Recording Fast Ripples Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate the feasibility of recording fast-ripples, a potential new biomarker of epilepsy, using the new micro-macroelectrodes developed by Dixi-Medical.

Detailed Description
-----------------
Partial epilepsies are refractory to medical treatment in 30% of the cases (Refractory Partial Epilepsy or RPE). Patients with RPE suffer from social and occupational disability, an increased risk associated with seizures (traumatic brain injury, accidents), but also a higher risk of sudden unexplained death (2 to 3 times higher) than the general population. Moreover, the medical and social burden of these patients is heavy, representing a significant cost to society. In some cases, surgical treatment with resection of the epileptogenic zone (EZ) can be proposed. The presurgical evaluation includes various investigations seeking to clarify the location of the EZ; but this approach is sometimes insufficient and the definition of the EZ then requires invasive exploration through intracerebral EEG recording (stereo-EEG, SEEG). This latter technique is currently the preferred standard to define the EZ. It involves implanting electrodes in the brain areas suspected to belong to the seizure network. 50 to 70% of patients investigated with this technique will have epilepsy surgery. In recent years, a series of studies in animals and humans have suggested that some oscillations, very short and at very high frequency (> 250 Hz), called fast ripples (FRs) could be a good biomarker of the EZ (for a review see Zijlmans et al, 2012). The FRs are more easily recorded from microelectrode (diameter: 20-40 microns). The purpose of this study is to evaluate a new medical device designed by DixiMedical to record FRs, combining micro and regular clinical electrodes.

Official Title
-----------------
Feasibility and Interest of Recording Fast Ripples Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Device: intracerebral micro-macroelectrodes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with RPE in whom SEEG is required to precisely localize the seizure focus Exclusion Criteria: Patients with SEEG contra-indication: severe psychiatric disorders, severe agitation during their crisis contraindication for performing an MRI: claustrophobia, a cardiac or neural stimulator, ferromagnetic surgical clips, cochlear implants, intraocular metallic foreign body or in the nervous system, contraindication to intracerebral investigation (macro-electrodes): ongoing infection, severe associated pathology (cardiac, pulmonary, renal, hepatic), pregnant or nursing women, anti thrombotic ongoing treatment.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: micro-macroelectrodes<br>All patients will be implanted with usually 4 intracerebral micro-macroelectrodes(replacing the regular clinical macroelectrodes). The primary and secondary outcomes will then be assessed. | Device: intracerebral micro-macroelectrodes<br>* All patients will be implanted with usually 4 micro-macroelectrodes (replacing the regular clinical macroelectrodes). The primary and secondary outcomes will then be assessed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the feasibility of recording Fast Ripples (FRs) | Proportion of patients who are registered more than 60 FRs per hour the day 3 and the day 4 on the micro-macro electrode in the presumed epileptogenic zone, compared to the number of patients included | During 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the interest of FRs | Sum of FRs recorded over the 5 days. | During 5 days | 
| Evolution of the hourly frequency of FRs | The evolution of the hourly frequency of FRs recorded by the microelectrodes depending on the day of recording. | During 5 days | 
| Effectiveness of microelectrodes and macroelectrodes | Number of FRs stored on the macro-blocks immediately adjacent to the microelectrodes located in the EZ. | During 5 days | 
| safety of micro-macroelectrodes | A quantitative and qualitative description of the side effects associated with the procedure. | During 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fast ripples, Safety, Electrodes, Device, StereoElectroencephalograph, Epileptogenic zone