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

NCT03027947 | Completed DMC

• 2 other identifiers: STUDY19030223UH3NS100541
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Amputation of Lower Extremity; Phantom Limb Pain

Keywords

Phantom Limb Pain; Lower-Limb Amputation; Electrodes; Stimulation; Pain; Sensation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Location of evoked sensory percepts

  30 days

• Qualitative self-report of evoked sensations

  30 days

• Change (reduction) in pain ratings

  30 days

• Ability to use a prosthetic limb with neural signals

  30 days

Study Arms (1)

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 and trans-femoral 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.

Device: Spinal cord stimulator

Interventions

Spinal cord stimulator DEVICE

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.

Spinal cord stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Debbie

Pittsburgh, Pennsylvania, 15101, United States

Location

Related Publications (5)

• 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.

  PMID: 18295618 BACKGROUND

• 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.

  PMID: 24852068 BACKGROUND

• 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. doi: 10.1682/jrrd.2007.09.0151.

  PMID: 19165686 BACKGROUND

• 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.

  PMID: 23240657 BACKGROUND

• 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.

  PMID: 23668228 BACKGROUND

MeSH Terms

Conditions

Phantom Limb; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Lee Fisher, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine, Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: January 23, 2017
• Study Start: March 16, 2017
• Primary Completion: March 4, 2021
• Study Completion: September 8, 2021
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Information may be shared while data is being recorded, analyzed, and/or prior to publication. Data may be available after manuscripts are published.
• Access Criteria: Data may be shared through a restricted access portal created by the National Institutes of Health or directly with scientists at other centers under a data use agreement.

Locations

US (1)