Measure of the Potential Evoked by Electric Stimulation (PE&CE)
Primary Purpose
Low Grade Glioma of Brain
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diffusion of direct electric stimulation
Sponsored by
About this trial
This is an interventional supportive care trial for Low Grade Glioma of Brain focused on measuring mapping brain functions, Direct electric stimulation (DES), potential evoked
Eligibility Criteria
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
Sites / Locations
- CHU de Montpellier - Service de neurochirurgie
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Diffusion of direct electric stimulation
Arm Description
Neurosurgery awakened
Outcomes
Primary Outcome Measures
Measure of the potential evoked
Measured by electroencephalography and electrocorticography before the beginning of the surgery and before and after the surgical resection
Secondary Outcome Measures
Full Information
NCT ID
NCT02509442
First Posted
April 22, 2015
Last Updated
October 18, 2021
Sponsor
University Hospital, Montpellier
Collaborators
National Development and Research Institutes, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02509442
Brief Title
Measure of the Potential Evoked by Electric Stimulation
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
National Development and Research Institutes, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Grade Glioma of Brain
Keywords
mapping brain functions, Direct electric stimulation (DES), potential evoked
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diffusion of direct electric stimulation
Arm Type
Other
Arm Description
Neurosurgery awakened
Intervention Type
Procedure
Intervention Name(s)
Diffusion of direct electric stimulation
Other Intervention Name(s)
Neurosurgery awakened
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure of the potential evoked
Description
Measured by electroencephalography and electrocorticography before the beginning of the surgery and before and after the surgical resection
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugues DUFFAU, Professor
Organizational Affiliation
Department of neurosurgery, Hospital Gui de Chauliac, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Montpellier - Service de neurochirurgie
City
Montpellier
ZIP/Postal Code
34000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
9210055
Citation
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.
Results Reference
background
PubMed Identifier
22127300
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.
Results Reference
background
PubMed Identifier
11150363
Citation
DeAngelis LM. Brain tumors. N Engl J Med. 2001 Jan 11;344(2):114-23. doi: 10.1056/NEJM200101113440207. No abstract available.
Results Reference
background
PubMed Identifier
16033690
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.
Results Reference
background
PubMed Identifier
11834604
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.
Results Reference
background
PubMed Identifier
15897509
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.
Results Reference
background
PubMed Identifier
10632114
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.
Results Reference
background
PubMed Identifier
15035270
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.
Results Reference
background
PubMed Identifier
25180306
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.
Results Reference
background
PubMed Identifier
17046857
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.
Results Reference
background
PubMed Identifier
15269116
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.
Results Reference
background
PubMed Identifier
20121442
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.
Results Reference
background
PubMed Identifier
14980531
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.
Results Reference
background
PubMed Identifier
12464515
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.
Results Reference
background
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Measure of the Potential Evoked by Electric Stimulation
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