Contribution of High Resolution EEG Functional Connectivity Measures to Presurgical Evaluation of Patients With Intractable Epilepsy
conneXion
2 other identifiers
interventional
44
1 country
1
Brief Summary
Electroencephalography (EEG) with very high spatial resolution (HR-EEG, 256 electrodes) allow for better analysis of local and global activity of the cerebral cortex, as compared with conventional EEG. Since January 2012, the Neurology Department of CHU Rennes is the first clinical service in France equipped with such a system. Applied to HR-EEG recordings, brain connectivity methods are likely to provide essential information (in the form of "connectivity graphs") on cortical networks, either dysfunctional or not, involved in the generation of interictal paroxysms (like spikes or spike-waves) and during seizures. So far, many methods have been proposed (see for a review: Wendling et al., 2009; Wendling et al., 2010). However, since each method is highly sensitive to the type of model that is assumed for the underlying relationship between distinct brain regions (Ansari-Asl et al., 2006), none of them has yet demonstrated its effectiveness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2012
CompletedFirst Posted
Study publicly available on registry
November 30, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedMay 24, 2023
May 1, 2023
3 years
November 28, 2012
May 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The quality of matching between i) the graphs produced by the evaluated connectivity method(s) applied to the HR-EEG and ii) the results of the visual analysis typically performed by an expert on the standard EEG recorded during intercritical phase.
Main objective :To determine which functional connectivity estimation method(s) show(s) best performance(s) for the identification of epileptogenic networks from the HR-EEG recording performed in epileptic patients.
2 years
Secondary Outcomes (1)
The quality of matching between i) the connectivity graphs obtained from control subjects performing a well defined cognitive task to ii) data from the literature on networks activated and sustaining these cognitive processes.
2 years
Study Arms (2)
epileptic patients
OTHERElectroencephalography
Healthy Volunteers
OTHERElectroencephalography and additional experimental tasks
Interventions
Epileptic patients, as in healthy volunteers will be offered a review of EEG recording equipment resting on EEG-HR 256-channel EGI © in operation since January 2012 in the Van Gogh Service Unit of Neurology Rennes University Hospital (hospital Pontchaillou). The EEG is a routine now included in the Phase I report some epileptic patients during presurgical investigation. Patients to be included in this research protocol pass all review on the new device EEG-HR 256 channels. In addition to the rest condition, shared by both groups of participants, the healthy control subjects participate in two additional experimental tasks to be performed during recording. A picture naming task and a task of spelling words represented by these images.
Epileptic patients, as in healthy volunteers will be offered a review of EEG recording equipment resting on EEG-HR 256-channel EGI © in operation since January 2012 in the Van Gogh Service Unit of Neurology Rennes University Hospital (hospital Pontchaillou). The EEG is a routine now included in the Phase I report some epileptic patients during presurgical investigation. Patients to be included in this research protocol pass all review on the new device EEG-HR 256 channels. In addition to the rest condition, shared by both groups of participants, the healthy control subjects participate in two additional experimental tasks to be performed during recording. A picture naming task and a task of spelling words represented by these images.
Eligibility Criteria
You may qualify if:
- Being more than 18 years old,
- Having a chronic partial epilepsy resistant to medical treatments well administered and well followed in the course of pre-surgical assessment.
- Being French native speaker,
- Being more than 18 years old,
- Being right-handed.
You may not qualify if:
- All patients for whom a preoperative surgical exam is not suitable,
- Any patient with psychiatric disease or intellectual disorder such that informed consent could not be obtained,
- Any patient with no abnormal EEG during intercritical phases,
- All patients presenting psychiatric, neuropsychological or developmental difficulties in addition to epilepsy,
- Adult persons subject to legal protection (judicial protection, temporary guardianship/guardianship, administrative supervision), persons deprived of their liberty and pregnant or lactating women.
- The presence of any psychiatric, neuropsychological, and developmental disorder,
- Any uncorrected visual impairment,
- Any trouble or delay in learning to read / speak or write French,
- Being fully bilingual or multilingual
- Medication, treatment and / or substances that may alter or modify brain functions,
- Adult persons subject to legal protection (judicial protection, temporary guardianship/guardianship, administrative supervision), persons deprived of their liberty and pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rennes University Hospital
Rennes, Brittany Region, 35033, France
Related Publications (8)
Mheich A, Hassan M, Khalil M, Gripon V, Dufor O, Wendling F. SimiNet: A Novel Method for Quantifying Brain Network Similarity. IEEE Trans Pattern Anal Mach Intell. 2018 Sep;40(9):2238-2249. doi: 10.1109/TPAMI.2017.2750160. Epub 2017 Sep 8.
PMID: 28910755RESULTKabbara A, El Falou W, Khalil M, Wendling F, Hassan M. The dynamic functional core network of the human brain at rest. Sci Rep. 2017 Jun 7;7(1):2936. doi: 10.1038/s41598-017-03420-6.
PMID: 28592794RESULTMheich A, Hassan M, Khalil M, Berrou C, Wendling F. A new algorithm for spatiotemporal analysis of brain functional connectivity. J Neurosci Methods. 2015 Mar 15;242:77-81. doi: 10.1016/j.jneumeth.2015.01.002. Epub 2015 Jan 10.
PMID: 25583381RESULTHassan M, Merlet I, Mheich A, Kabbara A, Biraben A, Nica A, Wendling F. Identification of Interictal Epileptic Networks from Dense-EEG. Brain Topogr. 2017 Jan;30(1):60-76. doi: 10.1007/s10548-016-0517-z. Epub 2016 Aug 22.
PMID: 27549639RESULTRizkallah J, Benquet P, Kabbara A, Dufor O, Wendling F, Hassan M. Dynamic reshaping of functional brain networks during visual object recognition. J Neural Eng. 2018 Oct;15(5):056022. doi: 10.1088/1741-2552/aad7b1. Epub 2018 Aug 2.
PMID: 30070974RESULTHassan M, Shamas M, Khalil M, El Falou W, Wendling F. EEGNET: An Open Source Tool for Analyzing and Visualizing M/EEG Connectome. PLoS One. 2015 Sep 17;10(9):e0138297. doi: 10.1371/journal.pone.0138297. eCollection 2015.
PMID: 26379232RESULTHassan M, Dufor O, Merlet I, Berrou C, Wendling F. EEG source connectivity analysis: from dense array recordings to brain networks. PLoS One. 2014 Aug 12;9(8):e105041. doi: 10.1371/journal.pone.0105041. eCollection 2014.
PMID: 25115932RESULTHassan M, Benquet P, Biraben A, Berrou C, Dufor O, Wendling F. Dynamic reorganization of functional brain networks during picture naming. Cortex. 2015 Dec;73:276-88. doi: 10.1016/j.cortex.2015.08.019. Epub 2015 Sep 28.
PMID: 26478964RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arnaud Biraben
Rennes University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2012
First Posted
November 30, 2012
Study Start
February 1, 2013
Primary Completion
February 1, 2016
Study Completion
August 1, 2016
Last Updated
May 24, 2023
Record last verified: 2023-05