Clinical Trial

Feasibility of Neural Feedback for Lower Limb Amputees

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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2018-01-17; most recent amendment 2026-03-04.
Trial Details
NCT Number NCT03409133
Lead Sponsor Louis Stokes VA Medical Center
Collaborators: Case Western Reserve University, United States Department of Defense
Conditions Amputation
Enrollment 15 participants
Start Date 2015-11-05
Primary Completion 2027-09-01 (estimated)
Study Completion 2027-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-06