Measure of the Potential Evoked by Electric Stimulation

Not Applicable

Recruiting

• Conditions: Low Grade Glioma of Brain
• Interventions: Procedure: Diffusion of direct electric stimulation

• Registration Number: NCT02509442
• Lead Sponsor: University Hospital, Montpellier

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 Timeline

• Study First Submitted: 2015-04-22
• Study Start: 2015-07-22
• Study First Submitted QC: 2015-07-23
• Study First Posted: 2015-07-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Primary Completion: 2025-11-22
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diffusion of direct electric stimulation	Diffusion of direct electric stimulation	Neurosurgery awakened

Primary Outcome Measures

Name	Time	Method
Measure of the potential evoked	2 months	Measured by electroencephalography and electrocorticography before the beginning of the surgery and before and after the surgical resection

Trial Locations

Locations (1)

CHU de Montpellier - Service de neurochirurgie; 🇫🇷 Montpellier, France