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

Focal Epilepsy Clinical Trial

— ENERGY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03278210
• Other study ID #: 2009_54/1021
• Secondary ID: 2010-A01101-38
• Status: Recruiting
• Start date: April 13, 2011
• Est. completion date: April 2020

Study information

• Verified date: June 2019
• Source: University Hospital, Lille
• Contact: Louise Tyvaert, MD,PhD
• Email: l.tyvaert[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsies, Partial
• Epilepsy
• Epilepsy Intractable
• Focal Epilepsy

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHRU de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Percentage of inter-ictal and ictal discharges for localizing the epileptogenic zone by EEG	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.	1 year after surgery
Secondary	Quality of life score (QOLIE 31)	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	1 year after surgery
Secondary	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
Secondary	Distinction of patients according to the type of their epilepsy: temporal / extra temporal.	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	1 year after surgery