National Study on the Interest of EEG-fMRI in the Presurgical Evaluation of Partial Epilepsies Drug (ENERGY)
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|ClinicalTrials.gov Identifier: NCT03278210|
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : June 26, 2019
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.
|Condition or disease|
|Epilepsy Intractable Focal Epilepsy|
|Study Type :||Observational|
|Estimated Enrollment :||290 participants|
|Official Title:||National Study on the Interest of EEG-fMRI in the Presurgical Evaluation of Partial Epilepsies Drug|
|Actual Study Start Date :||April 13, 2011|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
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.
- 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.
- 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 ]
- 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.
- 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
- 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 ]
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278210
|Contact: Louise Tyvaert, MD,PhDfirstname.lastname@example.org|
|Hôpital Roger Salengro, CHRU de Lille||Recruiting|
|Principal Investigator: Philippe Derambure, MD,PhD|
|Principal Investigator:||Louise Tyvaert, MD, PhD||University Hospital, Lille|