthy volunteers use a brain imaging (fMRI)
Intervention Type
Procedure
Intervention Name(s)
tractography
Intervention Description
Patient with grade 2 glioma and healthy volunteers use a brain imaging (tractography)
Intervention Type
Other
Intervention Name(s)
neuropsychological examination
Intervention Description
Patient with grade 2 glioma and healthy volunteers use a neuropsychological examination
Primary Outcome Measure Information:
Title
functional score
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Evaluation orthophonic
Description
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
Time Frame
1 day
Title
Evaluation orthophonic
Description
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
Time Frame
5 day
Title
Evaluation orthophonic
Description
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
Time Frame
3 month
Title
Imagery Data
Description
Imagery Data
Time Frame
1 day
Title
Imagery Data
Description
Imagery Data
Time Frame
5 day
Title
Imagery Data
Description
Imagery Data
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Neural Basis of Language Processing
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