Multimodal Imaging in Pre-surgical Evaluation of Epilepsy

NCT01735032 | Unknown

• 1 other identifier: 2011-703
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Epilepsy is the most common chronic neurological disorder in the world, affecting more than 50 million people worldwide. Approximately 35% of patients with epilepsy are refractory to all available antiepileptic drugs. Drug-resistant epilepsies are often partial or focal. Patients with drug-resistant focal epilepsy suffer from an increased risk of death, primarily due to seizure-related fatalities, in comparison with the general population. The only therapeutic option for this form of epilepsy is the surgical removal of the region of the brain responsible for seizures, called the epileptogenic zone (EZ). This requires the precise localization of the EZ based on a comprehensive pre-surgical evaluation of patients. Today the gold standard for localizing the EZ and validating a non-invasive technique for localization of the EZ remains intracerebral stereo-EEG (stereo-electroencephalography or SEEG) recordings of spontaneous seizures. The implementation strategy of the intracerebral depth electrodes is guided by clinical and neuroimaging data, including anatomical Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) with FDG (fluoro-Deoxy-Glucose) and MagnetoEncephaloGraphy (MEG). Although the contribution of each technique in the pre-surgical localization of the EZ has already been shown, no wide-scale study has examined the cumulative contribution of these three techniques.

Conditions

Partial Epilepsy

Keywords

focal epilepsy; pre-surgical evaluation; multimodal imaging; SEEG

Outcome Measures

Primary Outcomes (1)

• Localizing value of MEG, FDG-PET and MRI for the determination of the Epileptogenic Zone defined by SEEG recordings

  Pathological volumes defined by multimodal imaging (MEG, FDG-PET and MRI) will be compared to the topography of the EZ defined by SEEG recordings. For each patient, we will sum the total number of intracerebral depth electrodes included in the EZ. Then, for each functional volume obtained from multimodal data fusion, we will count the total number of electrodes in the latter (Vol elec\_tot) and the number of electrodes included in the EZ (Vol elec\_ze).

  180 days

Secondary Outcomes (1)

• sensitivity and specificity

  180 days

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 patients with drug-resistant focal epilepsy and candidates for epilepsy surgery will be recruited.

You may qualify if:

• Patient with drug-resistant focal epilepsy
• Candidates for pre-surgical evaluation including FDG PET, MRI, MEG and SEEG recordings.
• Age 18-65 years
• EEG-confirmed focal epilepsy for \>2 years
• Signed informed consent form.

You may not qualify if:

• Age \<18 years and \>65 years
• Contraindication to the MRI
• Pregnant woman
• Head size incompatible with MEG recordings
• Adult subject to legal protection measure.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Lyon, France

RECRUITING

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

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

Study Officials

• François MAUGUIERE

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien Jung, Dr.

CONTACT

0033 472 117 833; julien.jung@chu-lyon.fr

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: November 28, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2016
• Last Updated: November 30, 2012

Record last verified: 2012-10

Locations

FR (1)