University Hospital Toulouse
Toulouse, Midi-Pyrenees, 31059, France
NCT Number: NCT02491476
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.
Looking for future studies?
Notify Me12 year–65 year
All sexes
Interventional
Not applicable
Toulouse, Midi-Pyrenees, 31059, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with SEEG contra-indication:
All patients will be implanted with usually 4 micro-macroelectrodes (replacing the regular clinical macroelectrodes). The primary and secondary outcomes will then be assessed.
Time frame: During 5 days
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
Sum of FRs recorded over the 5 days.
Time frame: During 5 days
The evolution of the hourly frequency of FRs recorded by the microelectrodes depending on the day of recording.
Time frame: During 5 days
Number of FRs stored on the macro-blocks immediately adjacent to the microelectrodes located in the EZ.
Time frame: During 5 days
A quantitative and qualitative description of the side effects associated with the procedure.
University Hospital, Toulouse
Other
Feasibility and Interest of Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy
Acronym: Epi-FaR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06352372
Autism Spectrum Disorder, Autistic Disorder
Phoenix, Arizona, United States
View Trial DetailsNCT06546410
Brain Diseases, Central Nervous System Diseases
Liverpool, United Kingdom
View Trial DetailsNCT07689084
Brain Diseases, Central Nervous System Diseases
Marburg, Hesse, Germany
View Trial DetailsNCT07689617
Brain Diseases, Central Nervous System Diseases
Elâzığ, Turkey (Türkiye)
View Trial Details