Measure of the Potential Evoked by Electric Stimulation

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	30 Years - 50 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02509442
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital, Montpellier
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Hugues DUFFAU, Professor
Principal Investigator Affiliation	Department of neurosurgery, Hospital Gui de Chauliac, Montpellier
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Low Grade Glioma of Brain

Additional Details

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.

Arms & Interventions

Arms

Other: Diffusion of direct electric stimulation

Neurosurgery awakened

Interventions

Procedure: - Diffusion of direct electric stimulation

During the neurosurgery awakened consisting in resecting a low-rank infiltrative glioma , the potential evoked further to the direct electric stimulation of the brain will be recorded by electroencephalography and electrocorticography.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Montpellier, France

Status

Recruiting

Address

CHU de Montpellier - Service de neurochirurgie

Montpellier, , 34000

Site Contact

Hugues DUFFAU

[email protected]

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