About this trial
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.
Eligibility criteria
Qualifiers
Adults age 18 or greater
Chronic, medically stable ( > 3 months) trans-tibial or trans-femoral amputation at the time of implant surgery.
Potential user of trans-tibial or trans-femoral prostheses for standing or walking
Viable target nerves in the lower extremity as determined by standard-of-care clinical tests of nerve conduction, response to stimulation, sensory evoked potentials and the like
Disqualifiers
Uncontrolled diabetes to a degree that would preclude surgery
Significant vascular disease
Chronic skin ulcerations
Significant history of poor wound healing
Trial design
Treatments tested in this trial
- Stimulating nerve electrodes and intramuscular recording electrodes
Treatment groups
Sponsors and collaborators
Louis Stokes VA Medical Center
Lead sponsor
Case Western Reserve University
Collaborator
United States Department of Defense
Collaborator