Measure of the Potential Evoked by Electric Stimulation

NCT ID: NCT02509442

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-22

Study Completion Date

2027-11-30

Brief Summary

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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

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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

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Low Grade Glioma of Brain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Diffusion of direct electric stimulation

Neurosurgery awakened

Group Type OTHER

Diffusion of direct electric stimulation

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Neurosurgery awakened

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Development and Research Institutes, Inc.

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hugues DUFFAU, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of neurosurgery, Hospital Gui de Chauliac, Montpellier

Locations

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CHU de Montpellier - Service de neurochirurgie

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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BARBAS Sandrine

Role: CONTACT

Anne VERCHERE

Role: CONTACT

0467330812

Facility Contacts

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Hugues DUFFAU

Role: primary

References

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Duffau H, Lopes M, Arthuis F, Bitar A, Sichez JP, Van Effenterre R, Capelle L. Contribution of intraoperative electrical stimulations in surgery of low grade gliomas: a comparative study between two series without (1985-96) and with (1996-2003) functional mapping in the same institution. J Neurol Neurosurg Psychiatry. 2005 Jun;76(6):845-51. doi: 10.1136/jnnp.2004.048520.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Keller CJ, Honey CJ, Megevand P, Entz L, Ulbert I, Mehta AD. Mapping human brain networks with cortico-cortical evoked potentials. Philos Trans R Soc Lond B Biol Sci. 2014 Oct 5;369(1653):20130528. doi: 10.1098/rstb.2013.0528.

Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 17046857 (View on PubMed)

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Reference Type BACKGROUND
PMID: 15269116 (View on PubMed)

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Walker DG, Kaye AH. Low grade glial neoplasms. J Clin Neurosci. 2003 Jan;10(1):1-13. doi: 10.1016/s0967-5868(02)00261-8. No abstract available.

Reference Type BACKGROUND
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Other Identifiers

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9530

Identifier Type: -

Identifier Source: org_study_id

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