Clinical trial NCT02491476: Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy
Official title: Feasibility and Interest of Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: Safety
Electrodes
Device
StereoElectroencephalograph
Epileptogenic zone
Fast ripples
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: CerCo, CNRS Cerco UMR5549 CHU Purpan Toulouse France
name: DIXI Medical, Besançon, France
First posted: 2015-07-08
Enrollment: 54
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Evaluation of the feasibility of recording Fast Ripples (FRs)
timeFrame: During 5 days
Secondary outcomes:
measure: Evaluation of the interest of FRs
timeFrame: During 5 days
measure: Evolution of the hourly frequency of FRs
timeFrame: During 5 days
measure: Effectiveness of microelectrodes and macroelectrodes
timeFrame: During 5 days
measure: safety of micro-macroelectrodes
timeFrame: During 5 days
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
state: Midi-Pyrenees
Study officials:
affiliation: University Hospital, Toulouse
name: luc valton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bragin A, Wilson CL, Staba RJ, Reddick M, Fried I, Engel J Jr. Interictal high-frequency oscillations (80-500 Hz) in the human epileptic brain: entorhinal cortex. Ann Neurol. 2002 Oct;52(4):407-15. doi: 10.1002/ana.10291.
citation: Crepon B, Navarro V, Hasboun D, Clemenceau S, Martinerie J, Baulac M, Adam C, Le Van Quyen M. Mapping interictal oscillations greater than 200 Hz recorded with intracranial macroelectrodes in human epilepsy. Brain. 2010 Jan;133(Pt 1):33-45. doi: 10.1093/brain/awp277. Epub 2009 Nov 17.
citation: Demont-Guignard S, Benquet P, Gerber U, Biraben A, Martin B, Wendling F. Distinct hyperexcitability mechanisms underlie fast ripples and epileptic spikes. Ann Neurol. 2012 Mar;71(3):342-52. doi: 10.1002/ana.22610.
citation: Jacobs J, Levan P, Chatillon CE, Olivier A, Dubeau F, Gotman J. High frequency oscillations in intracranial EEGs mark epileptogenicity rather than lesion type. Brain. 2009 Apr;132(Pt 4):1022-37. doi: 10.1093/brain/awn351. Epub 2009 Mar 18.
citation: Jacobs J, Zijlmans M, Zelmann R, Chatillon CE, Hall J, Olivier A, Dubeau F, Gotman J. High-frequency electroencephalographic oscillations correlate with outcome of epilepsy surgery. Ann Neurol. 2010 Feb;67(2):209-20. doi: 10.1002/ana.21847.
citation: Staba RJ, Frighetto L, Behnke EJ, Mathern GW, Fields T, Bragin A, Ogren J, Fried I, Wilson CL, Engel J Jr. Increased fast ripple to ripple ratios correlate with reduced hippocampal volumes and neuron loss in temporal lobe epilepsy patients. Epilepsia. 2007 Nov;48(11):2130-8. doi: 10.1111/j.1528-1167.2007.01225.x. Epub 2007 Jul 28.
citation: Worrell GA, Gardner AB, Stead SM, Hu S, Goerss S, Cascino GJ, Meyer FB, Marsh R, Litt B. High-frequency oscillations in human temporal lobe: simultaneous microwire and clinical macroelectrode recordings. Brain. 2008 Apr;131(Pt 4):928-37. doi: 10.1093/brain/awn006. Epub 2008 Feb 7.
citation: Zijlmans M, Jiruska P, Zelmann R, Leijten FS, Jefferys JG, Gotman J. High-frequency oscillations as a new biomarker in epilepsy. Ann Neurol. 2012 Feb;71(2):169-78. doi: 10.1002/ana.22548.