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

U

University Hospital, Lille

Status

Completed

Conditions

Focal Epilepsy
Epilepsy Intractable

Study type

Observational

Funder types

Other

Identifiers

NCT03278210
2009_54/1021
2010-A01101-38 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

All

Ages

8+ years old

Volunteers

No Healthy Volunteers

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

Trial design

102 participants in 2 patient groups

with EEG-fMRI data
Description:
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
Description:
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.

Trial contacts and locations

1

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Central trial contact

Louise Tyvaert, MD,PhD

Data sourced from clinicaltrials.gov

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