Epilepsy IntractableENERGYNCT03278210
National Study on the Interest of EEG-fMRI in the Presurgical Evaluation of Partial Epilepsies Drug
An observational study of Epilepsy Intractable and Focal Epilepsy, run by University Hospital, Lille at 1 site in France.
Trial summary
The main goal of this study is to evaluate the additional value of EEG-fMRI method in the presurgical evaluation of focal intractable epilepsy. To consider a patient for surgery, the main difficulty is to define accurately the epileptogenic zone. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Epilepsy Intractable, Focal Epilepsy
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2011to Apr 2020
- Phase
- Observational
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients followed for a focal intractable epilepsy and engaged in a pre surgical evaluation.
Who may be able to join
- > 8 years old
- intractable focal epilepsy
- presurgical evaluation or "phase 1" planified
- with focal EEG activity : more than 3 EEG interictal epileptic events per hour
- patient and/or legal representant given their written consent for their participation in the study
Who cannot join
- MRI contraindication
- pregnancy
- uncomfortable prolonged lying position
- frequent primary or secondary generalised seizure with tonic clonic movements (>2 per week)
- previous epilepsy surgery
- important mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
The main goal of this study is to evaluate the additional value of EEG-fMRI method in the presurgical evaluation of focal intractable epilepsy.
To consider a patient for surgery, the main difficulty is to define accurately the epileptogenic zone. This definition is complex and is often supported by several types of exploration (MRI, FDG PET, neuropsychological testing, video-EEG...). In this study we will evaluate the adding value of the simultaneous recording of EEG and fMRI in the epileptogenic zone definition.
- Conditions
- Epilepsy Intractable, Focal Epilepsy
- Keywords
- EEG-fMRI, brain imaging, presurgical evaluation, epilepsy surgery
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| with EEG-fMRI data | EEG-fMRI was performed during the pre surgical evaluation, and its results were provided to the clinicians before surgery planification. The final surgery strategy was decided with EEG-fMRI results. | |
| without EEG-fMRI data | EEG-fMRI was performed during the pre surgical evaluation, but clinicians were blinded to the results. The final surgery strategy was decided without EEG-fMRI results. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacity of surgery measured by the International League Against Epilepsy (ILAE) scale
A score between 1-4 reflects an improvement in epilepsy and between 5-6 a lack of improvement.
Measured: 1 year after surgery
Secondary outcomes (5)
Number of patients who finally underwent a surgery after EEG-fMRI results even if they were considered as non surgical after standard presurgical evaluation
Measured: 1 year after surgery
Percentage of inter-ictal and ictal discharges for localizing the epileptogenic zone by EEG
The percentage of non-localizing or lateralizing data (score 4 on the evaluation grid) will be calculated in relation to the total number of acquired victual data and compared with the equivalent percentage corresponding to the inter-state data.
Measured: 1 year after surgery
Quality of life score (QOLIE 31)
Comparison of the evolution of quality of life indices to 1 year of epilepsy surgery between the two groups using French versions of QOLIE 31 scales
Measured: 1 year after surgery
Number of patients who finally underwent a surgery after EEG-fMRI results on SEEG implantation strategy after standard presurgical evaluation(concluded to a surgical management or an SEEG)
Measured: 1 year after surgery
Distinction of patients according to the type of their epilepsy: temporal / extra temporal.
measure of the "type of epilepsy" effect on all the parameters studied re-evaluation of the points taking into account this distinction: main criterion, secondary criteria
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start13 Apr 2011
- Primary completionApr 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy IntractableStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise Tyvaert, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278210
- Sponsor's protocol ID
- 2009_54/1021
- Other IDs
- 2010-A01101-38
- Acronym
- ENERGY
- Status last verified
- Dec 2025
- First submitted
- 4 Jan 2017
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Study on the Interest of EEG-fMRI in the Presurgical Evaluation of Partial Epilepsies Drug
- ClinicalTrials.gov ID
- NCT03278210
- Acronym / sponsor ID
- ENERGY / 2009_54/1021
- Conditions
- Epilepsy Intractable, Focal Epilepsy
- Keywords
- EEG-fMRI, brain imaging, presurgical evaluation, epilepsy surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 13 Apr 2011 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 11 Sep 2017 (actual)
- 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.
The main goal of this study is to evaluate the additional value of EEG-fMRI method in the presurgical evaluation of focal intractable epilepsy.
To consider a patient for surgery, the main difficulty is to define accurately the epileptogenic zone. This definition is complex and is often supported by several types of exploration (MRI, FDG PET, neuropsychological testing, video-EEG...). In this study we will evaluate the adding value of the simultaneous recording of EEG and fMRI in the epileptogenic zone definition.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with EEG-fMRI data | – | –EEG-fMRI was performed during the pre surgical evaluation, and its results were provided to the clinicians before surgery planification. The final surgery strategy was decided with EEG-fMRI results. |
| without EEG-fMRI data | – | –EEG-fMRI was performed during the pre surgical evaluation, but clinicians were blinded to the results. The final surgery strategy was decided without EEG-fMRI results. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients followed for a focal intractable epilepsy and engaged in a pre surgical evaluation.
Key inclusion criteria (5 listed)
- > 8 years old
- intractable focal epilepsy
- presurgical evaluation or "phase 1" planified
- with focal EEG activity : more than 3 EEG interictal epileptic events per hour
- patient and/or legal representant given their written consent for their participation in the study
Key exclusion criteria (6 listed)
- MRI contraindication
- pregnancy
- uncomfortable prolonged lying position
- frequent primary or secondary generalised seizure with tonic clonic movements (>2 per week)
- previous epilepsy surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacity of surgery measured by the International League Against Epilepsy (ILAE) scale
Time frame: 1 year after surgery
A score between 1-4 reflects an improvement in epilepsy and between 5-6 a lack of improvement.
5 secondary outcomes
Number of patients who finally underwent a surgery after EEG-fMRI results even if they were considered as non surgical after standard presurgical evaluation
Time frame: 1 year after surgery
Percentage of inter-ictal and ictal discharges for localizing the epileptogenic zone by EEG
Time frame: 1 year after surgery
Quality of life score (QOLIE 31)
Time frame: 1 year after surgery
Number of patients who finally underwent a surgery after EEG-fMRI results on SEEG implantation strategy after standard presurgical evaluation(concluded to a surgical management or an SEEG)
Time frame: 1 year after surgery
Distinction of patients according to the type of their epilepsy: temporal / extra temporal.
Time frame: 1 year after surgery
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 3 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Louise Tyvaert, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy Intractable and Focal Epilepsy, run by University Hospital, Lille at 1 site 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 5 inclusion and 6 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 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Efficacity of surgery measured by the International League Against Epilepsy (ILAE) scale (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2025.