Spinal Root and Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees

Phantom Limb Pain Clinical Trial

— SCS-LL  

Official title:

Spinal Root and Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027947
• Other study ID #: STUDY19030223
• Secondary ID: UH3NS100541
• Status: Completed
• Phase: N/A
• Start date: March 16, 2017
• Est. completion date: September 8, 2021

Study information

• Verified date: April 2022
• Source: University of Pittsburgh
• Contact: n/a
• 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 typically removed by gently pulling on them, 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 secured in place with tape or suture. 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 less than 30 days and will be removed by gently pulling on the external portion. 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: Completed
• Enrollment: 5
• Est. completion date: September 8, 2021
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• have an amputation of at least one lower limb, at a level between the ankle and hip joints
• be at least 6 months post-amputation at time of lead placement

Exclusion Criteria:

• women who are pregnant or breast-feeding
• has any serious diseases or disorders that affect ability to participate
• currently receiving medications that may affect blood coagulation
• allergic to contrast medium, or has kidney failure that could be exacerbated by contrast agent
• implanted metallic devices that are not cleared for MRI

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	Debbie	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Deer TR, Grigsby E, Weiner RL, Wilcosky B, Kramer JM. A prospective study of dorsal root ganglion stimulation for the relief of chronic pain. Neuromodulation. 2013 Jan-Feb;16(1):67-71; discussion 71-2. doi: 10.1111/ner.12013. Epub 2012 Dec 14. — View Citation

Etter K, Borgia M, Resnik L. Prescription and repair rates of prosthetic limbs in the VA healthcare system: implications for national prosthetic parity. Disabil Rehabil Assist Technol. 2015 Nov;10(6):493-500. doi: 10.3109/17483107.2014.921246. Epub 2014 May 22. — View Citation

Liem L, Russo M, Huygen FJ, Van Buyten JP, Smet I, Verrills P, Cousins M, Brooker C, Levy R, Deer T, Kramer J. A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. Neuromodulation. 2013 Sep-Oct;16(5):471-82; discussion 482. doi: 10.1111/ner.12072. Epub 2013 May 13. — View Citation

Raichle KA, Hanley MA, Molton I, Kadel NJ, Campbell K, Phelps E, Ehde D, Smith DG. Prosthesis use in persons with lower- and upper-limb amputation. J Rehabil Res Dev. 2008;45(7):961-72. — View Citation

Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	30 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	30 days
Secondary	Location of evoked sensory percepts	Document where on the body the subject perceives the stimulation locations.	30 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.	30 days
Secondary	Change (reduction) in pain ratings	Document changes in phantom limb pain during and shortly after lumbosacral epidural spinal nerve stimulation in amputees. 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 each experimental session, as well as within a month after the device has been removed.	30 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.	30 days