Focal stimulation of the sheep motor cortex with a chronically implanted minimally invasive electrode array mounted on an endovascular stent

Opie, Nicholas L.; John, Sam E.; Rind, Gil S.; Ronayne, Stephen M.; Wong, Yan T.; Gerboni, Giulia; Yoo, Peter E.; Lovell, Timothy John Haynes; Scordas, Theodore C.; Wilson, Stefan; Dornom, Anthony; Vale, Thomas R.; O’Brien, Terence J.; Grayden, David B.; May, Clive N.; Oxley, Thomas J.

doi:10.1038/s41551-018-0321-z

Cited by 87 publications

(90 citation statements)

References 61 publications

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“…For any novel biomedical device, rigorous animal testing is a necessary precursor to human trials. Whilst proof of concept for the Stentrode TM currently only exists in ovine models (14,15,23,37), these experiments provide important insights into the safety characteristics of the device.…”

Section: Ovine Studies Of the Stentrode Tmmentioning

confidence: 99%

“…In contrast, the recently developed Stentrode TM , which is permanently implanted into the superior sagittal sinus (SSS) via percutaneous catheter venography, is capable of long-term application (14). In an ovine model, this device demonstrated stable endovascular EEG recordings of sensorimotor cortex for up to 190 days, with equivalent fidelity to extradural and subdural ECoG electrodes (14, 23), as well as stimulation of discrete neuronal populations in sheep motor cortex, with comparable somatotopic accuracy to surgically implanted depth electrodes (15).…”

Section: Introductionmentioning

confidence: 96%

“…Furthermore, surgically implanted electrodes induce chronic inflammation at the electrode-tissue interface, leading to changes in electrical impedance and signal degradation over time (12,13). Endovascular neuromodulation may provide a minimally invasive solution that circumvents these issues whilst providing safe, accurate and long term recording, or stimulation of the brain (14,15).…”

Section: Introductionmentioning

confidence: 99%

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Endovascular Neuromodulation: Safety Profile and Future Directions

et al. 2020

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Endovascular neuromodulation is an emerging technology that represents a synthesis between interventional neurology and neural engineering. The prototypical endovascular neural interface is the Stentrode TM , a stent-electrode array which can be implanted into the superior sagittal sinus via percutaneous catheter venography, and transmits signals through a transvenous lead to a receiver located subcutaneously in the chest. Whilst the Stentrode TM has been conceptually validated in ovine models, questions remain about the long term viability and safety of this device in human recipients. Although technical precedence for venous sinus stenting already exists in the setting of idiopathic intracranial hypertension, long term implantation of a lead within the intracranial veins has never been previously achieved. Contrastingly, transvenous leads have been successfully employed for decades in the setting of implantable cardiac pacemakers and defibrillators. In the current absence of human data on the Stentrode TM , the literature on these structurally comparable devices provides valuable lessons that can be translated to the setting of endovascular neuromodulation. This review will explore this literature in order to understand the potential risks of the Stentrode TM and define avenues where further research and development are necessary in order to optimize this device for human application.

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Section: Ovine Studies Of the Stentrode Tmmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 99%

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Endovascular Neuromodulation: Safety Profile and Future Directions

et al. 2020

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“…The Stentrode TM is a miniaturized neural interface that can record and stimulate the brain from within a blood vessel [1,2]. The Stentrode TM derives its name from the amalgamation of its component partsstent plus electrodewhere the stent is used as a scaffold to support the electrodes (Figure 1).…”

Section: The Stentrode Tmmentioning

confidence: 99%

“…The Stentrode TM was also used to stimulate the motor cortex to generate gross movements [2]. Neuromodulation or stimulation of the brain has offered life-changing treatments for people with neurological conditions such as Parkinson's disease and epilepsy, usually by deep-brain stimulation.…”

Section: Stentrode Tm -Based Neuromodulationmentioning

confidence: 99%

The future potential of the Stentrode

John

Grayden

Yanagisawa

2019

Expert Review of Medical Devices

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Assessment of Safety of a Fully Implanted Endovascular Brain-Computer Interface for Severe Paralysis in 4 Patients

Mitchell

Lee

Yoo³

et al. 2023

JAMA Neurol

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ImportanceBrain-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.ObjectiveTo assess the safety of an endovascular BCI and feasibility of using the system to control a computer by thought.Design, Setting, and ParticipantsThe 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.InterventionsRecording 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 MeasuresThe 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.ResultsOf 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 RelevanceEndovascular 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 RegistrationClinicalTrials.gov Identifier: NCT03834857

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Focal stimulation of the sheep motor cortex with a chronically implanted minimally invasive electrode array mounted on an endovascular stent

Cited by 87 publications

References 61 publications

Endovascular Neuromodulation: Safety Profile and Future Directions

Endovascular Neuromodulation: Safety Profile and Future Directions

The future potential of the Stentrode

Assessment of Safety of a Fully Implanted Endovascular Brain-Computer Interface for Severe Paralysis in 4 Patients

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