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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
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Oligoastrocytoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 13, 2016
    Last Updated
    September 1, 2020
    Sponsor
    University Hospital, Montpellier
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    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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