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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02304029
Acronym
EPISODIUM
Enrollment
78
Registered
2014-12-01
Start date
2015-03-06
Completion date
2019-11-15
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epileptic Seizures

Keywords

epilepsy, seizures

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

Interventions

DEVICEMRI

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Interest of Sodium MRI in the management of patients for localizing the EZ responsible for seizures that must be removed surgically to cure patients3 yearsThe 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)

Secondary

MeasureTime frameDescription
etablish links between brain ionic changes and brain abnorman electrical activities3yearsComparing 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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMaxime GUYE, MD

Assistance Publique Hopitaux De Marseille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026