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

May 22, 2023 updated by: Rennes University Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Brittany
      • Rennes, Brittany, France, 35033
        • Rennes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Arnaud Biraben, Rennes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

November 28, 2012

First Submitted That Met QC Criteria

November 28, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A01227-36
  • LOC/12-07 (Other Identifier: Rennes University Hospital (Direction of Clinical Research))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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