Abstract
Endovascular neuromodulation is an emerging technology that represents a synthesis between interventional neurology and neural engineering. The prototypical endovascular neural interface is the StentrodeTM, 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 StentrodeTM 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 StentrodeTM, 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 StentrodeTM and define avenues where further research and development are necessary in order to optimize this device for human application.
Highlights
Intracranial neuromodulation has numerous potential applications, including epilepsy monitoring [1, 2], neurostimulation [3], thought to text and thought to speech paradigms [4,5,6], and control of robotic limbs and exoskeletons [7]
The intracranial venous system represents a promising conduit for neuromodulation devices
The original application of the Solitaire stent was for endovascular clot retrieval in the setting of ischaemic stroke [77]
Summary
Intracranial neuromodulation has numerous potential applications, including epilepsy monitoring [1, 2], neurostimulation [3], thought to text and thought to speech paradigms [4,5,6], and control of robotic limbs and exoskeletons [7]. Whilst the StentrodeTM’s endovascular delivery confers greater ease of implantation, it relies on the transmission of signals through a permanent transvenous lead Possible complications of this device include stent- or lead-associated venous thrombosis, device-related infection and lead failure [14]. The SSS in sheep was chosen as an initial target primarily because of its ease of access through catheter venography and its parallel orientation to the ovine motor area It has a diameter of 1.2 to 2.4 mm [37], which is comparable to the diameter of the human CSV (2.3 to 4.9 mm) [14]. It is not possible to train sheep to perform complex motor tasks, making it difficult to assess the utility of the StentrodeTM as a closed loop brain machine interface in an ovine model These limitations highlight the necessity of a human trial of the StentrodeTM. Major neurological complications, such as in-stent thrombosis and subdural,
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