Epileptic SeizuresEPISODIUMNCT02304029
Usefulness of Sodium MRI in the Presurgical Assessment of Drug-resistant Partial Epilepsy
A study testing MRI in people with Epileptic Seizures, run by Assistance Publique Hopitaux De Marseille at 4 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epileptic Seizures
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 4 sitesFrance
- Study dates
- 6 Mar 2015to 15 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
France4 sites
Assistance Publique - Hopitaux de Marseille
Marseille, 13005
CHU Montpellier
Montpellier
CHU NICE
Nice
CHU Nimes
Nîmes
About this study
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
- Being tested
- MRI
- Keywords
- epilepsy, seizures
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 years
Secondary outcomes (1)
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
Measured: 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study start6 Mar 2015
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epileptic SeizuresStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime GUYE, MD, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304029
- Sponsor's protocol ID
- 2014-27
- Acronym
- EPISODIUM
- Status last verified
- Oct 2022
- First submitted
- 20 Nov 2014
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27330970
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Sodium MRI in the Presurgical Assessment of Drug-resistant Partial Epilepsy
- ClinicalTrials.gov ID
- NCT02304029
- Acronym / sponsor ID
- EPISODIUM / 2014-27
- Conditions
- Epileptic Seizures
- Keywords
- epilepsy, seizures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 6 Mar 2015 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 1 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assessment of a innovative MRI | Experimental | Device: MRISodium 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI | Device | assessment of a innovative MRI |
Primary outcome
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)
1 secondary outcome
etablish links between brain ionic changes and brain abnorman electrical activities
Time frame: 3years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Results publication: PubMed 27330970Wirsich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxime GUYE, MD principal investigator
Assistance Publique Hopitaux De Marseille
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Epileptic Seizures, run by Assistance Publique Hopitaux De Marseille at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02304029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.