Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees, 90-Day

Phantom Limb Pain Clinical Trial

— SCS-90  

Official title:

Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees, 90-Day

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04547582
• Other study ID #: STUDY19010019
• Secondary ID: 1UH3NS100541-01A
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2016
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: University of Pittsburgh
• Contact: Sydney Bader
• Phone: 412-648-4196
• Email: SYB17[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Subjects must be over 6 months post-amputation at the time of lead placement.

3. 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.

4. 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.

Exclusion Criteria:

1. Subjects must not have any serious disease or disorder that could affect their ability to participate in this study.

2. Female subjects of childbearing age must not be pregnant or breast-feeding.

3. Subjects must not be receiving medications that affect blood coagulation.

4. 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.

5. Subjects may not have a hemoglobin A1c level above 8.0 mg/dl at time of implant.

6. Subjects may not have any implanted medical devices that are not cleared for MRI.

7. 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

8. Subjects may not have a cardiac pacemaker.

9. Subjects may not have a cardioverter defibrillator.

10. Subjects may not be currently receiving diathermy therapy.

11. Subjects may not have an implanted infusion pump.

12. Subjects may not be immunosuppressed or currently receiving immunosuppressive medications.

13. 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.

Related Conditions & MeSH terms

• Amputation, Traumatic
• Phantom Limb
• Phantom Limb Pain
• Traumatic Amputation of Lower Extremity

Intervention

Device:
• Spinal cord stimulator
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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Lee Fisher, PhD	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 days
Primary	Location of evoked sensory percepts	Document where on the body the subject perceives the stimulation locations.	90 days
Primary	Stimulation perceptual thresholds to a variety of stimulus parameters	Quantify the threshold (minimum charge and pulse rate) stimulus required to evoke sensory percepts during epidural spinal nerve stimulation.	90 days
Primary	Stimulation neurophysiology thresholds to a variety of stimulus parameters	Quantify the threshold (minimum charge and pulse rate) stimulus required to evoke neurophysiological responses during epidural spinal nerve stimulation	90 days
Secondary	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 would therefore represent 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.	90 days
Secondary	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.	90 days
Secondary	Ability 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.	90 days