EPIFAR Clinical Trial: Hybrid Depth Electrodes for Fast Ripple Recording
Benoit Marcy1
1neurosciences, cnrs
Objective:
EPIFAR clinical trial is a bicentric study designed to assess the safety of novel hybrid depth electrodes equipped with tetrodes, and to evaluate the feasibility & clinical value of for multiscale-recording Fast Ripples (FRs).
Background:

Fast Ripples are promising electrophysiological biomarkers initially identified at the microscale using tetrodes. Subsequent studies demonstrated their detectability at the macroscale on standard intracerebral contacts, yet macroscopic findings have remained inconsistent regarding their predictive value. FRs are highly focal events whose occurrence and characteristics depend on recording scale. To address this, new deep hybrid electrodes developed with DIXI Medical integrate deployable tetrodes between standard macro-contacts, enabling simultaneous multi-scale recordings in situ.

Design/Methods:

Fifty-four patients (46 Toulouse, 8 Lyon) were implanted with 173 hybrid electrodes. Recordings were acquired using Blackrock or Neuralynx systems at 2,048 Hz (macro) and >30,000 Hz (micro). FRs were automatically detected during one hour of awake recording per patient using Halyzia software. Safety was assessed through adverse event reporting (ANSM, article R.1123-39 §4) and postoperative MRI. Recording feasibility was evaluated from hourly FR rates at both scales, while biomarker performance was quantified by sensitivity, specificity, and predictive values. All recording contacts were classified based on their localization within the epileptogenic, irritative, or propagation zones.

Results:
No safety concerns were identified. Postoperative MRI showed no additional hemorrhagic marks, hematomas, or linear hypersignals. Macro and micro hourly FR rates were heterogeneous across patients. Sensitivity(0.12), specificity(0.8), PositivePredictiveValue(0.6) and NegativePredictiveValue(0.75). 
Conclusions:
Hybrid electrodes proved safe and feasible for recording FRs at both macro and micro levels. FRs exhibited higher hourly rates at the macro-scale. Sensitivity confirmed their restriction to subregions of the epileptogenic zone, while specificity and predictive values demonstrated their absence in non-epileptogenic tissue and robust localization power.
10.1212/WNL.0000000000216152
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