Usefulness of Sodium MRI in the Presurgical Assessment of Drug-resistant Partial Epilepsy (EPISODIUM)
Primary Purpose
Epileptic Seizures
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Epileptic Seizures focused on measuring epilepsy, seizures
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)
Sites / Locations
- Assistance Publique - Hopitaux de Marseille
- CHU Montpellier
- CHU NICE
- CHU Nimes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
assessment of a innovative MRI
Arm Description
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
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02304029
First Posted
November 20, 2014
Last Updated
October 26, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02304029
Brief Title
Usefulness of Sodium MRI in the Presurgical Assessment of Drug-resistant Partial Epilepsy
Acronym
EPISODIUM
Official Title
Usefulness of Sodium MRI in the Presurgical Assessment of Drug-resistant Partial Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 6, 2015 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epileptic Seizures
Keywords
epilepsy, seizures
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
assessment of a innovative MRI
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
Interest of Sodium MRI in the management of patients for localizing the EZ responsible for seizures that must be removed surgically to cure patients
Description
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)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
etablish links between brain ionic changes and brain abnorman electrical activities
Description
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
Time Frame
3years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maxime GUYE, MD
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique - Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
CHU Montpellier
City
Montpellier
Country
France
Facility Name
CHU NICE
City
Nice
Country
France
Facility Name
CHU Nimes
City
Nimes
Country
France
12. IPD Sharing Statement
Learn more about this trial
Usefulness of Sodium MRI in the Presurgical Assessment of Drug-resistant Partial Epilepsy
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