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Spinal cord injury (SCI) profoundly affects health, independence, dignity, and quality of life. Individuals living with SCI often face significant challenges, including paralysis, trunk instability, bladder and bowel dysfunction, and cardiovascular complications. Despite advances in rehabilitation and assistive devices, few interventions address the complex, multifaceted needs of each person with SCI as no two injuries present identically or come with the exact same set of functional challenges.
Both central neuromodulation and peripheral neurostimulation approaches have shown promise in improving upper limb function, trunk stability, bladder and bowel control, and cardiovascular health. However, traditional devices often focus on one or two functions at a time and lack the flexibility to address multiple challenges simultaneously.
To advance a personalized medicine approach for improving multiple functions after SCI, an open-source implantable, modular peripheral neurostimulation system – the Networked Neuroprosthesis (NNP) - was developed. This innovative system is designed to be tailored to the unique needs of each individual with SCI, enabling personalized neurostimulation across multiple functions. The modular design directly addresses the variability of SCI, allowing clinicians to customize the system for each patient’s specific challenges.
In this project, entitled “Exploratory Trial of the RESTORES (Revolutionary Electrical Stimulation Technology to Optimize Recovery of Everyone with Spinal Cord Injury) System”, the research team will continue to advance this modular neurostimulation technology by accomplishing several major goals:
- Customizing and programing NNP components to target multiple functions.
- Completing benchtop and regulatory testing.
- Submitting an Investigational Device Exemption to the FDA for implantation.
- Conducting a pilot feasibility clinical trial of this system in four individuals with cervical SCI, focusing on restoring upper limb, lower limb, exercise, and bladder functions.
This work will demonstrate a proof of concept for a system that addresses the most important challenges faced by individuals with SCI by bringing together researchers, clinicians, and individuals with lived experience, ensuring that the system is informed by diverse expertise. The RESTORES system has the potential to improve clinical care, enhance quality of life, and reduce costs and adverse impacts over the lifetime of the individual.
This collaborative project team features rehabilitation research experts from the APT Center and across our partnering institutions. APTC Investigator Dr. Michael Fu will serve as one of the M-PIs on this project along with Drs. Dennis Bourbeau and Anne Bryden. Other APTC Investigator contributors include Dr. Nathan Makowski, Dr. Ron Triolo, Dr. Gilles Pinault, and Lisa Lombardo, MPT.
Congratulations to the entire RESTORES team on this incredible accomplishment!
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