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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01738516
First received: November 28, 2012
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Epilepsy
Procedure: Electroencephalography
Procedure: Electroencephalography and additional experimental tasks

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Contribution of High Resolution EEG Functional Connectivity Measures to Presurgical Evaluation of Patients With Intractable Epilepsy

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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.


Estimated Enrollment: 40
Study Start Date: February 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
epileptic patients
Electroencephalography
Procedure: Electroencephalography
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.
Healthy Volunteers
Electroencephalography and additional experimental tasks
Procedure: Electroencephalography and additional experimental tasks
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738516

Contacts
Contact: Arnaud Biraben 33-2-9928-4162 arnaud.biraben@chu-rennes.fr

Locations
France
Rennes University Hospital Recruiting
Rennes, Brittany, France, 35033
Contact: Arnaud Biraben    33-2-9928-4162    arnaud.biraben@chu-rennes.fr   
Principal Investigator: Arnaud Biraben         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Arnaud Biraben Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01738516     History of Changes
Other Study ID Numbers: 2012-A01227-36, LOC/12-07
Study First Received: November 28, 2012
Last Updated: October 6, 2014
Health Authority: France :ANSM - Agence Nationale de Sécurité du Médicaments et des produits de santé

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014