Adults 22 to 70, any sex, with Traumatic Amputation of Lower Extremity or Phantom Limb Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Experiencing Serious Device-related Adverse Events up to 90 Days Following ImplantationPrimary· 90 days
Investigators will track the number of participants experiencing serious device-related adverse events, such as unresolved superficial infection resulting in lead removal, deep infection, inpatient hospitalization, withdrawal from the study due to worsening pain or intolerable dysesthesia, or fracture due to falls related to the study interventions, that occur during the course of and up to 90 days following implantation.
Group
Value
95% CI
Spinal cord stimulation
0
Minimum Amplitude of Pulse Required to Evoke Sensory PerceptsPrimary· 90 days
Quantify the threshold stimulus required to evoke sensory percepts during epidural spinal nerve stimulation.
Group
Value
95% CI
Spinal Cord Stimulation
2
Minimum Charge Required to Evoke a Neurophysiological ResponsePrimary· 90 days
Quantify the threshold (minimum charge) stimulus required to evoke neurophysiological responses during epidural spinal nerve stimulation
Group
Value
95% CI
Spinal cord stimulation
1.23
Location of Evoked Sensation - Missing ToesPrimary· 90 days
Participants reporting sensation on missing toes from spinal cord stimulation.
Group
Value
95% CI
Spinal Cord Stimulation
1
Location of Evoked Sensation - Plantar Surface of Missing FootPrimary· 90 days
Participants perceiving sensation on the plantar surface of missing foot
Group
Value
95% CI
Spinal Cord Stimulation
1
Change in Phantom Limb Pain Using the McGill Pain QuestionnaireSecondary· Pre-implant (baseline), Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and post-explant (90 days)
The McGill Pain Questionnaire is a questionnaire used to evaluate the severity of pain experienced by the participant. The questionnaire is scaled, with a minimum and maximum pain score of 0 and 78, respectively. The higher the score on the questionnaire, the more intense the pain felt by the participant. A lower score than previously reported represents a decrease in experienced phantom limb pain.
Before placement of the spinal cord stimulator leads, investigators will document the subject's description of their history of perceived phantom limb. Investigators will ask them to periodically u
Pre-implant (baseline)
Group
Value
95% CI
Spinal Cord Stimulation
48
Week 1 (after implant)
Group
Value
95% CI
Spinal Cord Stimulation
32
Week 2
Group
Value
95% CI
Spinal Cord Stimulation
45
Week 3
Group
Value
95% CI
Spinal Cord Stimulation
45
Week 4
Group
Value
95% CI
Spinal Cord Stimulation
23
Week 5
Group
Value
95% CI
Spinal Cord Stimulation
38
Week 6
Group
Value
95% CI
Spinal Cord Stimulation
32
Week 7
Group
Value
95% CI
Spinal Cord Stimulation
34
Qualitative Self-report of Evoked SensationsSecondary· 90 days
Document the subjective perception of lumbosacral epidural spinal nerve stimulation for restoration of sensation. The investigators will ask each subject to provide subjective feedback on their perceived utility of the sensory feedback provided by the device. A total of 13 natural descriptors and 5 paresthetic descriptors were presented to participants weekly to describe the sensation provided via spinal cord stimulation. The goal of the study is to elicit more natural than paresthetic descriptors from participants.
Natural: pressure, tickle, flutter, warm, sharp, prick, cool, pulsing, vibrat
Group
Value
95% CI
Spinal Cord Stimulation
1
Spinal Cord Stimulation
0
Able to Use a Prosthetic Limb With Neural SignalsSecondary· 90 days
Investigators will test the subject's success rate during control of prosthetic limb with and without sensory feedback provided by electrical stimulation of the spinal roots. Using either a virtual prosthetic limb or an instrumented prosthesis, stimulation of the spinal roots will be modulated based on signals recorded from the limb.
Group
Value
95% CI
Spinal Cord Stimulation
1
Adverse events — posted to ClinicalTrials.gov
Time frame: 90 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The goals of this study are to provide sensory information to amputees and reduce phantom limb pain via electrical stimulation of the lumbar spinal cord and spinal nerves. The spinal nerves convey sensory information from peripheral nerves to higher order centers in the brain. These structures still remain intact after amputation and electrical stimulation of the dorsal spinal nerves in individuals with intact limbs and amputees has been demonstrated to generate paresthetic sensory percepts referred to portions of the distal limb. Further, there is recent evidence that careful modulation of stimulation parameters can convert paresthetic sensations to more naturalistic ones when stimulating peripheral nerves in amputees. However, it is currently unclear whether it is possible to achieve this same conversion when stimulating the spinal nerves, and if those naturalistic sensations can have positive effects on phantom limb pain. As a first step towards those goals, in this study, the investigators will quantify the sensations generated by electrical stimulation of the spinal nerves, study the relationship between stimulation parameters and the quality of those sensations, measure changes in control of a prosthesis with sensory stimulation, and quantify the effects of that stimulation on the perception of the phantom limb and any associated pain.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lee Fisher, PhD
Last refreshed: 7 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04547582.