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Feasibility, Safety, and Performance of Full-Head Subscalp EEG Using Minimally Invasive Electrode Implantation
Ellen van Maren1, Sigurd L Alnes1, Janir Ramos da Cruz1
1From the NeuroTec (E.v.M., S.L.A., C.F.-M., K.W., S.F., M.F., A.T., K.S., M.O.B.), Center for Sleep-Wake-Epilepsy, Center for Experimental Neurology, Department of Neurology, Inselspital Bern, University Hospital, and Institute of Computer Science (S.L.A., A.T.), University of Bern; Wyss Center for Bio and Neuroengineering (J.R.d.C., A.S., I.V., J.Z., T.B., G.K.), Geneva; Department of Neurosurgery (S.L.B., W.J.Z.G., C.P.), Inselspital Bern, University Hospital, University of Bern, Switzerland; and Department of Neuroscience (J.D.), Brown University, Providence, RI.
This study shows that minimally invasive subscalp electroencephalography (EEG) is a safe and effective method for monitoring brain activity. This new approach offers non-inferior results compared to traditional scalp EEG for detecting brain oscillations and seizures.
Area of Science:
- Neuroscience
- Biomedical Engineering
- Medical Devices
Background:
- Current clinical neurophysiology relies on short-term EEG recordings, limiting long-term brain function monitoring.
- Effective management of chronic neurological disorders like epilepsy requires continuous, real-world brain activity monitoring.
- Subscalp EEG offers a potential solution for extended brain monitoring in daily life.
Purpose of the Study:
- To assess the feasibility and safety of a novel full-head subscalp EEG device (Epios) using a minimally invasive technique.
- To compare the efficacy of subscalp EEG with conventional scalp EEG in measuring brain oscillations and epileptic discharges.
Main Methods:
- Eight participants with drug-resistant epilepsy received subscalp electrodes during intracranial EEG surgery.
- Safety was monitored post-procedure for up to 9 days.
- Subscalp, scalp, and intracranial EEG signals were quantitatively compared for brain oscillations and seizure activity.
Main Results:
- Up to 28 subscalp electrodes were safely implanted via small incisions in a single procedure.
- No serious adverse events occurred; minor events resolved.
- Subscalp EEG demonstrated non-inferiority to scalp EEG in measuring brain oscillations and detecting interictal spikes and ictal signals (ICC >0.8).
Conclusions:
- Full-head subscalp EEG recording is feasible and safe for up to 9 days in humans via minimally invasive techniques.
- This method is non-inferior to current scalp EEG standards for brain activity monitoring.
- Further ambulatory studies are needed to confirm long-term safety and utility.
