Efficacy and tolerability of Transcranial Focus Stimulation - results from two clinical trials
Abstract number :
2.419
Submission category :
3. Neurophysiology / 3E. Brain Stimulation
Year :
2022
Submission ID :
2232996
Source :
www.aesnet.org
Presentation date :
12/4/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:29 AM
Authors :
Martin Hirsch, MD – 1University Hospital Freiburg, Epileptology, Freiburg, Germany; Sergiu Groppa, Prof. – University Hospital Mainz, Neurology, Mainz, Germany; Elisabeth Kaufmann, MD – University Hospital Munich, Neurology, Munich, Germany; Josua Kegele, MD – University Hospital Tübingen, Neurology, Tübingen, Germany,; Susanne Knake, Prof. – University Hospital Marburg, Neurology, Marburg, Germany; Nichael Rademacher, MD – University Hospital Bonn, Epileptology, Bonn, Germany; Andres Schulze-Bonhage, Prof. – University Hospital Freiburg, Epileptology, Freiburg, Germany; Kristil Vonck, Prof. – University Hospital Gent, Neurology, Gent, Belgium; Yaroslav Winter, MD – University Hospital Mainz, Neurology
This is a Late Breaking abstract
Rationale: For people with pharmacoresistant focal epilepsy, new treatment options are needed. Neuromodulation is one alternative, with evidence for efficacy so far with stimulation of the vagus nerve, anterior nuclei of the thalamus, and for intracranial responsive stimulation of the epileptic focus. We here present pooled results from two clinical trials applying a minimally invasive approach, transcranial focal cortex stimulation (FCS), using an epicranially implanted device ("EASEE“) for stimulation of the focal region.
Methods: A total of 33 participants (18 male, 15 female, age 18-75 y, mean age 34.6 y) were implanted with a stimulation device with five electrode contacts placed epicranially , with a Laplace-like electrode configuration. Placement of the electrodes was performed according to the individual epileptogenic focus, as based on clinical and EEG information. Stimulation was performed via a pulse generator connected to the epicranial electrode, placed in the pectoral region. Unblinded combined high frequency (100 Hz AC) and cathodal DC-like stimulation were performed in combination, with AC stimulation distributed over the day, and DC-like stimulation for a period of 20 min/day. Seventeen patients could additionally trigger AC stimulation when perceiving seizure symptoms. Intraindividual effects on monthly seizure frequency were analyzed using a mixed-effects Poisson regression model.
Results: Stimulation was activated in 32 patients. During the stimulation period, a gradual decline in seizure frequency occurred, with a reduction of the mean total seizure frequency from 33.7/month at baseline to 17.3/month in month 6 (p < 0.001), corresponding to a responder rate of 53.13 % (95 % CI: 34.74 - 70.91 %). _x000D_
Implantation-related adverse events mostly consisted of transient local pain at the implantation site. There were no stimulation-emergent serious adverse events.
Neurophysiology