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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Measure of the potential evoked
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Diffusion of direct electric stimulation
Neurosurgery awakened
Intervention: Diffusion of direct electric stimulation (Procedure)
Outcomes
Primary Outcomes
Measure of the potential evoked
Time Frame: 2 months
Measured by electroencephalography and electrocorticography before the beginning of the surgery and before and after the surgical resection
Secondary Outcomes
No secondary outcomes reported