Feasibility, Safety, and Performance of Full-Head Subscalp EEG Using Minimally Invasive Electrode Implantation.

Humans Male Feasibility Studies Female Adult Electrodes, Implanted Electroencephalography / methods Drug Resistant Epilepsy / surgery Young Adult Middle Aged Minimally Invasive Surgical Procedures / methods Scalp Brain / surgery

Journal

Neurology
ISSN: 1526-632X
Titre abrégé: Neurology
Pays: United States
ID NLM: 0401060

Informations de publication

Date de publication:
25 Jun 2024
Historique:
medline: 6 6 2024
pubmed: 6 6 2024
entrez: 6 6 2024
Statut: ppublish

Résumé

Current practice in clinical neurophysiology is limited to short recordings with conventional EEG (days) that fail to capture a range of brain (dys)functions at longer timescales (months). The future ability to optimally manage chronic brain disorders, such as epilepsy, hinges upon finding methods to monitor electrical brain activity in daily life. We developed a device for full-head subscalp EEG (Epios) and tested here the feasibility to safely insert the electrode leads beneath the scalp by a minimally invasive technique (primary outcome). As secondary outcome, we verified the noninferiority of subscalp EEG in measuring physiologic brain oscillations and pathologic discharges compared with scalp EEG, the established standard of care. Eight participants with pharmacoresistant epilepsy undergoing intracranial EEG received in the same surgery subscalp electrodes tunneled between the scalp and the skull with custom-made tools. Postoperative safety was monitored on an inpatient ward for up to 9 days. Sleep-wake, ictal, and interictal EEG signals from subscalp, scalp, and intracranial electrodes were compared quantitatively using windowed multitaper transforms and spectral coherence. Noninferiority was tested for pairs of neighboring subscalp and scalp electrodes with a Bland-Altman analysis for measurement bias and calculation of the interclass correlation coefficient (ICC). As primary outcome, up to 28 subscalp electrodes could be safely placed over the entire head through 1-cm scalp incisions in a ∼1-hour procedure. Five of 10 observed perioperative adverse events were linked to the investigational procedure, but none were serious, and all resolved. As a secondary outcome, subscalp electrodes advantageously recorded EEG percutaneously without requiring any maintenance and were noninferior to scalp electrodes for measuring (1) variably strong, stage-specific brain oscillations (alpha in wake, delta, sigma, and beta in sleep) and (2) interictal spikes peak-potentials and ictal signals coherent with seizure propagation in different brain regions (ICC >0.8 and absence of bias). Recording full-head subscalp EEG for localization and monitoring purposes is feasible up to 9 days in humans using minimally invasive techniques and noninferior to the current standard of care. A longer prospective ambulatory study of the full system will be necessary to establish the safety and utility of this innovative approach. clinicaltrials.gov/study/NCT04796597.

Sections du résumé

BACKGROUND AND OBJECTIVES OBJECTIVE
Current practice in clinical neurophysiology is limited to short recordings with conventional EEG (days) that fail to capture a range of brain (dys)functions at longer timescales (months). The future ability to optimally manage chronic brain disorders, such as epilepsy, hinges upon finding methods to monitor electrical brain activity in daily life. We developed a device for full-head subscalp EEG (Epios) and tested here the feasibility to safely insert the electrode leads beneath the scalp by a minimally invasive technique (primary outcome). As secondary outcome, we verified the noninferiority of subscalp EEG in measuring physiologic brain oscillations and pathologic discharges compared with scalp EEG, the established standard of care.
METHODS METHODS
Eight participants with pharmacoresistant epilepsy undergoing intracranial EEG received in the same surgery subscalp electrodes tunneled between the scalp and the skull with custom-made tools. Postoperative safety was monitored on an inpatient ward for up to 9 days. Sleep-wake, ictal, and interictal EEG signals from subscalp, scalp, and intracranial electrodes were compared quantitatively using windowed multitaper transforms and spectral coherence. Noninferiority was tested for pairs of neighboring subscalp and scalp electrodes with a Bland-Altman analysis for measurement bias and calculation of the interclass correlation coefficient (ICC).
RESULTS RESULTS
As primary outcome, up to 28 subscalp electrodes could be safely placed over the entire head through 1-cm scalp incisions in a ∼1-hour procedure. Five of 10 observed perioperative adverse events were linked to the investigational procedure, but none were serious, and all resolved. As a secondary outcome, subscalp electrodes advantageously recorded EEG percutaneously without requiring any maintenance and were noninferior to scalp electrodes for measuring (1) variably strong, stage-specific brain oscillations (alpha in wake, delta, sigma, and beta in sleep) and (2) interictal spikes peak-potentials and ictal signals coherent with seizure propagation in different brain regions (ICC >0.8 and absence of bias).
DISCUSSION CONCLUSIONS
Recording full-head subscalp EEG for localization and monitoring purposes is feasible up to 9 days in humans using minimally invasive techniques and noninferior to the current standard of care. A longer prospective ambulatory study of the full system will be necessary to establish the safety and utility of this innovative approach.
TRIAL REGISTRATION INFORMATION UNASSIGNED
clinicaltrials.gov/study/NCT04796597.

Identifiants

DOI: 10.1212/WNL.0000000000209428 PMID: 38843489
pubmed: 38843489
doi: 10.1212/WNL.0000000000209428
doi:

Banques de données

ClinicalTrials.gov
['NCT04796597']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e209428

Auteurs

Ellen van Maren (E)

From 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.
ORCID: 0009-0007-9476-670X

Sigurd L Alnes (SL)

From 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.

Janir Ramos da Cruz (J)

From 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.
ORCID: 0000-0001-7029-5092

Aleksander Sobolewski (A)

From 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.

Cecilia Friedrichs-Maeder (C)

From 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.

Katharina Wohler (K)

From 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.

Sabry L Barlatey (SL)

From 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.
ORCID: 0000-0002-0105-7223

Sandy Feruglio (S)

From 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.

Markus Fuchs (M)

From 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.

Ioannis Vlachos (I)

From 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.

Jonas Zimmermann (J)

From 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.
ORCID: 0000-0001-9225-2595

Tiago Bertolote (T)

From 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.

Werner J Z'Graggen (WJ)

From 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.
ORCID: 0000-0002-5684-4419

Athina Tzovara (A)

From 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.

John Donoghue (J)

From 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.
ORCID: 0000-0002-9394-6940

George Kouvas (G)

From 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.

Kaspar Schindler (K)

From 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.

Claudio Pollo (C)

From 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.

Maxime O Baud (MO)

From 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.
ORCID: 0000-0002-8297-7696

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Feasibility, Safety, and Performance of...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études de faisabilité › Feasibility, Safety, and Performance of...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Feasibility, Safety, and Performance of...
questionsmedicales.fr › Équipement et fournitures › Prothèses et implants › Électrodes implantées › Feasibility, Safety, and Performance of...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Électrodiagnostic › Électroencéphalographie › Feasibility, Safety, and Performance of...
questionsmedicales.fr › Maladies du système nerveux › Maladies du système nerveux central › Encéphalopathies › Épilepsie › Épilepsie pharmacorésistante › Feasibility, Safety, and Performance of...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Jeune adulte › Feasibility, Safety, and Performance of...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › Feasibility, Safety, and Performance of...
questionsmedicales.fr › Procédures de chirurgie opératoire › Interventions chirurgicales mini-invasives › Feasibility, Safety, and Performance of...
questionsmedicales.fr › Régions du corps › Tête › Cuir chevelu › Feasibility, Safety, and Performance of...
questionsmedicales.fr › Système nerveux › Système nerveux central › Encéphale › Feasibility, Safety, and Performance of...