Spinal Cord Injury (SCI) is characterized by a disruption of the spinal pathways connecting the brain to the rest of the body. This can result in an impairment or complete loss of sensory and/or motor functions, depending on the level and severity of the injury. The most common approach of attempting motor recovery using neuromodulation has been through epidural spinal cord electrical stimulation (eSCS), with or without rehabilitation and robotic assistance¹ , ². Dorsal Root Ganglion (DRG) stimulation is a relatively new neuromodulation treatment, which has already been established as a safe and effective treatment for chronic pain. However, its application for motor recovery after SCI has remained unexplored territory. A recent study by Soloukey et al.³ showed the first promising results using L4-level DRG-stimulation to evoke strong and reproducible motor responses in the upper leg muscles of patients with motor complete SCI. The current work presents the development of a prototype stimulator intended for use in early clinical trials for the purpose of further exploring the effects of multi-level DRG-stimulation on motor recovery after SCI. The prototype stimulator is created using commercially available components, focussing primarily on the safety considerations for the use of the prototype in a clinical research environment. The prototype allows for access to multiple leads in parallel to facilitate faster, sequential stimulation, catering for a maximum of 16 leads at once. The final system is equipped with a microcontroller for the programming of the stimulation parameters, a Bluetooth module for the communication with external components (Graphical User Interface (GUI) on a local PC) and tailored connections to the stimulating DRG-leads. The safety and well-being of the patient is set as a first priority, leading to a tailored design and development of the stimulator accordingly. Parameters like the patient's comfort when connected to the device, the safety of the patient and the medical personnel with regards to powering the device through the mains, and protection from any current or DC voltage leakage, are discussed. The prototype is currently undergoing safety evaluation and the complete system design together with these results will be presented during the conference.@en

This paper presents the development of a Dorsal Root Ganglion (DRG) stimulator system intended for use in early clinical trials for motor recovery after Spinal Cord Injury (SCI). It allows for independent control of multisite/multilevel bilateral (on both sides of the spinal cord) stimulation, it can supply a high output current of 25.4mA, and has the ability to program pulse sequences similar to actual locomotion patterns. These characteristics ultimately provide the required versatility for examining the effects of DRG stimulation on locomotion recovery, which is lacking in currently available commercial systems. The device is created using commercially available components to make the design reproducible by other research labs and to facilitate the critical approval procedure for use in a clinical research environment. Throughout the design phase, essential considerations regarding the safety of the participating patient, as well as of the medical personnel involved, were taken into account and these are analyzed and demonstrated in this paper. Such considerations are very rarely discussed in scientific literature and the authors consider that, apart from the design of the system itself, this discussion is a critical contribution of this paper.

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Background and Purpose: Oncological neurosurgery relies heavily on making continuous, intra-operative tumor-brain delineations based on image-guidance. Limitations of currently available imaging techniques call for the development of real-time image-guided resection tools, which allow for reliable functional and anatomical information in an intra-operative setting. Functional ultrasound (fUS), is a new mobile neuro-imaging tool with unprecedented spatiotemporal resolution, which allows for the detection of small changes in blood dynamics that reflect changes in metabolic activity of activated neurons through neurovascular coupling. We have applied fUS during conventional awake brain surgery to determine its clinical potential for both intra-operative functional and vascular brain mapping, with the ultimate aim of achieving maximum safe tumor resection. Methods: During awake brain surgery, fUS was used to image tumor vasculature and task-evoked brain activation with electrocortical stimulation mapping (ESM) as a gold standard. For functional imaging, patients were presented with motor, language or visual tasks, while the probe was placed over (ESM-defined) functional brain areas. For tumor vascular imaging, tumor tissue (pre-resection) and tumor resection cavity (post-resection) were imaged by moving the hand-held probe along a continuous trajectory over the regions of interest. Results: A total of 10 patients were included, with predominantly intra-parenchymal frontal and temporal lobe tumors of both low and higher histopathological grades. fUS was able to detect (ESM-defined) functional areas deep inside the brain for a range of functional tasks including language processing. Brain tissue could be imaged at a spatial and temporal resolution of 300 μm and 1.5–2.0 ms respectively, revealing real-time tumor-specific, and healthy vascular characteristics. Conclusion: The current study presents the potential of applying fUS during awake brain surgery. We illustrate the relevance of fUS for awake brain surgery based on its ability to capture both task-evoked functional cortical responses as well as differences in vascular characteristics between tumor and healthy tissue. As current neurosurgical practice is still pre-dominantly leaning on inherently limited pre-operative imaging techniques for tumor resection-guidance, fUS enters the scene as a promising alternative that is both anatomically and physiologically informative.

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