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Assessment of Safety of a Fully Implanted Endovascular Brain-Computer Interface for Severe Paralysis in 4 Patients: The Stentrode With Thought-Controlled Digital Switch (SWITCH) Study.
Mitchell, Peter; Lee, Sarah C M; Yoo, Peter E; Morokoff, Andrew; Sharma, Rahul P; Williams, Daryl L; MacIsaac, Christopher; Howard, Mark E; Irving, Lou; Vrljic, Ivan; Williams, Cameron; Bush, Steven; Balabanski, Anna H; Drummond, Katharine J; Desmond, Patricia; Weber, Douglas; Denison, Timothy; Mathers, Susan; O'Brien, Terence J; Mocco, J; Grayden, David B; Liebeskind, David S; Opie, Nicholas L; Oxley, Thomas J; Campbell, Bruce C V.
Afiliação
  • Mitchell P; Department of Radiology, The University of Melbourne, The Royal Melbourne Hospital, Parkville, Australia.
  • Lee SCM; Neurology, Calvary Healthcare Bethlehem, Parkdale, Australia.
  • Yoo PE; Synchron Inc, New York, New York.
  • Morokoff A; Parkville Neurosurgery, The University of Melbourne, Royal Melbourne Hospital, Parkville, Australia.
  • Sharma RP; Stanford Healthcare Cardiovascular Medicine, Stanford University, Stanford, California.
  • Williams DL; Department of Anaesthesia and Pain Management, The University of Melbourne, The Royal Melbourne Hospital, Parkville, Australia.
  • MacIsaac C; Intensive Care Department, The University of Melbourne, The Royal Melbourne Hospital, Parkville, Australia.
  • Howard ME; Victorian Respiratory Support Service, Austin Health, Heidelberg, Australia.
  • Irving L; Peter MacCallum Cancer Centre, The University of Melbourne, The Royal Melbourne Hospital, Melbourne, Australia.
  • Vrljic I; Department of Radiology, The University of Melbourne, The Royal Melbourne Hospital, Parkville, Australia.
  • Williams C; Department of Neurology, The University of Melbourne, The Royal Melbourne Hospital, Parkville, Australia.
  • Bush S; Department of Neurology, The University of Melbourne, The Royal Melbourne Hospital, Parkville, Australia.
  • Balabanski AH; Department of Neurology, The University of Melbourne, The Royal Melbourne Hospital, Parkville, Australia.
  • Drummond KJ; Melbourne Brain Centre, The University of Melbourne, The Royal Melbourne Hospital, Parkville, Australia.
  • Desmond P; Department of Neuroscience, Alfred Brain, Alfred Health, Melbourne, Australia.
  • Weber D; Department of Neurosurgery, The University of Melbourne, The Royal Melbourne Hospital, Parkville, Australia.
  • Denison T; Department of Radiology, The University of Melbourne, The Royal Melbourne Hospital, Parkville, Australia.
  • Mathers S; Department of Biomedical Engineering, College of Engineering, Carnegie Mellon University, Pittsburgh, Pennsylvania.
  • O'Brien TJ; Institute of Biomedical Engineering, The University of Oxford, Oxford, United Kingdom.
  • Mocco J; Neurology, Calvary Healthcare Bethlehem, Parkdale, Australia.
  • Grayden DB; Department of Neurology, The University of Melbourne, The Royal Melbourne Hospital, Parkville, Australia.
  • Liebeskind DS; Department of Medicine, The University of Melbourne, The Royal Melbourne Hospital, Parkville, Australia.
  • Opie NL; Department of Neuroscience, The Central Clinical School, Monash University and Alfred Health, Melbourne, Australia.
  • Oxley TJ; Department of Neurosurgery, Klingenstein Clinical Center, The Mount Sinai Hospital, New York, New York.
  • Campbell BCV; Department of Biomedical Engineering, Faculty of Engineering and Information Technology, The University of Melbourne, Parkville, Australia.
JAMA Neurol ; 80(3): 270-278, 2023 03 01.
Article em En | MEDLINE | ID: mdl-36622685
ABSTRACT
Importance Brain-computer interface (BCI) implants have previously required craniotomy to deliver penetrating or surface electrodes to the brain. Whether a minimally invasive endovascular technique to deliver recording electrodes through the jugular vein to superior sagittal sinus is safe and feasible is unknown.

Objective:

To assess the safety of an endovascular BCI and feasibility of using the system to control a computer by thought. Design, Setting, and

Participants:

The Stentrode With Thought-Controlled Digital Switch (SWITCH) study, a single-center, prospective, first in-human study, evaluated 5 patients with severe bilateral upper-limb paralysis, with a follow-up of 12 months. From a referred sample, 4 patients with amyotrophic lateral sclerosis and 1 with primary lateral sclerosis met inclusion criteria and were enrolled in the study. Surgical procedures and follow-up visits were performed at the Royal Melbourne Hospital, Parkville, Australia. Training sessions were performed at patients' homes and at a university clinic. The study start date was May 27, 2019, and final follow-up was completed January 9, 2022.

Interventions:

Recording devices were delivered via catheter and connected to subcutaneous electronic units. Devices communicated wirelessly to an external device for personal computer control. Main Outcomes and

Measures:

The primary safety end point was device-related serious adverse events resulting in death or permanent increased disability. Secondary end points were blood vessel occlusion and device migration. Exploratory end points were signal fidelity and stability over 12 months, number of distinct commands created by neuronal activity, and use of system for digital device control.

Results:

Of 4 patients included in analyses, all were male, and the mean (SD) age was 61 (17) years. Patients with preserved motor cortex activity and suitable venous anatomy were implanted. Each completed 12-month follow-up with no serious adverse events and no vessel occlusion or device migration. Mean (SD) signal bandwidth was 233 (16) Hz and was stable throughout study in all 4 patients (SD range across all sessions, 7-32 Hz). At least 5 attempted movement types were decoded offline, and each patient successfully controlled a computer with the BCI. Conclusions and Relevance Endovascular access to the sensorimotor cortex is an alternative to placing BCI electrodes in or on the dura by open-brain surgery. These final safety and feasibility data from the first in-human SWITCH study indicate that it is possible to record neural signals from a blood vessel. The favorable safety profile could promote wider and more rapid translation of BCI to people with paralysis. Trial Registration ClinicalTrials.gov Identifier NCT03834857.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Interfaces Cérebro-Computador Tipo de estudo: Prognostic_studies Limite: Aged / Humans / Male / Middle aged Idioma: En Revista: JAMA Neurol Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Austrália

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Interfaces Cérebro-Computador Tipo de estudo: Prognostic_studies Limite: Aged / Humans / Male / Middle aged Idioma: En Revista: JAMA Neurol Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Austrália