MedTrace Logo

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

NCT04658693 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-03-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with above and below the knee limb loss. The investigators will implanted stimulating electrodes to send small electrical currents to the remaining nerves. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how the information about your foot and lower limb used to be transferred to the brain prior to your limb loss. Additionally, there is the option to have muscle recording electrodes implanted within the muscles of the lower limb with the goal to develop a motor controller that would allow the user to have intuitive control of a robotic prosthetic leg.

Conditions

  • Lower Extremity Amputee
  • Diabetic Peripheral Neuropathy

Interventions

DEVICE

Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode

See arm description

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Ronald Triolo, PhD · Louis Stokes VA Medical Center, Cleveland, OH

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2027-09-02
Completion
2027-09-02
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04658693 on ClinicalTrials.gov