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Contribution of High Resolution EEG Functional Connectivity Measures to Presurgical Evaluation of Patients With Intractable Epilepsy (conneXion)

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electroencephalography
Electroencephalography and additional experimental tasks
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria Patients:

  • 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.

Inclusion Criteria Healthy Volunteers:

  • Being French native speaker,
  • Being more than 18 years old,
  • Being right-handed.

Exclusion Criteria Patients:

  • 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.

Exclusion Criteria Healthy Volunteers:

  • 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.

Sites / Locations

  • Rennes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

epileptic patients

Healthy Volunteers

Arm Description

Electroencephalography

Electroencephalography and additional experimental tasks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Our secondary objectives are: The application of linear, non-linear and phase synchronization methods in digital signal processing on broadband band analysis or on band-filtered EEG signals acquired during HR-EEG explorations of patients with epilepsy, The evaluation of the performance of these methods by comparing the resulting connectivity graphs with those expected in healthy subjects (controls), The application of the methods offering the best performances to data acquired in patients.

Full Information

First Posted
November 28, 2012
Last Updated
May 22, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01738516
Brief Title
Contribution of High Resolution EEG Functional Connectivity Measures to Presurgical Evaluation of Patients With Intractable Epilepsy
Acronym
conneXion
Official Title
Contribution of High Resolution EEG Functional Connectivity Measures to Presurgical Evaluation of Patients With Intractable Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
epileptic patients
Arm Type
Other
Arm Description
Electroencephalography
Arm Title
Healthy Volunteers
Arm Type
Other
Arm Description
Electroencephalography and additional experimental tasks
Intervention Type
Procedure
Intervention Name(s)
Electroencephalography
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Electroencephalography and additional experimental tasks
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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.
Description
Our secondary objectives are: The application of linear, non-linear and phase synchronization methods in digital signal processing on broadband band analysis or on band-filtered EEG signals acquired during HR-EEG explorations of patients with epilepsy, The evaluation of the performance of these methods by comparing the resulting connectivity graphs with those expected in healthy subjects (controls), The application of the methods offering the best performances to data acquired in patients.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Patients: 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. Inclusion Criteria Healthy Volunteers: Being French native speaker, Being more than 18 years old, Being right-handed. Exclusion Criteria Patients: 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. Exclusion Criteria Healthy Volunteers: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Biraben
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes
State/Province
Brittany
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28910755
Citation
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.
Results Reference
result
PubMed Identifier
28592794
Citation
Kabbara 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.
Results Reference
result
PubMed Identifier
25583381
Citation
Mheich 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.
Results Reference
result
PubMed Identifier
27549639
Citation
Hassan 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.
Results Reference
result
PubMed Identifier
30070974
Citation
Rizkallah 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.
Results Reference
result
PubMed Identifier
26379232
Citation
Hassan 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.
Results Reference
result
PubMed Identifier
25115932
Citation
Hassan 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.
Results Reference
result
PubMed Identifier
26478964
Citation
Hassan 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.
Results Reference
result

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Contribution of High Resolution EEG Functional Connectivity Measures to Presurgical Evaluation of Patients With Intractable Epilepsy

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