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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boston Scientific Stimulator Lead | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| Week 1 Average Stimulus Charge for All Subjects | The average stimulus (nC) required to evoke sensation during week 1 of implant duration. | 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. | 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. | 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. | During days 22-28 of implant |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| Qualitative Self-report of Evoked Sensations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee E Fisher, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
Study sponsors will have access to research data and documents in order to monitor the integrity of the study.
Study information will be shared with the study sponsor through the duration of the grant.
Data will be shared with the sponsor and/or collaborators per the stipulations of the grant and/or data sharing agreements.
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Eligibility checking ruled out participants due to congenital missing limb (not amputation), taking prescription blood thinners, or unable to refrain from physical exertion during the duration of the experiment. These individuals were either excluded, or withdrew. Others declined the surgery.
Participants were met in amputee clinics, referred by prosthetics representatives, or responded to advertisements posted at amputee support groups. The study team spoke with approximately 25 interested patients. Of these, four completed the consent process.
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| ID | Title | Description |
|---|---|---|
| FG000 | Boston Scientific Cord Stimulator Lead | 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. Boston Scientific Stimulator Lead: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The first participant experienced lead migration and early explant. This participant was later re-enrolled and completed study activities. Therefore, there are 4 unique individuals counted among the 5 consented participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Boston Scientific Cord Stimulator Lead | 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. Boston Scientific Stimulator Lead: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants implanted with stimulator leads | Posted | Mean | Full Range | milliamps | 30 days |
|
30 days (duration of implant)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Boston Scientific Cord Stimulator Lead | 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. Boston Scientific Stimulator Lead: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lead migration | Surgical and medical procedures | Systematic Assessment | Movement of spinal cord lead(s) after implant. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lee Fisher, PhD | University of Pittsburgh | 412-383-1077 | lef44@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2025 | Aug 21, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010591 | Phantom Limb |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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. |
| 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. | 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. | 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. | 30 days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants with phantom limb pain | Participants who report having phantom limb pain | Count of Participants | Participants |
|
|
|
| Primary | Week 1 Average Stimulus Charge for All Subjects | The average stimulus (nC) required to evoke sensation during week 1 of implant duration. | Posted | Mean | Full Range | nC | first 7 days of implant |
|
|
|
| Primary | Week 2 Average Stimulus Charge for All Subjects | The average stimulus (nC) required to evoke sensation during week 2 of implant duration. | Posted | Mean | Full Range | nC | During days 7-14 of implant |
|
|
|
| Primary | Week 3 Average Stimulus Charge for All Subjects | The average stimulus (nC) required to evoke sensation during week 3 of implant duration. | Participant 2 had the stimulator removed before week 3. Participants 1, 3, and 4 were included in this analysis. | Posted | Mean | Full Range | nC | During days 15 to 21 of implant |
|
|
|
| Primary | Week 4 Average Stimulus Charge for All Subjects | The average stimulus (nC) required to evoke sensation during week 4 of implant duration. | Participant 2 had the stimulator removed before week 3. Participants 1, 3, and 4 were included in this analysis. | Posted | Mean | Full Range | nC | During days 22-28 of implant |
|
|
|
| Secondary | 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. | Participants with implanted spinal cord stimulator who were able to discern specific regions of the spinal cord that evoked sensations | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | 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. | Participants implanted with spinal cord stimulator who reported sensations felt | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | 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. | 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). Three participants reported having phantom limb pain prior to the study. | Posted | Mean | Full Range | score on a scale | 30 days |
|
|
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| Secondary | 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. | Person with upper limb amputation for over two years. This subject had a high trans-humeral amputation and did not have sufficient musculature in the residual limb to achieve reliable myoelectric control of the prosthesis. Instead, she wore a Data Glove (Fifth Dimension Technologies, 5 DT) on her contralateral, intact hand, and the grasp aperature from the Data Glove was used to proportionally control the aperture of the real and cirtual DEKA hand. | Posted | Number | percentage of success identifying size | 30 days |
|
|
|
| Secondary | 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. | Person with upper limb amputation for over two years. This subject had difficulty achieving reliable prosthesis control, even with simple control schemes such as parallel dual-site control. As such, a highly simplified control scheme was implemented, in which the subject was instructed to attempt a hand grasp, and when this signal crossed a manually defined threshold, the DEKA hand was commanded to close at a constant velocity of 15 degrees/second. | Posted | Number | percentage of success identifying compli | 30 days |
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| 0 |
| 4 |
| 0 |
| 4 |
| 2 |
| 4 |
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| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Felt stim in shoulder |
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| Felt stim in fingers |
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| C6 evoked stim |
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| C7 evoked stim |
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| C8 evoked stim |
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| T1 evoked stim |
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| T2 evoked stim |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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