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Funding
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing Neuromodulation | Experimental | Patients, who have had a lower limb amputation and undergoing neuromodulation as part of standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 32 channel external stimulator | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in stimulation as reported by patients | 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 | 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 | 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 | 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 | Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gait parameters as measured by step frequency | 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 | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nandan Lad, MD | Duke University | Principal Investigator |
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| ID | Term |
|---|---|
| D010591 | Phantom Limb |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Change in cortical reorganization measured by Electroencephalogram (EEG) | Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours) |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010146 | Pain |