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Feasibility of Neural Feedback for Lower Limb Amputees

NCT03409133 · 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 lower limb loss, including above and below knee amputees. The approach involves delivering small electrical currents directly to remaining nerves via implanted stimulating electrodes. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how information about the foot and lower limb used to be transferred to your brain prior to the amputation.

Individuals also have the option to have recording electrodes implanted within muscles of the lower limb(s) in an attempt to develop a motor controller that would enable the user to have intuitive control of a robotic prosthetic leg.

Conditions

  • Amputation

Interventions

DEVICE

Stimulating nerve electrodes and intramuscular recording electrodes

See Arm Description

Sponsors & Collaborators

  • Case Western Reserve University

    collaborator OTHER

  • United States Department of Defense

    collaborator FED

  • Louis Stokes VA Medical Center

    lead FED

Principal Investigators

  • Ronald Triolo, PhD · Louis Stokes VA Medical Center

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
2015-11-05
Primary Completion
2027-09-01
Completion
2027-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03409133 on ClinicalTrials.gov