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" Virtual Brain "-Based Interpretation of Electrophysiological Signals in Epilepsy (VIBRATIONS)

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI scanning
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Epilepsy patients with planned intracerebral exploration (SEEG)
  • informed patient
  • patient affiliated to French social security

Exclusion Criteria:

  • Patients under 18
  • Pregnant or breastfeeding women
  • Patients deprived of liberty by legal decision
  • Patients not covered by social security
  • Patients who did not sign informed consent
  • patients who cannot undertake MRI exam

Sites / Locations

  • Assistance Publique Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

epileptic patient

Arm Description

Outcomes

Primary Outcome Measures

Determining regions responsible epileptic discharges
Diffusion MRI
recordings Magnetoencephalography (MEG)
The number of events per sensor
recordings Electroencephalography (EEG)
The number of events per sensor
recordings Stereoelectroencephalography (SEEG)
The number of events per sensor

Secondary Outcome Measures

Full Information

First Posted
October 7, 2015
Last Updated
April 13, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02603640
Brief Title
" Virtual Brain "-Based Interpretation of Electrophysiological Signals in Epilepsy
Acronym
VIBRATIONS
Official Title
" Virtual Brain "-Based Interpretation of Electrophysiological Signals in Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 18, 2016 (Actual)
Primary Completion Date
November 17, 2017 (Actual)
Study Completion Date
April 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Epilepsy is a major neurological disorder, affecting of the order of 0.5 to 1% of the population. It is a very invalidating disease, with high impact on quality of life. In a large proportion of cases, medication cannot prevent seizures; surgical removal of the regions responsible for seizures is then the only way to cure patients. However, results crucially depend on the correct delineation of the epileptogenic zone. In this context, computational modeling, under the form of a "virtual brain" is a powerful tool to investigate the impact of different configurations of the sources on the measures, in a well-controlled environment. In this project, the simulate in a biologically realistic way MEG (Magnetoencephalography) and EEG (Electroencephalography) fields produced by different configurations of brain sources, which will differ in terms of spatial and dynamic characteristics will be offered to participants. The research hypothesis is that computational and biophysical models can bring crucial information to clinically interpret the signals measured by MEG and EEG. In particular, the hypothesis can help to efficiently address some complementary questions faced by epileptologists when analyzing electrophysiological data. The strategy will be three-fold: i) Construct a virtual brain models with both dynamic aspects (reproducing both hyperexcitability and hypersynchronisation alterations observed in the epileptic brain) and a realistic geometry based on actual tractography measures performed in patients ii) Explore the parameter space though large-scale simulations of source configurations, using parallel computing implemented on a computer cluster. iii) Confront the results of these simulations to simultaneous recordings of EEG, MEG and intracerebral EEG (stereotactic EEG, stereoelectroencephalography (SEEG)). The models will be tuned on SEEG signals, and tested versus the surface signals in order to validate the ability of the models to represent real MEG and EEG signals. The project constitutes a translational effort from theoretical neuroscience and mathematics towards clinical investigation. A first output of the project will be a database of simulations, which will permit in a given situation to assess the number of configurations that could have given rise to the observed signals in EEG, MEG and SEEG. A second - and major - output of the project will be to give the clinician access to a software platform which will allow for testing possible configurations of hyperexcitable regions in a user-friendly way. Moreover, representative examples will be made available to the community through a website, which will permit its use in future studies aimed at confronting the results of different signal processing methods on the same 'ground truth' data.

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
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
epileptic patient
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MRI scanning
Primary Outcome Measure Information:
Title
Determining regions responsible epileptic discharges
Description
Diffusion MRI
Time Frame
36 months
Title
recordings Magnetoencephalography (MEG)
Description
The number of events per sensor
Time Frame
36 months
Title
recordings Electroencephalography (EEG)
Description
The number of events per sensor
Time Frame
36 months
Title
recordings Stereoelectroencephalography (SEEG)
Description
The number of events per sensor
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Epilepsy patients with planned intracerebral exploration (SEEG) informed patient patient affiliated to French social security Exclusion Criteria: Patients under 18 Pregnant or breastfeeding women Patients deprived of liberty by legal decision Patients not covered by social security Patients who did not sign informed consent patients who cannot undertake MRI exam
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

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" Virtual Brain "-Based Interpretation of Electrophysiological Signals in Epilepsy

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