BNL: Neural Basis of Language Processing

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT02903784
Collaborator
(none)
63
2
48

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: fMRI
  • Procedure: tractography
  • Other: neuropsychological examination
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Neural Basis of Language: A New Lighting. Study of Semantic Processing in MRI Mutimodale and Direct Electrical Stimulation
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. functional score [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 Outcome Measures

  1. Evaluation orthophonic [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 [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 [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 [1 day]

    Imagery Data

  5. Imagery Data [5 day]

    Imagery Data

  6. Imagery Data [6 month]

    Imagery Data

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Montpellier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT02903784
Other Study ID Numbers:
  • 8674
First Posted:
Sep 16, 2016
Last Update Posted:
Sep 2, 2020
Last Verified:
May 1, 2011
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 2, 2020