Skip to main content
OpenTrials
Completed

NCT Number: NCT03278210

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epilepsy Intractable Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsies, Partial Epilepsy Focal Epilepsy Nervous System Diseases

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Roger Salengro, CHRU de Lille

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

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

    Time frame: 1 year after surgery

    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.

  3. Quality of life score (QOLIE 31)

    Time frame: 1 year after surgery

    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

  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.

    Time frame: 1 year after surgery

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: ENERGY

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2017
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.