EpilepsyconneXionNCT01738516
Contribution of High Resolution EEG Functional Connectivity Measures to Presurgical Evaluation of Patients With Intractable Epilepsy
A study testing Electroencephalography and Electroencephalography and additional experimental tasks in people with Epilepsy, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Electroencephalography and Electroencephalography and additional experimental tasks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Epilepsy
- Being tested
- Electroencephalography, Electroencephalography and additional experimental tasks
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalographyProcedure or surgery
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.
Electroencephalography and additional experimental tasksProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| epileptic patients | Other | Electroencephalography Receives: Procedure: Electroencephalography |
| Healthy Volunteers | Other | Electroencephalography and additional experimental tasks Receives: Procedure: Electroencephalography and additional experimental tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startFeb 2013
- Primary completionFeb 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Biraben, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738516
- Sponsor's protocol ID
- 2012-A01227-36
- Other IDs
- LOC/12-07
- Acronym
- conneXion
- Status last verified
- May 2023
- First submitted
- 28 Nov 2012
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28910755Kabbara 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.
PubMed 28592794Mheich 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.
PubMed 25583381Hassan 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.
PubMed 27549639Rizkallah 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.
PubMed 30070974Hassan 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.
PubMed 26379232Hassan 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.
PubMed 25115932Hassan 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.
PubMed 26478964
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of High Resolution EEG Functional Connectivity Measures to Presurgical Evaluation of Patients With Intractable Epilepsy
- ClinicalTrials.gov ID
- NCT01738516
- Acronym / sponsor ID
- conneXion / 2012-A01227-36
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Nov 2012 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epileptic patients | Other | Procedure: ElectroencephalographyElectroencephalography |
| Healthy Volunteers | Other | Procedure: Electroencephalography and additional experimental tasksElectroencephalography and additional experimental tasks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| ElectroencephalographyEpileptic 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. | Procedure or surgery | epileptic patients |
| Electroencephalography and additional experimental tasksEpileptic 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. | Procedure or surgery | Healthy Volunteers |
Primary outcome
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.
Time frame: 2 years
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.
1 secondary outcome
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.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Results publication: PubMed 28910755Mheich 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 publication: PubMed 28592794Kabbara 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 publication: PubMed 25583381Mheich 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 publication: PubMed 27549639Hassan 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 publication: PubMed 30070974Rizkallah 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 publication: PubMed 26379232Hassan 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 publication: PubMed 25115932Hassan 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 publication: PubMed 26478964Hassan 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.
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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. This study is not recruiting at the moment.
Arnaud Biraben principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalography and Electroencephalography and additional experimental tasks in people with Epilepsy, run by Rennes University Hospital 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 24 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 years). 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 NCT01738516, which also lists 8 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 24 May 2023.