Traumatic Amputation of Lower ExtremitySCS-90NCT04547582
Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees, 90-Day
A study testing Spinal cord stimulator in people with Traumatic Amputation of Lower Extremity and Phantom Limb Pain, run by Lee Fisher, PhD at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Traumatic Amputation of Lower Extremity, Phantom Limb Pain
- What is being tested?
- Spinal cord stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2021to 3 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have an amputation of one lower limb, at a level between the ankle and knee joints. Minor amputation of the contralateral limb (i.e. toes or partial foot) is not exclusionary.
- Subjects must be over 6 months post-amputation at the time of lead placement.
- Subjects must be between the ages of 22 and 70 years old. Participants outside this age range may be at an increased medical risk and have an increased risk of fatigue during testing.
- Subjects must have used their current prosthesis for at least 6 months and achieved at least K-1 ambulator status at the time of lead placement, as determined by the Amputee Mobility Predictor.
Who cannot join
- Subjects must not have any serious disease or disorder that could affect their ability to participate in this study.
- Female subjects of childbearing age must not be pregnant or breast-feeding.
- Subjects must not be receiving medications that affect blood coagulation.
- Subjects must not have an allergy to contrast medium or renal failure that could be exacerbated by the contrast agent used in MRIs. For this study, renal insufficiency will be determined through blood work and defined as BUN of 30 or less and Creatinine of 1.5 or less.
- Subjects may not have a hemoglobin A1c level above 8.0 mg/dl at time of implant.
- Subjects may not have any implanted medical devices that are not cleared for MRI.
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- Subjects with a T-Score higher than 63 on the 18-question Brief Symptoms Inventory (BSI-18) who have undergone discussions with and been deemed unsuitable by the Principal Investigator, a study physician, and a psychologist
- Subjects may not have a cardiac pacemaker.
- Subjects may not have a cardioverter defibrillator.
- Subjects may not be currently receiving diathermy therapy.
- Subjects may not have an implanted infusion pump.
- Subjects may not be immunosuppressed or currently receiving immunosuppressive medications.
- Subjects may not have a profession (e.g. radiology technologist) or medical condition (e.g. remissory cancer involved regular follow-up x-rays) that would increase radiation exposure in the 12 months prior to starting or after ending participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the detailed description
During the study, FDA-cleared spinal cord stimulator leads will be placed in the lumbar epidural space of lower limb amputees and steered laterally towards the dorsal spinal roots under fluoroscopic guidance. This approach is essentially identical to the FDA-cleared procedure in which these devices are placed in the lumbar epidural space for treatment of intractable low back and leg pain. In that procedure, it is common clinical practice to place 2-3 leads temporarily in the epidural space through a percutaneous approach and perform a multiday trial to determine if the patient experiences any pain reduction from spinal cord stimulation. Following the trial, the percutaneous leads are surgically removed, and the patient is referred to a neurosurgeon for permanent surgical implantation.
Similarly, in this study, the device will be tunneled percutaneously through the skin and anchored in place. Using the stylet included with the spinal cord stimulator leads, the devices will be steered laterally under fluoroscopic guidance to target the dorsal spinal nerves. During lab experiments, the leads will be connected to an external stimulator. In this study, the devices will remain in the epidural space for up to 90 days and will be surgically removed. Throughout the study, the investigators will perform a series of psychophysical evaluations to characterize the sensory percepts evoked by epidural stimulation, along with functional evaluations of the effects of stimulation on the ability to control a prosthetic limb. In addition, the investigators will perform surveys to characterize changes in phantom limb sensation and pain that occur during stimulation.
- Being tested
- Spinal cord stimulator
- Keywords
- Phantom Limb Pain, Lower-Limb Amputation, electrodes, stimulation, BKA, pain, sensation
- Medical subject headings
- Phantom Limb, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulatorDevice
Spinal cord stimulator leads (2-3 leads) will be placed in the lumbar epidural space of lower limb amputees to determine if the patient experiences any pain reduction from spinal cord stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Spinal cord stimulation | Experimental | Spinal cord stimulator leads (2-3 leads) will be placed in the lumbar epidural space of lower limb amputees to determine if the patient experiences any pain reduction from spinal cord stimulation.
Participants in this study receive spinal cord stimulation will be trans-tibial amputees that are at least six month post--amputation. Subjects will have varying levels of phantom limb sensation and pain, but should have no other significant neurological disorders. Receives: Device: Spinal cord stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Serious Device-related Adverse Events up to 90 Days Following Implantation
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.
Measured: 90 days
Minimum Amplitude of Pulse Required to Evoke Sensory Percepts
Quantify the threshold stimulus required to evoke sensory percepts during epidural spinal nerve stimulation.
Measured: 90 days
Minimum Charge Required to Evoke a Neurophysiological Response
Quantify the threshold (minimum charge) stimulus required to evoke neurophysiological responses during epidural spinal nerve stimulation
Measured: 90 days
Location of Evoked Sensation - Missing Toes
Participants reporting sensation on missing toes from spinal cord stimulation.
Measured: 90 days
Location of Evoked Sensation - Plantar Surface of Missing Foot
Participants perceiving sensation on the plantar surface of missing foot
Measured: 90 days
Secondary outcomes (3)
Change in Phantom Limb Pain Using the McGill Pain Questionnaire
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 update their perception of the limb throughout experimental sessions, as well as within a month after the device has been removed.
Measured: Pre-implant (baseline), Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and post-explant (90 days)
Qualitative Self-report of Evoked Sensations
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, vibration, itch, urge to move, touch, tap Parethetic: buzz, tingle, shock, electric current, numb
Measured: 90 days
Able to Use a Prosthetic Limb With Neural Signals
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start27 May 2021
- Primary completion3 Jul 2023
- Study completion3 Jul 2023
Why it stopped: Additional participants were not enrolled after multiple years of recruitment efforts. Funding expired.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Traumatic Amputation of Lower ExtremityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee Fisher, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lee Fisher, PhD, University of Pittsburgh
- Investigators
- Lee E Fisher, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547582
- Sponsor's protocol ID
- STUDY19010019
- Other IDs
- 1UH3NS100541-01A1
- Acronym
- SCS-90
- Status last verified
- Dec 2025
- First submitted
- 7 Sep 2020
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The investigators may share data with researchers at other centers for the purpose of data analysis and collaboration.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees, 90-Day
- ClinicalTrials.gov ID
- NCT04547582
- Acronym / sponsor ID
- SCS-90 / STUDY19010019
- Keywords
- Phantom Limb Pain, Lower-Limb Amputation, electrodes, stimulation, BKA, pain, sensation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Additional participants were not enrolled after multiple years of recruitment efforts. Funding expired.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Lee Fisher, PhDUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 27 May 2021 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Posted 7 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During the study, FDA-cleared spinal cord stimulator leads will be placed in the lumbar epidural space of lower limb amputees and steered laterally towards the dorsal spinal roots under fluoroscopic guidance. This approach is essentially identical to the FDA-cleared procedure in which these devices are placed in the lumbar epidural space for treatment of intractable low back and leg pain. In that procedure, it is common clinical practice to place 2-3 leads temporarily in the epidural space through a percutaneous approach and perform a multiday trial to determine if the patient experiences any pain reduction from spinal cord stimulation. Following the trial, the percutaneous leads are surgically removed, and the patient is referred to a neurosurgeon for permanent surgical implantation.
Similarly, in this study, the device will be tunneled percutaneously through the skin and anchored in place. Using the stylet included with the spinal cord stimulator leads, the devices will be steered laterally under fluoroscopic guidance to target the dorsal spinal nerves. During lab experiments, the leads will be connected to an external stimulator. In this study, the devices will remain in the epidural space for up to 90 days and will be surgically removed. Throughout the study, the investigators will perform a series of psychophysical evaluations to characterize the sensory percepts evoked by epidural stimulation, along with functional evaluations of the effects of stimulation on the ability to control a prosthetic limb. In addition, the investigators will perform surveys to characterize changes in phantom limb sensation and pain that occur during stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal cord stimulation | Experimental | Device: Spinal cord stimulatorSpinal cord stimulator leads (2-3 leads) will be placed in the lumbar epidural space of lower limb amputees to determine if the patient experiences any pain reduction from spinal cord stimulation. Participants in this study receive spinal cord stimulation will be trans-tibial amputees that are at least six month post--amputation. Subjects will have varying levels of phantom limb sensation and pain, but should have no other significant neurological disorders. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must have an amputation of one lower limb, at a level between the ankle and knee joints. Minor amputation of the contralateral limb (i.e. toes or partial foot) is not exclusionary.
- Subjects must be over 6 months post-amputation at the time of lead placement.
- Subjects must be between the ages of 22 and 70 years old. Participants outside this age range may be at an increased medical risk and have an increased risk of fatigue during testing.
- Subjects must have used their current prosthesis for at least 6 months and achieved at least K-1 ambulator status at the time of lead placement, as determined by the Amputee Mobility Predictor.
Key exclusion criteria (13 listed)
- Subjects must not have any serious disease or disorder that could affect their ability to participate in this study.
- Female subjects of childbearing age must not be pregnant or breast-feeding.
- Subjects must not be receiving medications that affect blood coagulation.
- Subjects must not have an allergy to contrast medium or renal failure that could be exacerbated by the contrast agent used in MRIs. For this study, renal insufficiency will be determined through blood work and defined as BUN of 30 or less and Creatinine of 1.5 or less.
- Subjects may not have a hemoglobin A1c level above 8.0 mg/dl at time of implant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal cord stimulatorSpinal cord stimulator leads (2-3 leads) will be placed in the lumbar epidural space of lower limb amputees to determine if the patient experiences any pain reduction from spinal cord stimulation. | Device | Spinal cord stimulation |
Primary outcome
Number of Participants Experiencing Serious Device-related Adverse Events up to 90 Days Following Implantation
Time frame: 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.
Minimum Amplitude of Pulse Required to Evoke Sensory Percepts
Time frame: 90 days
Quantify the threshold stimulus required to evoke sensory percepts during epidural spinal nerve stimulation.
Minimum Charge Required to Evoke a Neurophysiological Response
Time frame: 90 days
Quantify the threshold (minimum charge) stimulus required to evoke neurophysiological responses during epidural spinal nerve stimulation
Location of Evoked Sensation - Missing Toes
Time frame: 90 days
Participants reporting sensation on missing toes from spinal cord stimulation.
Location of Evoked Sensation - Plantar Surface of Missing Foot
Time frame: 90 days
Participants perceiving sensation on the plantar surface of missing foot
3 secondary outcomes
Change in Phantom Limb Pain Using the McGill Pain Questionnaire
Time frame: Pre-implant (baseline), Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and post-explant (90 days)
Qualitative Self-report of Evoked Sensations
Time frame: 90 days
Able to Use a Prosthetic Limb With Neural Signals
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The investigators may share data with researchers at other centers for the purpose of data analysis and collaboration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee E Fisher, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal cord stimulator in people with Traumatic Amputation of Lower Extremity and Phantom Limb Pain, run by Lee Fisher, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Serious Device-related Adverse Events up to 90 Days Following Implantation (time frame: 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.