N/A
N=4
Epidural Spinal Cord Stimulation for Sensory Restoration and Phantom Limb Pain in Upper-Limb Amputees
Phantom Limb
Bottom Line
View on ClinicalTrials.gov: NCT02684201 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Stimulation Thresholds to a Variety of Stimulus Parameters — 2.13 milliamps
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Boston Scientific Stimulator Lead (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lee Fisher, PhD
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stimulation Thresholds to a Variety of Stimulus Parameters |
2.13 | — |
| PRIMARY Week 1 Average Stimulus Charge for All Subjects |
647 | — |
| PRIMARY Week 2 Average Stimulus Charge for All Subjects |
807 | — |
| PRIMARY Week 3 Average Stimulus Charge for All Subjects |
1115 | — |
| PRIMARY Week 4 Average Stimulus Charge for All Subjects |
902 | — |
| SECONDARY Number of Participants Who Were Able to Discern Specific Regions of the Spinal Cord That Evoked Sensations |
4; 4; 3; 2; 4; 3 | — |
| SECONDARY Qualitative Self-report of Evoked Sensations |
1; 2; 1 | — |
| SECONDARY Change in Pain Ratings After Study Completion |
14.3; 32.3; 18 | — |
| SECONDARY Success Rate During Control of Prosthetic Hand to Identify Object Size |
74 | — |
| SECONDARY Success Rate During Control of Prosthetic Hand to Identify Object Compliance (Soft, Medium, Hard) |
60 | — |
Summary
Individuals with upper-limb amputation usually have intact nerves within the residual limb, and studies have demonstrated that electrical stimulation of those nerves can produce sensations that appear to emanate from the amputated limb. In this study, investigators will examine the sensations that are produced by electrical stimulation of these nerves at the location where they exit the spinal cord. Stimulation of the spinal cord is commonly used to treat intractable back and limb pain, and the procedure includes a test phase in which electrodes are temporarily placed under the skin near the spinal cord and removed at the end of testing. Similarly, in this study, electrodes will be placed near the spinal cord in the upper back and neck, and stimulation will be applied over the course of multiple testing sessions, lasting less than 30 days. The electrodes will be removed at the last day of testing. During each testing session, electrical stimulation will be applied through the electrodes and a series of tests will be performed to determine the types of sensations produced by stimulation. In addition to producing meaningful sensations with electrical stimulation, this study will also test the effect of stimulation on phantom limb sensations and phantom limb pain.
Eligibility Criteria
Inclusion Criteria
- have an upper-limb amputation
- must be between the ages of 18 and 70
- be at least one year post-amputation
- be willing to travel to the University of Pittsburgh at least twice per week for 29 days
Exclusion Criteria
- women who are pregnant or plan to become pregnant during the study
- all participants cannot have any serious diseases or disorders that affect your ability to participate in this study
- must not be currently taking any medications that thin your blood
Data sourced from ClinicalTrials.gov (NCT02684201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.