Usefulness of Sodium MRI in the Presurgical Assessment of Drug-resistant Partial Epilepsy

NCT ID: NCT02304029

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-06
• Study Completion Date: 2019-11-15

Brief Summary

Epilepsy is a common disease affecting 0.5 to 1% of the general population. Epilepsies refractory to drug treatment lead to increased morbidity, mortality and high costs for public health (representing 75% of the costs associated with epilepsy is among the most costly diseases in Neurology). The only curative therapy is surgical removal or disconnection of the epileptogenic network. To do this, a comprehensive presurgical evaluation is essential to accurately define the location of the epileptogenic zone (EZ) and its relationship with the functional areas that must be preserved. This approach requires in some cases intracerebral EEG recordings. This latter technique, expensive and invasive, remains at present, the standard method in the location of the ZE. In this context, the development of non-invasive and inexpensive methods is a priority in the field. Moreover, many fundamental studies have shown changes in ion homeostasis including sodium associated with hyperexcitability related to epilepsy. The investigators team at CEMEREM, CHU Timone, specialized in the development and validation of innovative methods in MRI, has developed an in vivo sodium MRI acquisition and processing of data unique in France, capable of quantifying the intracerebral sodium concentration in three dimensions in a completely non-invasive and non-irradiating manner

Conditions

Epileptic Seizures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

assessment of a innovative MRI

Sodium MRI will be performed at CEMEREM, CHU Timone, the only site with this technique, with a Siemens Verio 3T MRI using a dedicated coil and a sequence already developed locally, in 90 patients with partial drug -resistant epilepsy

Group Type: EXPERIMENTAL

MRI

Intervention Type: DEVICE

Interventions

MRI

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient presenting a drug-resistant partial epilepsy for which an indication is indicated after préchirugical balance assessment.
• Patient not presenting a psychiatric disease chronicles, an demential syndrome,
• Patient not presenting contraindication to the realization of an examination by MRI

Exclusion Criteria

• Patient suffering a not operable shape of partial epilepsy or a generalized epilepsy
• Patient suffering an evolutionary associated serious illness (cancer, autoimmune disease, hepatic insufficiency)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maxime GUYE, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hopitaux De Marseille

Locations

Assistance Publique - Hopitaux de Marseille

Marseille, , France

CHU Montpellier

Montpellier, , France

CHU NICE

Nice, , France

CHU Nimes

Nîmes, , France

Countries

France

Other Identifiers

2014-27

Identifier Type: -

Identifier Source: org_study_id