Risk-benefit value of upper extremity function by an implanted electrical stimulation device targeting chronic...

Area of Science:

• Neuroscience and Biomedical Engineering
• Rehabilitation Medicine
• Patient-Reported Outcomes Research

Background:

• The Networked Neuroprosthesis (NNP) aims to restore upper extremity function in individuals with tetraplegia.
• Understanding patient preferences for functional outcomes and risk tolerance is crucial for clinical trial design.

Purpose of the Study:

• To assess the relative importance of various arm and hand functions for individuals with tetraplegia.
• To determine patient tolerance for the adverse event profile associated with neuroprosthetic devices.
• To inform the design of a pivotal trial for the upper extremity configuration of the NNP.

Main Methods:

• A cross-sectional, stated-preference online survey was administered to adults living with tetraplegia.
• Direct-assessment questions and a 7-point Likert scale were used to gauge participant agreement with statements on benefits and risks.
• Chi-squared analyses explored associations between responses and demographic/injury characteristics.

Main Results:

• Over 70% of participants rated regaining arm/hand function as "very important."
• Participants expressed variable concern regarding surgical risks, with increasing concern for risks in the first 5 years post-implantation.
• More than 64% of responders were interested in the NNP, even with a 50% success rate threshold, irrespective of injury duration.

Conclusions:

• Individuals with tetraplegia demonstrate a strong desire for improved arm and hand function.
• There is a notable tolerance for the risks associated with implanted neuroprosthetic devices.
• Findings support the potential for neuroprosthetic interventions like the NNP in this population.