Phantom LimbPhantomLimbNCT02684201
Epidural Spinal Cord Stimulation for Sensory Restoration and Phantom Limb Pain in Upper-Limb Amputees
A study testing Boston Scientific Stimulator Lead in people with Phantom Limb, run by Lee Fisher, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Phantom Limb
- What is being tested?
- Boston Scientific Stimulator Lead
- 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
- 1 Nov 2015to 1 Aug 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the detailed description
The purpose of this research study is to characterize the types of sensations that can be produced by stimulating the spinal nerves in upper-limb amputees, as well as the effects of that stimulation on phantom limb pain. The study involves a medical procedure to temporarily place one to three stimulation electrodes in the space near the spinal cord. This medical procedure will be performed under local anesthesia, and will take approximately one to two hours. Afterwards, the electrodes will be connected to an external stimulator and a series of experiments will be performed to characterize the types of sensations generated by electrical stimulation of the spinal cord and spinal nerves, as well as to measure the effect of stimulation on phantom limb sensations and phantom limb pain. Over the course of less than 30 days, there will be up to 20 of these experimental sessions. At the end of the final experimental session, the stimulation electrodes will be removed by gently pulling on them.
The investigators are inviting participants to consider participating in this research because they have an upper-limb amputation. Participants must be between the ages of 18 and 70 and at least one year post-amputation. Participants must be willing to travel to the University of Pittsburgh at least twice per week for 30 days.
Participants cannot have any serious diseases or disorders that affect your ability to participate in this study. Women who are pregnant or plan to become pregnant during the study cannot be included. The investigators will ask females of child-bearing potential to undergo a urine pregnancy test prior to any procedures (such as MRI, x-ray, fluoroscopy) that may disrupt the healthy development of an unborn child. If participants are currently taking any medications that thin their blood, participants will not be eligible for this study. Participants will have to meet other criteria to be eligible, which will be reviewed with participants upon their consent. The investigators will screen up to 15 people and expect that up to 10 individuals will complete this study.
- Conditions
- Phantom Limb
- Being tested
- Boston Scientific Stimulator Lead
- Keywords
- Phantom Limb, Upper Amputee, Electrodes, Implant, Pain
- 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.
Boston Scientific Stimulator LeadDevice
A Boston Scientific (PMA P030017) spinal cord stimulator lead will be placed in the cervical epidural space of ten upper-limb amputees and steered laterally towards the dorsal spinal roots under fluoroscopic guidance.
| Study group | Role | What they receive |
|---|---|---|
| Boston Scientific cord stimulator lead | Experimental | A Boston Scientific Stimulator Lead (PMA P030017) will be placed in the cervical epidural space of ten upper-limb amputees and steered laterally towards the dorsal spinal roots under fluoroscopic guidance. Receives: Device: Boston Scientific Stimulator Lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulation Thresholds to a Variety of Stimulus Parameters
Quantify the threshold (minimum charge) stimulus required to evoke sensation and neurophysiological responses during epidural spinal nerve stimulation, and monitor changes in those percepts and responses over time.
Measured: 30 days
Week 1 Average Stimulus Charge for All Subjects
The average stimulus (nC) required to evoke sensation during week 1 of implant duration.
Measured: first 7 days of implant
Week 2 Average Stimulus Charge for All Subjects
The average stimulus (nC) required to evoke sensation during week 2 of implant duration.
Measured: During days 7-14 of implant
Week 3 Average Stimulus Charge for All Subjects
The average stimulus (nC) required to evoke sensation during week 3 of implant duration.
Measured: During days 15 to 21 of implant
Week 4 Average Stimulus Charge for All Subjects
The average stimulus (nC) required to evoke sensation during week 4 of implant duration.
Measured: During days 22-28 of implant
Secondary outcomes (5)
Number of Participants Who Were Able to Discern Specific Regions of the Spinal Cord That Evoked Sensations
Evaluate the relationship between stimulation parameters and the modality and naturalness of perceived sensations.
Measured: 30 days
Qualitative Self-report of Evoked Sensations
Document the subjective perception of cervical 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.
Measured: 30 days
Change in Pain Ratings After Study Completion
Participants were asked to complete the McGill pain questionnaire at baseline, and weekly throughout implant. We expected to see a decrease in the pain level due to electrical stimulation. A positive score indicates a decrease in level of pain (baseline - study end). Minimum score is 0. Maximum score is 80. The higher the number, the greater the pain. This outcome measure suntracts the baseline pain score from the final pain score. A positive score indicates a reduction in pain from baseline.
Measured: 30 days
Success Rate During Control of Prosthetic Hand to Identify Object Size
Investigators will test the subject's ability to use a myoelectric prosthetic hand 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 such as pressure at the finger tips or joint angles. In both the presence and absence of stimulation, subjects will be asked to perform tasks such as manipulating blocks, opening a jar, or identifying the stiffness and size of various objects.
Measured: 30 days
Success Rate During Control of Prosthetic Hand to Identify Object Compliance (Soft, Medium, Hard)
Investigators tested the subject's ability to use a myoelectric prosthetic hand 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 was modulated based on signals recorded from the limb such as pressure at the finger tips or joint angles. In both the presence and absence of stimulation, subjects were asked to perform tasks such as manipulating blocks, opening a jar, or identifying the stiffness (soft, medium, hard) and size of various objects.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study start1 Nov 2015
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
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 Phantom LimbStudies 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
- NCT02684201
- Sponsor's protocol ID
- STUDY19100220
- Acronym
- PhantomLimb
- Status last verified
- Sep 2025
- First submitted
- 11 Nov 2015
- Last updated
- 8 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Study sponsors will have access to research data and documents in order to monitor the integrity of the study.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Spinal Cord Stimulation for Sensory Restoration and Phantom Limb Pain in Upper-Limb Amputees
- ClinicalTrials.gov ID
- NCT02684201
- Acronym / sponsor ID
- PhantomLimb / STUDY19100220
- Conditions
- Phantom Limb
- Keywords
- Phantom Limb, Upper Amputee, Electrodes, Implant, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Lee Fisher, PhDUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Posted 8 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this research study is to characterize the types of sensations that can be produced by stimulating the spinal nerves in upper-limb amputees, as well as the effects of that stimulation on phantom limb pain. The study involves a medical procedure to temporarily place one to three stimulation electrodes in the space near the spinal cord. This medical procedure will be performed under local anesthesia, and will take approximately one to two hours. Afterwards, the electrodes will be connected to an external stimulator and a series of experiments will be performed to characterize the types of sensations generated by electrical stimulation of the spinal cord and spinal nerves, as well as to measure the effect of stimulation on phantom limb sensations and phantom limb pain. Over the course of less than 30 days, there will be up to 20 of these experimental sessions. At the end of the final experimental session, the stimulation electrodes will be removed by gently pulling on them.
The investigators are inviting participants to consider participating in this research because they have an upper-limb amputation. Participants must be between the ages of 18 and 70 and at least one year post-amputation. Participants must be willing to travel to the University of Pittsburgh at least twice per week for 30 days.
Participants cannot have any serious diseases or disorders that affect your ability to participate in this study. Women who are pregnant or plan to become pregnant during the study cannot be included. The investigators will ask females of child-bearing potential to undergo a urine pregnancy test prior to any procedures (such as MRI, x-ray, fluoroscopy) that may disrupt the healthy development of an unborn child. If participants are currently taking any medications that thin their blood, participants will not be eligible for this study. Participants will have to meet other criteria to be eligible, which will be reviewed with participants upon their consent. The investigators will screen up to 15 people and expect that up to 10 individuals will complete this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Boston Scientific cord stimulator lead | Experimental | Device: Boston Scientific Stimulator LeadA Boston Scientific Stimulator Lead (PMA P030017) will be placed in the cervical epidural space of ten upper-limb amputees and steered laterally towards the dorsal spinal roots under fluoroscopic guidance. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Boston Scientific Stimulator LeadA Boston Scientific (PMA P030017) spinal cord stimulator lead will be placed in the cervical epidural space of ten upper-limb amputees and steered laterally towards the dorsal spinal roots under fluoroscopic guidance. | Device | Boston Scientific cord stimulator lead |
Primary outcome
Stimulation Thresholds to a Variety of Stimulus Parameters
Time frame: 30 days
Quantify the threshold (minimum charge) stimulus required to evoke sensation and neurophysiological responses during epidural spinal nerve stimulation, and monitor changes in those percepts and responses over time.
Week 1 Average Stimulus Charge for All Subjects
Time frame: first 7 days of implant
The average stimulus (nC) required to evoke sensation during week 1 of implant duration.
Week 2 Average Stimulus Charge for All Subjects
Time frame: During days 7-14 of implant
The average stimulus (nC) required to evoke sensation during week 2 of implant duration.
Week 3 Average Stimulus Charge for All Subjects
Time frame: During days 15 to 21 of implant
The average stimulus (nC) required to evoke sensation during week 3 of implant duration.
Week 4 Average Stimulus Charge for All Subjects
Time frame: During days 22-28 of implant
The average stimulus (nC) required to evoke sensation during week 4 of implant duration.
5 secondary outcomes
Number of Participants Who Were Able to Discern Specific Regions of the Spinal Cord That Evoked Sensations
Time frame: 30 days
Qualitative Self-report of Evoked Sensations
Time frame: 30 days
Change in Pain Ratings After Study Completion
Time frame: 30 days
Success Rate During Control of Prosthetic Hand to Identify Object Size
Time frame: 30 days
Success Rate During Control of Prosthetic Hand to Identify Object Compliance (Soft, Medium, Hard)
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Study sponsors will have access to research data and documents in order to monitor the integrity of the study.
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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 Boston Scientific Stimulator Lead in people with Phantom Limb, 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 3 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: finished, as of the sponsor's last update on 8 Oct 2025. 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 8 Oct 2025). 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?
Stimulation Thresholds to a Variety of Stimulus Parameters (time frame: 30 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 8 Oct 2025.