# Peripheral Interfaces in Amputees for Sensorimotor Integration

> **NIH VA I01** · LOUIS STOKES CLEVELAND VA MEDICAL CENTER · 2024 · —

## Abstract

Veterans who have lost an upper extremity in service of country have lost both hand function and the sense
of touch. Losing these primary sources of physical, manipulative, and emotional connection to the world
results in lifelong functional and social deficits. To restore the emotional and functional aspects of the hand to
a veteran, we have developed an implanted system of nerve electrodes to restore touch and sense of movement
and intramuscular electrodes to provide intuitive, long-term, stable control of prostheses with the look and
functions of a human hand. We have successfully deployed these electrode interfaces in four subjects for more
than six years without significant adverse events. Several case-series studies in-lab demonstrate multiple
important aspects of sensory restoration and prosthesis control. A five-week, in-home case series demonstrated
significant advantages to restoring sensation with even a one degree-of-freedom prosthesis. Beyond the
traditional prostheses, the new system has been connected to an advanced, human hand-like hand that has
sensors at nine locations to be used with the sensory feedback to the user and has individual motion of the
index finger, thumb, wrist, and middle through ring finger as a single group.
 The initial trials implemented wires through the skin as connection to the interfaces, but now we have
completed development of a fully-implanted, BluetoothLE™connected system to eliminate these connections.
The next step required to move this new technology towards making the treatment available to veterans is a larger, pilot
randomized clinical trial (RCT) comparing an advanced prosthesis treatment with implanted nerve and muscles interfaces
to traditional, state-of-art, clinically-prescribed prosthesis treatment. The implanted system with sensory feedback
and high degree-of-freedom control is expected to improve the subjects’ outcomes over currently-available
options. The results of this pilot trial will establish the viability and importance of the advanced prostheses and
will support a subsequent pivotal trial.
 The study has two aims. Aim 1 will determine the functional outcomes, social outcomes, and usage of an
advanced prostheses with implanted electrodes compared to the subject’s clinically prescribed, state-of-
art prosthesis treatment. Eight subjects will participate in a randomized, 2 x 2 cross-over study comparing
the new human hand-like prosthesis with implanted interfaces to the subject’s commercial prosthesis. Our
primary hypothesis is that within subject differences of the Othortics and Prosthetics User Survey - Quality of
Life (OPUS-QOL) measure will show significant improvement with the advanced prosthesis system. We will
collect weekly surveys for psychosocial outcomes and log device usage when subjects are at home. Subjects
will come to the lab monthly for functional tests and a larger range of surveys to understand the explore the
impact of the prosthesis on the subject’s daily life. ...

## Key facts

- **NIH application ID:** 10709573
- **Project number:** 5I01RX003355-04
- **Recipient organization:** LOUIS STOKES CLEVELAND VA MEDICAL CENTER
- **Principal Investigator:** DUSTIN J. TYLER
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2024
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2020-08-01 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10709573

## Citation

> US National Institutes of Health, RePORTER application 10709573, Peripheral Interfaces in Amputees for Sensorimotor Integration (5I01RX003355-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10709573. Licensed CC0.

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