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- Title
Focal Cortex Stimulation With a Novel Implantable Device and Antiseizure Outcomes in 2 Prospective Multicenter Single-Arm Trials.
- Authors
Schulze-Bonhage, Andreas; Hirsch, Martin; Knake, Susanne; Kaufmann, Elisabeth; Kegele, Josua; Rademacher, Michael; Vonck, Kristl; Coenen, Volker Arnd; Glaser, Martin; Jenkner, Carolin; Winter, Yaroslav; Groppa, Sergiu
- Abstract
This pooled analysis of 2 nonrandomized uncontrolled trials investigates the association between epicranial electrical focal cortex stimulation and seizure frequency in drug-refractory focal epilepsy. Key Points: Question: Is long-term treatment using epicranial electrical focal cortex stimulation associated with a reduction in seizure frequency in drug-refractory focal epilepsy? Findings: In 2 nonrandomized trials, 33 adult participants with uncontrolled unifocal epilepsy were implanted with a pulse generator and an electrode array placed above the individual focus region without experiencing device- or procedure-related serious adverse events. A pooled analysis showed a 52% reduction in seizure frequency and at least a 50% response in the sixth month of neurostimulation compared with the prospective baseline. Meaning: Results suggest that focal cortex stimulation with an epicranial electrode array may offer a safe and effective new treatment option for patients with drug-refractory focal epilepsy. Importance: For the large population of people with drug-refractory epilepsy, alternative treatment approaches are needed. Clinical trial outcomes of a novel stimulation device, which is newly available in Europe for the treatment of patients with a predominant seizure focus, are reported for the first time. Objective: To perform a pooled analysis of the results of 2 prospective, multicenter, single-arm trials, A Pilot Study to Assess the Feasibility of Neurostimulation With the EASEE System to Treat Medically Refractory Focal Epilepsy (EASEE II) and A Pilot Study to Assess the Feasibility of Patient-Controlled Neurostimulation With the EASEE System to Treat Medically Refractory Focal Epilepsy (PIMIDES I), assessing the safety and efficacy of epicranial focal cortex stimulation (FCS) with a novel implantable device (EASEE [Precisis]) as adjunctive treatment for adult patients with drug-refractory focal epilepsy. Design, Setting, and Participants: This study was a pooled analysis of 2 nonrandomized uncontrolled trials, EASEE II and PIMIDES I, which began on January 15, 2019, and January 14, 2020, respectively, and ended on July 28, 2021. EASEE II and PIMIDES I were the first in-human, prospective, single-arm trials with an 8-month evaluation period. Patients were recruited at 7 European epilepsy centers. Consecutive participants with drug-refractory focal epilepsy were enrolled. Study data were analyzed from September 29, 2021, to February 2, 2022. Interventions: After a 1-month prospective baseline period, patients were implanted with the neurostimulation device. After a 1-month postimplantation recovery period, unblinded FCS was activated using both high-frequency and direct current (DC)–like components performed via electrode arrays placed epicranially above the individual epileptic focus region. Main Outcomes and Measures: Efficacy was prospectively assessed by the responder rate in the sixth month of stimulation compared with baseline; safety and additional end points were assessed after device implantation and during the stimulation period. Results: Of the 34 adult patients enrolled at 6 German and 1 Belgian investigational site, 33 (mean [SD] age, 34.6 [13.5] years; 18 male patients [54.5%]) received the neurostimulation device implant. A total of 32 patients underwent combined high-frequency direct current–like stimulation at least until the 8-month postimplant follow-up visit. After 6 months of stimulation, 17 of 32 patients (53.1%) were responders to treatment with at least a 50% reduction in seizure frequency compared with baseline, corresponding to a significant median seizure reduction by 52% (95% CI, 0.37%-0.76%; P <.001). No device- or procedure-related serious adverse events were reported (0; 95% CI, 0%-10.58%). There were no significant alterations in cognition, mood, or overall quality of life. Conclusions and Relevance: Results of this pooled analysis of 2 nonrandomized uncontrolled trials suggest that FCS with a novel neurostimulation device was associated with an effective reduction in seizure frequency in patients with drug-refractory focal epilepsy and may offer a promising treatment option for patients with a predominant epileptic focus. Trial Registration: German Clinical Trials Register: DRKS00015918 and DRKS00017833, respectively, and jointly under PROSPERO: CRD42021266440
- Publication
JAMA Neurology, 2023, Vol 80, Issue 6, p588
- ISSN
2168-6149
- Publication type
Article
- DOI
10.1001/jamaneurol.2023.0066