Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System.
Journal
Neurology
ISSN: 1526-632X
Titre abrégé: Neurology
Pays: United States
ID NLM: 0401060
Informations de publication
Date de publication:
14 03 2023
14 03 2023
Historique:
received:
05
02
2022
accepted:
03
11
2022
pubmed:
14
1
2023
medline:
16
3
2023
entrez:
13
1
2023
Statut:
ppublish
Résumé
Brain-computer interfaces (BCIs) are being developed to restore mobility, communication, and functional independence to people with paralysis. Though supported by decades of preclinical data, the safety of chronically implanted microelectrode array BCIs in humans is unknown. We report safety results from the prospective, open-label, nonrandomized BrainGate feasibility study (NCT00912041), the largest and longest-running clinical trial of an implanted BCI. Adults aged 18-75 years with quadriparesis from spinal cord injury, brainstem stroke, or motor neuron disease were enrolled through 7 clinical sites in the United States. Participants underwent surgical implantation of 1 or 2 microelectrode arrays in the motor cortex of the dominant cerebral hemisphere. The primary safety outcome was device-related serious adverse events (SAEs) requiring device explantation or resulting in death or permanently increased disability during the 1-year postimplant evaluation period. The secondary outcomes included the type and frequency of other adverse events and the feasibility of the BrainGate system for controlling a computer or other assistive technologies. From 2004 to 2021, 14 adults enrolled in the BrainGate trial had devices surgically implanted. The average duration of device implantation was 872 days, yielding 12,203 days of safety experience. There were 68 device-related adverse events, including 6 device-related SAEs. The most common device-related adverse event was skin irritation around the percutaneous pedestal. There were no safety events that required device explantation, no unanticipated adverse device events, no intracranial infections, and no participant deaths or adverse events resulting in permanently increased disability related to the investigational device. The BrainGate Neural Interface system has a safety record comparable with other chronically implanted medical devices. Given rapid recent advances in this technology and continued performance gains, these data suggest a favorable risk/benefit ratio in appropriately selected individuals to support ongoing research and development. ClinicalTrials.gov Identifier: NCT00912041. This study provides Class IV evidence that the neurosurgically placed BrainGate Neural Interface system is associated with a low rate of SAEs defined as those requiring device explantation, resulting in death, or resulting in permanently increased disability during the 1-year postimplant period.
Sections du résumé
BACKGROUND AND OBJECTIVES
Brain-computer interfaces (BCIs) are being developed to restore mobility, communication, and functional independence to people with paralysis. Though supported by decades of preclinical data, the safety of chronically implanted microelectrode array BCIs in humans is unknown. We report safety results from the prospective, open-label, nonrandomized BrainGate feasibility study (NCT00912041), the largest and longest-running clinical trial of an implanted BCI.
METHODS
Adults aged 18-75 years with quadriparesis from spinal cord injury, brainstem stroke, or motor neuron disease were enrolled through 7 clinical sites in the United States. Participants underwent surgical implantation of 1 or 2 microelectrode arrays in the motor cortex of the dominant cerebral hemisphere. The primary safety outcome was device-related serious adverse events (SAEs) requiring device explantation or resulting in death or permanently increased disability during the 1-year postimplant evaluation period. The secondary outcomes included the type and frequency of other adverse events and the feasibility of the BrainGate system for controlling a computer or other assistive technologies.
RESULTS
From 2004 to 2021, 14 adults enrolled in the BrainGate trial had devices surgically implanted. The average duration of device implantation was 872 days, yielding 12,203 days of safety experience. There were 68 device-related adverse events, including 6 device-related SAEs. The most common device-related adverse event was skin irritation around the percutaneous pedestal. There were no safety events that required device explantation, no unanticipated adverse device events, no intracranial infections, and no participant deaths or adverse events resulting in permanently increased disability related to the investigational device.
DISCUSSION
The BrainGate Neural Interface system has a safety record comparable with other chronically implanted medical devices. Given rapid recent advances in this technology and continued performance gains, these data suggest a favorable risk/benefit ratio in appropriately selected individuals to support ongoing research and development.
TRIAL REGISTRATION INFORMATION
ClinicalTrials.gov Identifier: NCT00912041.
CLASSIFICATION OF EVIDENCE
This study provides Class IV evidence that the neurosurgically placed BrainGate Neural Interface system is associated with a low rate of SAEs defined as those requiring device explantation, resulting in death, or resulting in permanently increased disability during the 1-year postimplant period.
Identifiants
pubmed: 36639237
pii: WNL.0000000000201707
doi: 10.1212/WNL.0000000000201707
pmc: PMC10074470
doi:
Banques de données
ClinicalTrials.gov
['NCT00912041']
Types de publication
Clinical Trial
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
e1177-e1192Subventions
Organisme : NINDS NIH HHS
ID : R01 NS062092
Pays : United States
Organisme : NICHD NIH HHS
ID : N01HD53403
Pays : United States
Organisme : RRD VA
ID : I50 RX002864
Pays : United States
Organisme : NIDCD NIH HHS
ID : R01 DC009899
Pays : United States
Organisme : NICHD NIH HHS
ID : R01 HD077220
Pays : United States
Organisme : Howard Hughes Medical Institute
Pays : United States
Organisme : NIDCD NIH HHS
ID : R01 DC014034
Pays : United States
Organisme : RRD VA
ID : I01 RX002295
Pays : United States
Organisme : NINDS NIH HHS
ID : U01 NS098968
Pays : United States
Organisme : NIDCD NIH HHS
ID : U01 DC017844
Pays : United States
Organisme : NINDS NIH HHS
ID : UH2 NS095548
Pays : United States
Organisme : NINDS NIH HHS
ID : R25 NS065743
Pays : United States
Informations de copyright
Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.
Références
Neurorehabil Neural Repair. 2015 Jun;29(5):462-71
pubmed: 25385765
Lancet. 2017 May 6;389(10081):1821-1830
pubmed: 28363483
World Neurosurg. 2010 Apr;73(4):338-44
pubmed: 20849789
J Neural Eng. 2016 Aug;13(4):046019
pubmed: 27351722
Stereotact Funct Neurosurg. 2011;89(2):89-95
pubmed: 21293168
Front Neurol. 2018 Jul 27;9:603
pubmed: 30100896
Nature. 2021 May;593(7858):249-254
pubmed: 33981047
Elife. 2017 Feb 21;6:
pubmed: 28220753
J Neural Eng. 2013 Dec;10(6):066014
pubmed: 24216311
Stereotact Funct Neurosurg. 2016;94(3):187-97
pubmed: 27434073
Neuromodulation. 2020 Jun;23(4):411-426
pubmed: 31747103
IEEE Trans Biomed Eng. 2021 Jul;68(7):2313-2325
pubmed: 33784612
Nature. 2006 Jul 13;442(7099):164-71
pubmed: 16838014
Neural Plast. 2020 Aug 1;2020:2486065
pubmed: 32802034
Lancet. 2013 Feb 16;381(9866):557-64
pubmed: 23253623
Nat Med. 2021 Oct;27(10):1696-1700
pubmed: 34608328
J Neurosci Methods. 1998 Jul 1;82(1):1-15
pubmed: 10223510
World Neurosurg. 2015 Sep;84(3):719-26
pubmed: 25940211
J Neural Eng. 2018 Apr;15(2):026007
pubmed: 29363625
Science. 2021 May 21;372(6544):831-836
pubmed: 34016775
J Neurosurg. 2003 Apr;98(4):779-84
pubmed: 12691402
Neurosurg Focus. 2020 Jul;49(1):E3
pubmed: 32610291
Front Bioeng Biotechnol. 2021 Dec 07;9:759711
pubmed: 34950640
N Engl J Med. 2016 Nov 24;375(21):2060-2066
pubmed: 27959736
Nature. 2016 Apr 13;533(7602):247-50
pubmed: 27074513
Neurosurgery. 2020 Feb 1;86(2):E108-E117
pubmed: 31361011
J Neurointerv Surg. 2021 Feb;13(2):102-108
pubmed: 33115813
IEEE Trans Neural Syst Rehabil Eng. 2005 Dec;13(4):524-41
pubmed: 16425835
J Neural Eng. 2011 Apr;8(2):025027
pubmed: 21436513
Nat Commun. 2022 Mar 22;13(1):1236
pubmed: 35318316
Neurology. 2014 May 27;82(21):1852-3
pubmed: 24789868
Nature. 2012 May 16;485(7398):372-5
pubmed: 22596161
Acta Neurochir (Wien). 2007;149(9):867-75; discussion 876
pubmed: 17690838
N Engl J Med. 2011 May 26;364(21):2016-25
pubmed: 21612470
Brain Commun. 2021 Oct 21;3(4):fcab248
pubmed: 34870202
Neurology. 2004 Aug 24;63(4):612-6
pubmed: 15326230
Nature. 2022 Aug;608(7924):S46-S47
pubmed: 36002493
World Neurosurg. 2013 Mar-Apr;79(3-4):457-71
pubmed: 23333985
Front Neurosci. 2018 Apr 04;12:208
pubmed: 29670506
IEEE Trans Rehabil Eng. 1999 Mar;7(1):56-68
pubmed: 10188608
J Neurol Sci. 2009 Feb 15;277(1-2):26-31
pubmed: 19013586
N Engl J Med. 2021 Jul 15;385(3):217-227
pubmed: 34260835
Neurology. 2020 Sep 1;95(9):e1244-e1256
pubmed: 32690786
IEEE Trans Neural Syst Rehabil Eng. 2017 Oct;25(10):1687-1696
pubmed: 28278476
Acta Neurochir (Wien). 2022 Sep;164(9):2299-2302
pubmed: 35604492