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.
Chronic, medically stable lower limb amputation due to diabetes or insensate foot due to Diabetic peripheral neuropathy
Being ambulatory and ability to stand or walk with prosthesis or orthosis
Viable target nerves in the lower extremity as determined by standard-of-care clinical tests of nerve conduction, response to stimulation, sensory evoked potentials (SEP) and the like
Good skin integrity and personal hygiene
Active pressure ulcers or chronic skin ulcerations
Uncontrolled diabetes with HbA1c greater than or equal to 69 mmol/mol (8.5%)
Significant vascular disease
Significant history of poor wound healing
Single group
Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode
DeviceSee arm description
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.
Neuropathic Pain Syndrome Inventory (NPSI)
The NPSI is comprised of five subscales, each representing different dimensions of neuropathic pain: burning spontaneous pain (burning), pressing spontaneous pain (pressing), paroxysmal pain (paroxysmal), evoked pain (evoked), and paresthesia/dysesthesia Each area subscale is scored between 0-10. The scores are not combined, but are able to report on different aspects of neuropathic pain. A higher score indicates a worse outcome.
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VA Office of Research and Development
Lead sponsor
Case Western Reserve University
Collaborator
