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

Epilepsy Clinical Trial

— VIBRATIONS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603640
• Other study ID #: 2014-45
• Secondary ID: 2015-A00298-41RC
• Status: Completed
• Phase: N/A
• Start date: March 18, 2016
• Est. completion date: April 13, 2023

Study information

• Verified date: April 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 13, 2023
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• MRI scanning

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining regions responsible epileptic discharges	Diffusion MRI	36 months
Primary	recordings Magnetoencephalography (MEG)	The number of events per sensor	36 months
Primary	recordings Electroencephalography (EEG)	The number of events per sensor	36 months
Primary	recordings Stereoelectroencephalography (SEEG)	The number of events per sensor	36 months