NCT Number: NCT02304029
Usefulness of Sodium MRI in the Presurgical Assessment of Drug-resistant Partial Epilepsy
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
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Assistance Publique - Hopitaux de Marseille, Marseille, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Primary outcomes
-
Interest of Sodium MRI in the management of patients for localizing the EZ responsible for seizures that must be removed surgically to cure patients
Time frame: 3 years
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)
Secondary outcomes
-
etablish links between brain ionic changes and brain abnorman electrical activities
Time frame: 3years
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
Sponsors and collaborators
Lead sponsor
Assistance Publique Hopitaux De Marseille
Other
Registry information
Acronym: EPISODIUM
Important dates
- Study start
- 2015
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Dec 1, 2014
- Registry last updated
- May 8, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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