Low Grade Glioma of BrainPE&CENCT02509442
Measure of the Potential Evoked by Electric Stimulation
A study testing Diffusion of direct electric stimulation in people with Low Grade Glioma of Brain, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Low Grade Glioma of Brain
- What is being tested?
- Diffusion of direct electric stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2015to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
BARBAS Sandrine contact
France1 site, 1 recruiting
- Recruiting
CHU de Montpellier - Service de neurochirurgie
Montpellier, 34000
Hugues DUFFAU, h-duffau@chu-montpellier.fr
About this study
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)
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.
Read more
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.
Read the 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.
- Conditions
- Low Grade Glioma of Brain
- Being tested
- Diffusion of direct electric stimulation
- Keywords
- mapping brain functions, Direct electric stimulation (DES), potential evoked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion of direct electric stimulationProcedure or surgery
Also called Neurosurgery awakened
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.
| Study group | Role | What they receive |
|---|---|---|
| Diffusion of direct electric stimulation | Other | Neurosurgery awakened Receives: Procedure: Diffusion of direct electric stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the potential evoked
Measured by electroencephalography and electrocorticography before the beginning of the surgery and before and after the surgical resection
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study start22 Jul 2015
- Primary completion22 Oct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Low Grade Glioma of BrainStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- National Development and Research Institutes, Inc.
- Responsible party
- Sponsor
- Investigators
- Hugues DUFFAU, Professor, Principal investigator, Department of neurosurgery, Hospital Gui de Chauliac, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509442
- Sponsor's protocol ID
- 9530
- Acronym
- PE&CE
- Status last verified
- Sep 2025
- First submitted
- 22 Apr 2015
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosenwald AG, Krag SS. Lec9 CHO glycosylation mutants are defective in the synthesis of dolichol. J Lipid Res. 1990 Mar;31(3):523-33.
PubMed 2111370Berger 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.
PubMed 9210055Borchers 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.
PubMed 22127300DeAngelis LM. Brain tumors. N Engl J Med. 2001 Jan 11;344(2):114-23. doi: 10.1056/NEJM200101113440207. No abstract available.
PubMed 11150363Duffau 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.
PubMed 16033690Duffau 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.
PubMed 11834604Duffau 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.
PubMed 15897509Duffau 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.
PubMed 10632114Keles 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.
PubMed 15035270Keller 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.
PubMed 25180306Matsumoto 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.
PubMed 17046857Matsumoto 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.
PubMed 15269116Szelenyi 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.
PubMed 20121442Taphoorn 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.
PubMed 14980531Walker 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.
PubMed 12464515
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02509442
- Acronym / sponsor ID
- PE&CE / 9530
- Conditions
- Low Grade Glioma of Brain
- Keywords
- mapping brain functions, Direct electric stimulation (DES), potential evoked
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- National Development and Research Institutes, Inc.
- Study start
- 22 Jul 2015 (actual)
- Primary completion
- 22 Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 28 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diffusion of direct electric stimulation | Other | Procedure: Diffusion of direct electric stimulationNeurosurgery awakened |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffusion of direct electric stimulationAlso: Neurosurgery awakenedDuring 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. | Procedure or surgery | Diffusion of direct electric stimulation |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Background: PubMed 2111370Rosenwald AG, Krag SS. Lec9 CHO glycosylation mutants are defective in the synthesis of dolichol. J Lipid Res. 1990 Mar;31(3):523-33.
- Background: PubMed 9210055Berger 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.
- Background: PubMed 22127300Borchers 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.
- Background: PubMed 11150363DeAngelis LM. Brain tumors. N Engl J Med. 2001 Jan 11;344(2):114-23. doi: 10.1056/NEJM200101113440207. No abstract available.
- Background: PubMed 16033690Duffau 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.
- Background: PubMed 11834604Duffau 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.
- Background: PubMed 15897509Duffau 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.
- Background: PubMed 10632114Duffau 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.
- Background: PubMed 15035270Keles 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.
- Background: PubMed 25180306Keller 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.
- Background: PubMed 17046857Matsumoto 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.
- Background: PubMed 15269116Matsumoto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BARBAS Sandrine contact
Hugues DUFFAU, Professor principal investigator
Department of neurosurgery, Hospital Gui de Chauliac, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion of direct electric stimulation in people with Low Grade Glioma of Brain, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BARBAS Sandrine (s-barbas@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the potential evoked (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02509442, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.