The purpose of this study is to investigate how leg amputee patients can feel sensations with neuromodulation while they are using a prosthetic leg. "Neuromodulation" is the process by which the nervous system can be regulated by targeted delivery of a stimulus, such as electrical stimulation or chemical agents, to specific neurological sites in the body. In this study, the investigators plan to use either electrical stimulation of the spinal cord (Spinal Cord Stimulation) or electrical stimulation of the dorsal root ganglion (DRG stimulation) as methods for neuromodulation. Participation in this study will involve visiting the K-Lab (Human Performance Laboratory) at Duke's Sports Medicine Institute once prior to trial implant surgery, if feasible, and four times during the two weeks following the implantation of trial stimulation leads to evaluate sensations related to touch and position of the prosthetic leg as they are generated by neuromodulation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Patients will be stimulated by the 32 channel external stimulator via leads placed as part of standard care neuromodulation. Then patients will undergo various tasks.
Change in stimulation as reported by patients
Time frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Change in stimulation parameters as measured by frequency
Time frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Change in stimulation parameters as measured by pulse width
Time frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Change in stimulation parameters as measured by amplitude
Time frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Change in pain score as measured by McGill Pain Questionnaire
Time frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Change in gait parameters as measured by step frequency
Time frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Change in passive movement detection as measured by external sensors
Time frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Change in cortical reorganization measured by Electroencephalogram (EEG)
Time frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
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