Challenges to clinical deployment of upper limb neuroprostheses

Area of Science:

• Biomedical Engineering
• Rehabilitation Technology
• Neuroscience

Background:

• Functional neuromuscular stimulation (FNS) has been developed for nearly two decades to restore upper limb function in individuals with tetraplegia.
• Three distinct FNS systems are currently undergoing clinical trials: a noninvasive splint-based system, a percutaneous system, and an implantable device.

Purpose of the Study:

• To present the current status of clinical trials for three different FNS systems.
• To identify and analyze emerging challenges for the widespread clinical introduction of FNS for hand and arm function.

Main Methods:

• Review of ongoing clinical trials for three FNS systems (noninvasive, percutaneous, implantable).
• Analysis of clinical and technical challenges associated with FNS system deployment.
• Examination of regulatory, educational, economic, and societal factors impacting FNS adoption.

Main Results:

• Three FNS systems are in clinical development, each with unique design and application characteristics.
• Significant clinical and technical hurdles must be surmounted before FNS devices can be widely deployed.
• Regulatory requirements, user knowledge, skepticism, and professional complacency present barriers to adoption.

Conclusions:

• Widespread clinical introduction of FNS systems requires addressing complex technical and clinical challenges.
• Overcoming user and professional skepticism through education and demonstrating economic/societal benefits is crucial.
• Successful FNS deployment necessitates a comprehensive approach considering technological, human, and systemic factors.