Spinal Cord Stimulation (SCS) for Amputees

Study Overview
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Brief Summary
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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.

Official Title
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Evaluate Tactile Sensation and Proprioception in Lower Limb Amputees Using Neuromodulation

Conditions
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Somatosensory Perception Following Lower Limb Amputation

Intervention / Treatment
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* Device: 32 channel external stimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 18 years of age Subject is able and willing to comply with the schedule and protocol Subject is a lower limb amputee who uses a prosthetic leg Subject is a good candidate for implantation of a stimulator for their amputation related pain Subject has stable neurological/cognitive function in the past 30 days Subject is able to provide informed consent Exclusion Criteria: Subject is currently participating in a clinical investigation that includes an active treatment arm Subject currently has an active implantable device including an Implantable Cardioverter Defibrillator (ICD), pacemaker, spinal cord stimulator, or intrathecal drug pump Subject is a prisoner Female subject whom are pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients undergoing Neuromodulation<br>Patients, who have had a lower limb amputation and undergoing neuromodulation as part of standard of care. | Device: 32 channel external stimulator<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromodulation, Phantom pain, Amputation