Measure of the Potential Evoked by Electric Stimulation

Low Grade Glioma of Brain Clinical Trial

— PE&CE  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02509442
• Other study ID #: 9530
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2015
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: BARBAS Sandrine
• Email: s-barbas[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2025
• Est. primary completion date: November 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Low Grade Glioma of Brain

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Montpellier - Service de neurochirurgie	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	National Development and Research Institutes, Inc.

Country where clinical trial is conducted

France, 

References & Publications (14)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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