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CompletedNCT03278210ENERGYUpdated Dec 3, 2025

National Study on the Interest of EEG-fMRI in the Presurgical Evaluation of Partial Epilepsies Drug

An observational study in Epilepsy Intractable and Focal Epilepsy, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
102
Ages
8 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Epilepsy Intractable
  • Focal Epilepsy

Keywords

  • EEG-fMRI
  • brain imaging
  • presurgical evaluation
  • epilepsy surgery
03

Who can participate

Ages eligible
8 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients followed for a focal intractable epilepsy and engaged in a pre surgical evaluation.

Inclusion criteria

  • > 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
102 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year after surgery

Secondary outcomes

  1. 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

  2. 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.

    Time frame: 1 year after surgery

  3. 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

    Time frame: 1 year after surgery

  4. 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

  5. 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

    Time frame: 1 year after surgery

06

Study locations

1 site
  • Hôpital Roger Salengro, CHRU de Lille
    Lille, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03278210
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Sep 11, 2017
Start date
Apr 13, 2011
Primary completion
Apr 2020
Completion
Apr 2020
Last update
Dec 3, 2025

Study contacts

Louise Tyvaert, MD, PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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