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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
Stimulating nerve electrodes and intramuscular recording electrodes
DeviceSee Arm Description
Treatment groups
Trial outcomes
Primary outcomes
Stimulation Thresholds
Quantify the minimum stimulation required to evoke electrically induced sensations on the phantom limb.
Functional Gait Assessment (FGA)
The Functional Gait Assessment is a 10 task test that measures postural stability. Each task is scored from 0 -3 with 0 indicating severe impairment in the task and 3 indicating normal ambulation. The scores are combined to give a total score. The maximum score is 30. A higher score indicates a better outcome.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Louis Stokes VA Medical Center
Lead sponsor
Case Western Reserve University
Collaborator
United States Department of Defense
Collaborator