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NCT Number: NCT02509442

Measure of the Potential Evoked by Electric Stimulation

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.

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Montpellier - Service de neurochirurgie

Montpellier, 34000, France

Location status: Recruiting

Location contact

Hugues DUFFAU

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diffusion of direct electric stimulation

Procedure

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.

Other names: Neurosurgery awakened

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anne VERCHERE

CONTACT

[email protected]

0467330812

BARBAS Sandrine

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • National Development and Research Institutes, Inc.

Registry information

Official study title

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)

Acronym: PE&CE

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2015
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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