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

Epileptic Seizures Clinical Trial

— EPISODIUM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304029
• Other study ID #: 2014-27
• Status: Completed
• Phase: N/A
• Start date: March 6, 2015
• Est. completion date: November 15, 2019

Study information

• Verified date: October 2022
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: November 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Epileptic Seizures
• Seizures

Intervention

Device:
• MRI

Locations

Country	Name	City	State
France	Assistance Publique - Hopitaux de Marseille	Marseille
France	CHU Montpellier	Montpellier
France	CHU NICE	Nice
France	CHU Nimes	Nimes

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	Interest of Sodium MRI in the management of patients for localizing the EZ responsible for seizures that must be removed surgically to cure patients	The location of significant abnormal sodium concentrations will be compared to the location of surgical excision and faced with post-surgical results. The number of concordant and discordant locations (locations of sodium concentration abnormalities/ surgical cavity) It will be allowed the sensitivity, specificity, positive predictive value and negative predictive value of our technique ( patients free of seizures compare non-free patients crises postoperatively)	3 years
Secondary	etablish links between brain ionic changes and brain abnorman electrical activities	Comparing the location of sodium abnormalities with the location of electrical abnormalities recorded in surface (EEG) or depth (SEEG) will allow us to establish links between ionic changes and abnormal electrical activity	3years