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

NCT03278210 | Completed

• 2 other identifiers: 2009_54/10212010-A01101-38
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy Intractable; Focal Epilepsy

Keywords

EEG-fMRI; brain imaging; presurgical evaluation; epilepsy surgery

Outcome Measures

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.

  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

  1 year after surgery

• Percentage of inter-ictal and ictal discharges for localizing the epileptogenic zone by EEG

  1 year after surgery

• Quality of life score (QOLIE 31)

  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

• Distinction of patients according to the type of their epilepsy: temporal / extra temporal.

  1 year after surgery

Study Arms (2)

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.

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro, CHRU de Lille

Lille, France

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsies, Partial

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Louise Tyvaert, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: September 11, 2017
• Study Start: April 13, 2011
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)