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Completed

NCT Number: NCT02903784

Neural Basis of Language Processing

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fMRI

Device

Patient with grade 2 glioma and healthy volunteers use a brain imaging (fMRI)

tractography

Procedure

Patient with grade 2 glioma and healthy volunteers use a brain imaging (tractography)

Neuropsychological examination

Other

Patient with grade 2 glioma and healthy volunteers use a neuropsychological examination

Primary outcomes

  1. functional score

    Time frame: 1 day

    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 outcomes

  1. Evaluation orthophonic

    Time frame: 1 day

    • 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
  2. Evaluation orthophonic

    Time frame: 5 day

    • 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. Evaluation orthophonic

    Time frame: 3 month

    • 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
  4. Imagery Data

    Time frame: 1 day

    Imagery Data

  5. Imagery Data

    Time frame: 5 day

    Imagery Data

  6. Imagery Data

    Time frame: 6 month

    Imagery Data

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: BNL

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Sep 16, 2016
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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