Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy (Epi-FaR)
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
intracerebral micro-macroelectrodes
Sponsored by
About this trial
This is an interventional basic science trial for Epilepsy focused on measuring Safety, Electrodes, Device, StereoElectroencephalograph, Epileptogenic zone, Fast ripples
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.
Sites / Locations
- University Hospital Toulouse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
micro-macroelectrodes
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Evaluation of the interest of FRs
Sum of FRs recorded over the 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.
Effectiveness of microelectrodes and macroelectrodes
Number of FRs stored on the macro-blocks immediately adjacent to the microelectrodes located in the EZ.
safety of micro-macroelectrodes
A quantitative and qualitative description of the side effects associated with the procedure.
Full Information
NCT ID
NCT02491476
First Posted
June 1, 2015
Last Updated
June 5, 2023
Sponsor
University Hospital, Toulouse
Collaborators
CerCo, CNRS Cerco UMR5549 CHU Purpan Toulouse France, DIXI Medical, Besançon, France
1. Study Identification
Unique Protocol Identification Number
NCT02491476
Brief Title
Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy
Acronym
Epi-FaR
Official Title
Feasibility and Interest of Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
August 18, 2022 (Actual)
Study Completion Date
September 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
CerCo, CNRS Cerco UMR5549 CHU Purpan Toulouse France, DIXI Medical, Besançon, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Safety, Electrodes, Device, StereoElectroencephalograph, Epileptogenic zone, Fast ripples
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
micro-macroelectrodes
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
intracerebral micro-macroelectrodes
Intervention Description
All patients will be implanted with usually 4 micro-macroelectrodes (replacing the regular clinical macroelectrodes). The primary and secondary outcomes will then be assessed.
Primary Outcome Measure Information:
Title
Evaluation of the feasibility of recording Fast Ripples (FRs)
Description
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
Time Frame
During 5 days
Secondary Outcome Measure Information:
Title
Evaluation of the interest of FRs
Description
Sum of FRs recorded over the 5 days.
Time Frame
During 5 days
Title
Evolution of the hourly frequency of FRs
Description
The evolution of the hourly frequency of FRs recorded by the microelectrodes depending on the day of recording.
Time Frame
During 5 days
Title
Effectiveness of microelectrodes and macroelectrodes
Description
Number of FRs stored on the macro-blocks immediately adjacent to the microelectrodes located in the EZ.
Time Frame
During 5 days
Title
safety of micro-macroelectrodes
Description
A quantitative and qualitative description of the side effects associated with the procedure.
Time Frame
During 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
luc valton, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
State/Province
Midi-Pyrenees
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
12325068
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.
Results Reference
background
PubMed Identifier
19920064
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.
Results Reference
background
PubMed Identifier
22451202
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.
Results Reference
background
PubMed Identifier
19297507
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.
Results Reference
background
PubMed Identifier
20225281
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.
Results Reference
background
PubMed Identifier
17662059
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.
Results Reference
background
PubMed Identifier
18263625
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.
Results Reference
background
PubMed Identifier
22367988
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.
Results Reference
background
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Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy
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