Exploratory trial of the restores (revolutionary electrical stimulation technology to optimize recovery of everyone with spinal cord injury) system - spinal cord injury (SCI) has devastating impacts…

The National Institute of Neurological Disorders and Stroke awarded a cooperative agreement to Case Western Reserve University for $1,202,540 on September 1, 2026, to conduct an exploratory trial of the RESTORES (Revolutionary Electrical Stimulation Technology to Optimize Recovery of Everyone with Spinal Cord Injury) system.

The recipient will customize and program open-source Networked Neuroprosthesis (NNP) components—a modular peripheral neurostimulation device designed to address multiple functional impairments simultaneously in spinal cord injury patients—complete benchtop and regulatory testing of the system, submit an Investigational Device Exemption (IDE) for implantation, and conduct a pilot feasibility clinical trial. The NNP targets restoration or improvement of upper limb function, trunk stability, bladder and bowel control, and cardiovascular health in individuals with spinal cord injury through personalized, multi-channel stimulation tailored to each patient's specific functional needs.

Performance occurs in Cleveland, Ohio, with work concluding on July 31, 2029. This award falls under NINDS's Extramural Research Programs in the Neurosciences and Neurological Disorders (CFDA 93.853), which supports fundamental research into brain and nervous system structure and function and applied research to reduce the burden of neurological disease.

Exploratory trial of the restores (revolutionary electrical stimulation technology to optimize recovery of everyone with spinal cord injury) system - spinal cord injury (SCI) has devastating impacts on health, independence, dignity, and quality of life. IT can result in significant impairment or loss of functions, including paralysis in the upper and lower limbs, trunk instability, bladder/bowel dysfunction, and autonomic or cardiovascular dysfunction. There are few interventions to address an individual's multiple challenges of health and daily living. In addition to physical rehabilitation and assistive devices, neurostimulation (including both central neuromodulation and peripheral neurostimulation approaches) has shown great promise for improving or restoring upper limb function, trunk stability, bladder and bowel control, and cardiovascular health. One of the challenges with SCI is that no two individuals have the same injury or the same set of functional challenges. Central neuromodulation studies have generally focused on one or two functions at a time, and conventional peripheral neurostimulation devices often lack sufficient channels of stimulation to address multiple functions simultaneously. To advance a personalized medicine approach for improving multiple functions after SCI, we developed an open-source implantable, modular peripheral neurostimulation system - the networked neuroprosthesis (NNP). The NNP has the capability to improve or restore multiple functions that are compromised following SCI. The modular design of this system addresses this challenge directly by enabling a neurostimulation system to be tailored to the multiple needs of a given individual with SCI. In the UG3 phase, we will customize and program open-source NNP components to target multiple functions; complete benchtop and regulatory testing of the system; and submit an IDE for implantation of this system. Then, we will conduct a pilot feasibility clinical trial of this system in four individuals with cervical SCI, focusing on restoring upper limb, lower limb, ergometer exercise and bladder functions. This proposal is driven by the premise that technology has the potential to make a significant impact on individuals with SCI. Our team includes researchers who focus on SCI, clinicians who treat SCI, and individuals living with SCI. This technological approach is informed by this broad input of experience and expertise. If successful, we will have demonstrated a proof of concept of a system that addresses the most important challenges of individuals with SCI, improve quality of clinical care, and reduce overall costs and adverse impacts for the lifetime of the individual. Page 1