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

NCT02603640 | Completed

• 3 other identifiers: 2014-452015-A00298-41RCAPHM14_0109
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (4)

• Determining regions responsible epileptic discharges

  Diffusion MRI

  36 months

• recordings Magnetoencephalography (MEG)

  The number of events per sensor

  36 months

• recordings Electroencephalography (EEG)

  The number of events per sensor

  36 months

• recordings Stereoelectroencephalography (SEEG)

  The number of events per sensor

  36 months

Study Arms (1)

epileptic patient

EXPERIMENTAL

Device: MRI scanning

Interventions

MRI scanning DEVICE

epileptic patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: November 13, 2015
• Study Start: March 18, 2016
• Primary Completion: November 17, 2017
• Study Completion: April 13, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

FR (1)