Neural Basis of Language Processing

NCT02903784 | Completed DMC

• 1 other identifier: 8674
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oligoastrocytoma; Astrocytoma; Oligodendroglioma

Outcome Measures

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.

  1 day

Secondary Outcomes (6)

• Evaluation orthophonic

  1 day

• Evaluation orthophonic

  5 day

• Evaluation orthophonic

  3 month

• Imagery Data

  1 day

• Imagery Data

  5 day

Study Arms (2)

grade 2 glioma

OTHER

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

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

healthy volunteers

OTHER

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

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

Interventions

fMRI DEVICE

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

grade 2 glioma; healthy volunteers

tractography PROCEDURE

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

grade 2 glioma; healthy volunteers

neuropsychological examination OTHER

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

grade 2 glioma; healthy volunteers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

MeSH Terms

Conditions

Astrocytoma; Oligodendroglioma

Interventions

Magnetic Resonance Imaging; Diffusion Tensor Imaging; Neuropsychological Tests

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Neuroimaging; Diffusion Magnetic Resonance Imaging; Diagnostic Techniques, Neurological; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 16, 2016
• Study Start: September 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: September 1, 2016
• Last Updated: September 2, 2020

Record last verified: 2011-05