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Clinical Trials/NCT03278210
NCT03278210CompletedNot Applicable

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

University Hospital, Lille1 site in 1 country102 target enrollmentStarted: April 13, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
102
Locations
1
Primary Endpoint
Efficacity of surgery measured by the International League Against Epilepsy (ILAE) scale
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
8 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Percentage of inter-ictal and ictal discharges for localizing the epileptogenic zone by EEG(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)(1 year after surgery)
  • Number of patients who finally underwent a surgery after EEG-fMRI results even if they were considered as non surgical after standard presurgical evaluation(1 year after surgery)
  • Quality of life score (QOLIE 31)(1 year after surgery)
  • Distinction of patients according to the type of their epilepsy: temporal / extra temporal.(1 year after surgery)

Investigators

Sponsor
University Hospital, Lille
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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