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

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ClinicalTrials.gov Identifier: NCT01738516
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Tracking Information
First Submitted Date  ICMJE November 28, 2012
First Posted Date  ICMJE November 30, 2012
Last Update Posted Date October 5, 2016
Study Start Date  ICMJE February 2013
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2012)
The adequacy of i)The graphs produced by the retained connectivity method(s) applied to the HR-EEG and ii) the results of the visual analysis typically performed by an expert (a neurologist) on the standard EEG recorded during intericritical phase. [ Time Frame: 2 years ]
Main objective :Determination of the functional connectivity estimation method(s) with the best performance(s) for the identification of epileptogenic networks from the HR-EEG in epileptic patients.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
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 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2012)
The adequacy of 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 ]
Our secondary objectives are:
  • The application of linear, non-linear and phase synchronization methods in digital signal processing over a wide frequency band analysis or a band-filtered analysis. Signals will be acquired during an EEG examination with high spatial resolution (HR-EEG),
  • Evaluating 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Contribution of High Resolution EEG Functional Connectivity Measures to Presurgical Evaluation of Patients With Intractable Epilepsy
Official Title  ICMJE Contribution of High Resolution EEG Functional Connectivity Measures to Presurgical Evaluation of Patients With Intractable Epilepsy
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • epileptic patients
    Electroencephalography
    Intervention: Procedure: Electroencephalography
  • Healthy Volunteers
    Electroencephalography and additional experimental tasks
    Intervention: Procedure: Electroencephalography and additional experimental tasks
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2016)
44
Original Estimated Enrollment  ICMJE
 (submitted: November 28, 2012)
40
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01738516
Other Study ID Numbers  ICMJE 2012-A01227-36
LOC/12-07 ( Other Identifier: Rennes University Hospital (Direction of Clinical Research) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rennes University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rennes University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arnaud Biraben Rennes University Hospital
PRS Account Rennes University Hospital
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP