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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02903784
Other study ID # 8674
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2012
Est. completion date September 2016

Study information

Verified date May 2011
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date September 2016
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
1 day
Secondary 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
5 day
Secondary 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
3 month
Secondary Imagery Data Imagery Data 1 day
Secondary Imagery Data Imagery Data 5 day
Secondary Imagery Data Imagery Data 6 month
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