# Functional and Neuroprotective Effects of Restoring Lower Limb Sensation after Diabetic Peripheral Neuropathy

> **NIH VA I01** · LOUIS STOKES CLEVELAND VA MEDICAL CENTER · 2022 · —

## Abstract

Thus project addresses a gap in the available interventions for Veterans with Diabetic
Peripheral Neuropathy (DPN), a large and growing chronic disease population within the VHA.
Individuals with diabetes have a 10-times higher risk of amputations than the general
population. We expect that discrete, meaningful sensations perceived to be arising from the
missing foot can be chronically elicited by multi-contact peripheral nerve cuff electrodes
installed on the nerves in the thigh above the knee of Veterans with lower-limb loss due to
DPN. We anticipate that these electrically elicited sensations can maintain the health and
resiliency of the residual limb and provide meaningful feedback during daily activities. We will
rigorously document medical and medication history, and the interactions of the ongoing
disease with the implanted components, and expect them to be well tolerated by volunteers
with minimal clinical complications.
 Amputees pay less attention to their feet, are at risk for complications affecting the skin and
underlying tissues of their residual limb due to routine prosthetic socket use. We expect that
eliciting sensation perceived as arising from the missing foot via neural stimulation will improve
the health of the residual limb tissues of Veterans with limb loss due to DPN, and make them
more resilient to potentially damaging loads. That is, circulation and residual limb tissue health
will improve, and the likelihood of developing complications will decrease with the restoration
of appropriate sensation. Therefore, physiological measures of blood flow, temperature,
transcutaneous oxygen and other indicators of underlying tissue health, as well as the and
frequency and severity of phantom pain will change as a result of this unique intervention.
 The sensations perceived as related to physical interactions of the prosthesis with the
environment elicited with neural stimulation will also improve standing balance, walking
mechanics, and overall confidence and activity levels of Veterans with lower-limb loss due to
DPN. Standing balance and sway, and the ability to adapt to challenging or changing
environments, as well as subjective assessments of attention, balance confidence and fear of
falling measured with and without sensory stimulation. We further anticipate that recipients of
our Sensory Neuroprosthesis who have DPN will find it valuable in the home and community
as evidenced by patterns of usage, total standing and walking time, and subjective ratings of
satisfaction and effort. We expect users to have increased mobility, and cope more effectively
with disturbances to gait and balance.
 We will recruit and enroll a total of five new participants who will receive the surgically
implanted systems, and act as their own historical (pre- and post-implantation) and concurrent
(with and without sensory stimulation) controls. The Sensory Neuroprosthesis previously
developed by our group for traumatic trans-tibial amputees consisting...

## Key facts

- **NIH application ID:** 10390351
- **Project number:** 5I01RX003566-02
- **Recipient organization:** LOUIS STOKES CLEVELAND VA MEDICAL CENTER
- **Principal Investigator:** RONALD J TRIOLO
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2022
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2021-04-01 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10390351

## Citation

> US National Institutes of Health, RePORTER application 10390351, Functional and Neuroprotective Effects of Restoring Lower Limb Sensation after Diabetic Peripheral Neuropathy (5I01RX003566-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10390351. Licensed CC0.

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