Measure of the Potential Evoked by Electric Stimulation
ConditionLow Grade Glioma of Brain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-50
SponsorUniversity Hospital, Montpellier
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Diffusion of direct electric stimulation
Procedure/SurgeryDuring 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.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Diffusion of direct electric stimulationOther 1 intervention
Trial outcomes
Primary outcomes
1
Measure of the potential evoked
Measured by electroencephalography and electrocorticography before the beginning of the surgery and before and after the surgical resection
Time frame
2 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Montpellier
Lead sponsor
National Development and Research Institutes, Inc.
Collaborator
Source ClinicalTrials.gov