NCT02509442

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jul 2015Nov 2027

First Submitted

Initial submission to the registry

April 22, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 22, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
12.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2027

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

12.3 years

First QC Date

April 22, 2015

Last Update Submit

September 25, 2025

Conditions

Low Grade Glioma of Brain

Keywords

mapping brain functionsDirect electric stimulation (DES)potential evoked

Outcome Measures

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

    2 months

Study Arms (1)

Diffusion of direct electric stimulation

OTHER

Neurosurgery awakened

Procedure: Diffusion of direct electric stimulation

Interventions

Diffusion of direct electric stimulationPROCEDURE

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.

Also known as: Neurosurgery awakened
Diffusion of direct electric stimulation

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • Membership or beneficiary of a national insurance scheme

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Montpellier - Service de neurochirurgie

Montpellier, 34000, France

RECRUITING

Related Publications (16)

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    PMID: 2111370BACKGROUND

  • Turpin C, Rossel O, Schlosser-Perrin F, Ng S, Matsumoto R, Mandonnet E, Duffau H, Bonnetblanc F. Shapes of direct cortical responses vs. short-range axono-cortical evoked potentials: The effects of direct electrical stimulation applied to the human brain. Clin Neurophysiol. 2025 Jan;169:91-99. doi: 10.1016/j.clinph.2024.10.016. Epub 2024 Nov 8.

    PMID: 39578190BACKGROUND

  • Berger MS, Rostomily RC. Low grade gliomas: functional mapping resection strategies, extent of resection, and outcome. J Neurooncol. 1997 Aug;34(1):85-101. doi: 10.1023/a:1005715405413.

    PMID: 9210055BACKGROUND

  • Borchers S, Himmelbach M, Logothetis N, Karnath HO. Direct electrical stimulation of human cortex - the gold standard for mapping brain functions? Nat Rev Neurosci. 2011 Nov 30;13(1):63-70. doi: 10.1038/nrn3140.

    PMID: 22127300BACKGROUND

  • DeAngelis LM. Brain tumors. N Engl J Med. 2001 Jan 11;344(2):114-23. doi: 10.1056/NEJM200101113440207. No abstract available.

    PMID: 11150363BACKGROUND

  • Duffau H. Lessons from brain mapping in surgery for low-grade glioma: insights into associations between tumour and brain plasticity. Lancet Neurol. 2005 Aug;4(8):476-86. doi: 10.1016/S1474-4422(05)70140-X.

    PMID: 16033690BACKGROUND

  • Duffau H, Capelle L, Sichez N, Denvil D, Lopes M, Sichez JP, Bitar A, Fohanno D. Intraoperative mapping of the subcortical language pathways using direct stimulations. An anatomo-functional study. Brain. 2002 Jan;125(Pt 1):199-214. doi: 10.1093/brain/awf016.

    PMID: 11834604BACKGROUND

  • 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.

    PMID: 15897509BACKGROUND

  • Duffau H, Sichez JP, Lehericy S. Intraoperative unmasking of brain redundant motor sites during resection of a precentral angioma: evidence using direct cortical stimulation. Ann Neurol. 2000 Jan;47(1):132-5.

    PMID: 10632114BACKGROUND

  • Keles GE, Lundin DA, Lamborn KR, Chang EF, Ojemann G, Berger MS. Intraoperative subcortical stimulation mapping for hemispherical perirolandic gliomas located within or adjacent to the descending motor pathways: evaluation of morbidity and assessment of functional outcome in 294 patients. J Neurosurg. 2004 Mar;100(3):369-75. doi: 10.3171/jns.2004.100.3.0369.

    PMID: 15035270BACKGROUND

  • 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.

    PMID: 25180306BACKGROUND

  • Matsumoto R, Nair DR, LaPresto E, Bingaman W, Shibasaki H, Luders HO. Functional connectivity in human cortical motor system: a cortico-cortical evoked potential study. Brain. 2007 Jan;130(Pt 1):181-97. doi: 10.1093/brain/awl257. Epub 2006 Oct 17.

    PMID: 17046857BACKGROUND

  • Matsumoto R, Nair DR, LaPresto E, Najm I, Bingaman W, Shibasaki H, Luders HO. Functional connectivity in the human language system: a cortico-cortical evoked potential study. Brain. 2004 Oct;127(Pt 10):2316-30. doi: 10.1093/brain/awh246. Epub 2004 Jul 21.

    PMID: 15269116BACKGROUND

  • Szelenyi A, Bello L, Duffau H, Fava E, Feigl GC, Galanda M, Neuloh G, Signorelli F, Sala F; Workgroup for Intraoperative Management in Low-Grade Glioma Surgery within the European Low-Grade Glioma Network. Intraoperative electrical stimulation in awake craniotomy: methodological aspects of current practice. Neurosurg Focus. 2010 Feb;28(2):E7. doi: 10.3171/2009.12.FOCUS09237.

    PMID: 20121442BACKGROUND

  • Taphoorn MJ, Klein M. Cognitive deficits in adult patients with brain tumours. Lancet Neurol. 2004 Mar;3(3):159-68. doi: 10.1016/S1474-4422(04)00680-5.

    PMID: 14980531BACKGROUND

  • 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.

    PMID: 12464515BACKGROUND

Study Officials

  • Hugues DUFFAU, Professor

    Department of neurosurgery, Hospital Gui de Chauliac, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

BARBAS Sandrine

CONTACT

s-barbas@chu-montpellier.fr

Anne VERCHERE

CONTACT

0467330812a-verchere@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2015

First Posted

July 28, 2015

Study Start

July 22, 2015

Primary Completion (Estimated)

October 22, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

September 29, 2025

Record last verified: 2025-09

Locations

FR(1)