NCT02509442

Measure of the Potential Evoked by Electric Stimulation

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 30 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Grade Glioma of Brain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-07-22
• Primary completion: 2027-10-22
• Completion: 2027-11-01
• First posted: 2015-07-28
• Last updated: 2025-09-29

Locations

1 site across 1 country: France