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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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.


Condition or disease
Epilepsy Intractable Focal Epilepsy

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Study Type : Observational
Estimated Enrollment : 290 participants
Observational Model: Case-Control
Time Perspective: Prospective
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


Group/Cohort
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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.

  3. 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

  4. 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 ]
  5. 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



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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients followed for a focal intractable epilepsy and engaged in a pre surgical evaluation.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Louise Tyvaert, MD,PhD l.tyvaert@chru-nancy.fr

Locations
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France
Hôpital Roger Salengro, CHRU de Lille Recruiting
Lille, France
Principal Investigator: Philippe Derambure, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Louise Tyvaert, MD, PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03278210     History of Changes
Other Study ID Numbers: 2009_54/1021
2010-A01101-38 ( Other Identifier: ID-RCB number, ANSM )
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Lille:
EEG-fMRI
brain imaging
presurgical evaluation
epilepsy surgery
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Partial
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases