Somatosensory Perception Following Lower Limb Amputation
Conditions
Keywords
Neuromodulation, Phantom pain, Amputation
Brief summary
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.
Interventions
DEVICE32 channel external stimulator
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.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) |
| 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 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) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
Outcome results
None listed