PIMIDES I: a pilot study to assess the feasibility of patient-controlled neurostimulation with the EASEE® system to treat medically refractory focal epilepsy

Abstract

The study design of PIMIDES, a trial based on patient-individualized transcranial electric neurostimulation of epileptic foci, is reported. Inclusion criteria include a predominant epileptic focus and pharmacoresistance to two antiepileptic drug treatments. The study is prospective, unblinded, and serves to assess the safety of subgaleal implantation and transcranial stimulation.

Poly(3,4‐ethylenedioxythiophene)‐Based Neural Interfaces for Recording and Stimulation: Fundamental Aspects and In Vivo Applications

“…Such neuromodulation typically employs signals with slower dynamics than the bi‐phasic pulses described above, as the intention is not eliciting action potentials in single neurons, instead to influence the network on system level ( Table 2 ). [ 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 ] Common terms to describe the signals are alternating current stimulation (ACS), typically a sinusoidal signal in the 0.1–200 Hz range, and direct current stimulation (DCS). For the latter, the DC stimulation is commonly “dosed” in asymmetric pulses, but with pulse lengths closer to the seconds to minute range, than the sub‐millisecond.…”

“…Cognitive enhancement [35] Depression [36] Focal epilepsy [ 37,38] Low frequency stimulation (<10 Hz) Transcranial: 0.5-10 Hz, 1-4 mA Subcortical: 2-4 Hz…”

The Challenging Path to Developing a Mobile Health Device for Epilepsy: The Current Landscape and Where We Go From Here

“…The capacity to foresee a seizure event would transform epilepsy care and ultimately allow patients to counteract impending seizures by proactively adapting their behavior. For example, a patient could potentially self-target neurostimulation to abort the seizure (40), or rely on a closed-loop apparatus that offered immediate seizure-triggered therapy (41).…”

Conductive Polymers for Bidirectional Neural Interfaces: Fundamentals Aspects and in Vivo Applications

“…Longer pulses are only possible by engaging additional faradaic charge injection mechanisms on the surface, and therefore put the electrodes at higher risk for corrosion or similar electrochemically driven degradation. Depression [32] Focal epilepsy [33,34] Low frequency stimulation (<10 Hz) Transcranial 0.5-10 Hz, 1-4 mA…”

“…Focal epilepsy (EASEE-Device) [34] Subortical 2-4 Hz Focal epilepsy [35,36] High frequency stimulation (>100 Hz) Focal epilepsy [34] Epicortical 30-90 Hz 100/200 Hz Gating modulation Interference with ictal Pain [37] Focal epilepsy Amplitude 80% motor threshold pattern generation (RNS-Device [38] ) Pain [37] Psychiatric disorders (Obsessionalcompulsive disorders, depression) [39] Focal epilepsy (Thalamic stimulation [40] , focus stimulation [38] )…”