Clinical trial NCT02509442: Measure of the Potential Evoked by Electric Stimulation
Official title: Pilot Study: Measure of the Potential Evoked With Electroencephalography and Electrocorticography by Electric Stimulation of the Brain During the Neurosurgery Awakened of the Infiltrative Glioma of Low Grade (OMS Type II)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Grade Glioma of Brain
Keywords: mapping brain functions
Direct electric stimulation (DES)
potential evoked
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: National Development and Research Institutes, Inc.
First posted: 2015-07-28
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is about an experimental biomedical monocentric search concerning twelves patients presenting a infiltrative glioma of low rank OMS type II and realizing a surgery awakened on the site of the CHU of Montpellier.

The objective of this search is to understand exactly how the electric impulses, delivered by the neurosurgeon to make a functional mapping of the brain during the surgery awakened by tumors infiltrates of low rank, propagate in this one and to identify the nervous networks inhibited by these electric impulses.

Having verified the eligibility of the patients and having obtained their consent, they will be included in the study. Before the beginning of the surgery, the electroencephalography activity of the brain of every patient will be recorded. Before and after the surgical resection, the electrocorticography activity will be recorded.

The collected data will then be analyzed, after the operation. Analyses will try to identify what we call potential evoked by the stimulation and which are small electric waves which appear after the electric stimulation was delivered.

Detailed description: All the surgical operations will be realized by Professor Hugues DUFFAU. The DEMAR-INRIA team will assure the collection and the data processing electrophysiological, the management of the data and the methodological follow-up, as well as the writing of the report and the distribution of the results.

The quality assurance will be assured by a "minimal" monitoring by an assistant of clinical research for the department of the research and the innovation, to Montpellier, which will verify principally the consents.

The electrophysiological data digitized will be stored in the form of computer files via PowerLab.

All the analyses of treatment of signals required to highlight the potential evoked will be realized with the software Matlab.

Eligibility criteria: Inclusion Criteria:

* Patient carrier of a low-rank infiltrative glioma (OMS Type II) and presenting the indications to benefit from a surgical care in condition awakened for the first time.
* Patient capable of understanding the nature, the purpose and the methodology of the research.
* Having signed an informed consent writes before the inclusion in the research.
* Membership or beneficiary of a national insurance scheme

Exclusion Criteria:

* Systematic pathology with neurological appearance
* Psychiatric disorders
* History of psychotic disorders
* History of cranial trauma serious (according to the classification), previous or evolutionary other neurological pathology
* Major protected by the law (supervision or guardianship)
* Loss of liberty by court or administrative order

Primary outcomes:
measure: Measure of the potential evoked
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier - Service de neurochirurgie
Study officials:
affiliation: Department of neurosurgery, Hospital Gui de Chauliac, Montpellier
name: Hugues DUFFAU, Professor
role: PRINCIPAL_INVESTIGATOR
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