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

NCT02304029 | Completed DMC

• 1 other identifier: 2014-27
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 4

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

Keywords

epilepsy; seizures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• etablish links between brain ionic changes and brain abnorman electrical activities

  3years

Study Arms (1)

assessment of a innovative MRI

EXPERIMENTAL

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

Device: MRI

Interventions

MRI DEVICE

assessment of a innovative MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (4)

Assistance Publique - Hopitaux de Marseille

Marseille, 13005, France

Location

CHU Montpellier

Montpellier, France

Location

CHU NICE

Nice, France

Location

CHU Nimes

Nîmes, France

Location

Related Publications (1)

• Wirsich J, Perry A, Ridley B, Proix T, Golos M, Benar C, Ranjeva JP, Bartolomei F, Breakspear M, Jirsa V, Guye M. Whole-brain analytic measures of network communication reveal increased structure-function correlation in right temporal lobe epilepsy. Neuroimage Clin. 2016 May 19;11:707-718. doi: 10.1016/j.nicl.2016.05.010. eCollection 2016.

  PMID: 27330970 RESULT

MeSH Terms

Conditions

Seizures; Epilepsy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Study Officials

• Maxime GUYE, MD

  Assistance Publique Hopitaux De Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: December 1, 2014
• Study Start: March 6, 2015
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: May 8, 2026

Record last verified: 2022-10

Locations

FR (4)