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CompletedNCT02903784BNLUpdated Sep 2, 2020

Neural Basis of Language Processing

An interventional study of fMRI and tractography in Oligoastrocytoma, Astrocytoma and Oligodendroglioma, sponsored by University Hospital, Montpellier. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-09-02.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Oligoastrocytoma
  • Astrocytoma
  • Oligodendroglioma
03

In context

Astrocytoma

420 studies on the registry are indexed under Astrocytoma; 76 are open to participants now.

This study's enrollment of 63 is above the median of 30 across 346 interventional studies indexed under Astrocytoma.

Browse Astrocytoma studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Other
    grade 2 glioma

    Patient with grade 2 glioma use a neuropsychological examination and brain imaging (fMRI and tractography)

    Device: fMRI · Procedure: tractography · Other: neuropsychological examination

  • Other
    healthy volunteers

    healthy volunteers use a neuropsychological examination and brain imaging (fMRI and tractography)

    Device: fMRI · Procedure: tractography · Other: neuropsychological examination

Interventions

  • DevicefMRI

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

  • Proceduretractography

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

  • Otherneuropsychological examination

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

Secondary outcomes

  1. 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

    Time frame: 1 day

  2. 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

    Time frame: 5 day

  3. 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

    Time frame: 3 month

  4. Imagery Data

    Imagery Data

    Time frame: 1 day

  5. Imagery Data

    Imagery Data

    Time frame: 5 day

  6. Imagery Data

    Imagery Data

    Time frame: 6 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02903784
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Sep 16, 2016
Start date
Sep 2012
Primary completion
Feb 2015
Completion
Sep 2016
Last update
Sep 2, 2020

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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