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

NCT ID: NCT03278210

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-13

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Epilepsy Intractable Focal Epilepsy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Louise Tyvaert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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HĂ´pital Roger Salengro, CHRU de Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2010-A01101-38

Identifier Type: OTHER

Identifier Source: secondary_id

2009_54/1021

Identifier Type: -

Identifier Source: org_study_id

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