2-year Outcomes of Epicranial Focal Cortex Stimulation with the Easee-system in Pharmacoresistant Focal Epilepsy
Abstract number :
1.269
Submission category :
3. Neurophysiology / 3E. Brain Stimulation
Year :
2024
Submission ID :
865
Source :
www.aesnet.org
Presentation date :
12/7/2024 12:00:00 AM
Published date :
Authors :
Presenting Author: Andreas Schulze-Bonhage, MD – University Hospital Freiburg
Martin Hirsch, MD – University Hospital Freiburg
Susanne Knake, MD – University Hospital Marburg
Elisabeth Kaufmann, MD – Ludwig-Maximilan's University, Munich
Jusua Kegele, MD – University of Tuebingen
Miachael Rademacher, MD – University Hospital Bonn
Kristl Vonck, MD – University of Gent
Volker Coenen, MD – University Hospital Freiburg
Martin Glaser, MD – University Hospital Mainz
Sergiu Groppa, MD – University Hospital Mainz
Yaroslav Winter, MD – University Hospital Mainz
Rationale: To assess long-term efficacy and tolerability of a new neurostimulation technique, focal cortex stimulation (FCS) using the epicranially placed EASEE-electrode array. FCS has been shown to be an efficacious treatment in two single arm trials (EASEE-II and PIMIDES-I; Schulze-Bonhage et al, JAMA Neurology 2023); here long-term efficacy is reported based on later follow-up investigations of the study populations.
Methods: In both trials, a total of 33 patients (18 male, 15 female, age 18-75 y, mean age 34,6 y) from seven epilepsy centers in Germany and Belgium underwent implantation of the neurostimulation system consisting of a pulse generator and a 5-channel electrode array, delivering FCS epicranially above the individual region of the epileptic focus. Stimulation consisted of DC-like stimulation (DLS) for 20 minutes per day and of high frequency stimulation (HFS) distributed over the day. The analysis was performed over a period of 2 years with regard to efficacy (responder rates, monthly seizure frequency) and tolerability.
Results:
81% of the patients who had started stimulation continued FCS treatment over the period of 2 years. The responder rate was 41.4% after 1 year (n=29) and 65.4 % after 2 years (n=26). In the last month of follow-up, 44.0% of patients had a more than 75% percent seizure reduction, and 30.8% of patients had a more than 90% seizure reduction. The median monthly seizure frequency decreased from 12/months to 8/month after one year and to 5/month after 1.5 and 2 years, corresponding to a median reduction in seizures frequency of 33% after 12 months (n=29) and 68% after 18 und 24 months (n=26). There were no severe adverse events related to neurostimulation.
Conclusions: The pooled analyses of long-term outcomes from two unblinded, prospective trials with FCS confirm a seizure reduction and an increasing percentage of responders over a period of 2 years. Long-term results suggest that epicranial Focal Cortex Stimulation with the EASEE systems is an effective and well tolerated new treatment approach for patients with pharmacoresistant focal epilepsy.
Funding: The project was in part funded by the German Ministery of Science and by the Company Precisis.
Neurophysiology