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

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ClinicalTrials.gov Identifier: NCT03027947
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Lee Fisher, PhD, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Traumatic Amputation of Lower Extremity Phantom Limb Pain Device: Spinal cord stimulator Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spinal Root and Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees
Actual Study Start Date : March 16, 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

Arm Intervention/treatment
Experimental: Spinal cord stimulation

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
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.




Primary Outcome Measures :
  1. Stimulation perceptual thresholds to a variety of stimulus parameters [ Time Frame: 30 days ]
    Quantify the threshold (minimum charge and pulse rate) stimulus required to evoke sensory percepts during epidural spinal nerve stimulation.

  2. Stimulation neurophysiology thresholds to a variety of stimulus parameters [ Time Frame: 30 days ]
    Quantify the threshold (minimum charge and pulse rate) stimulus required to evoke neurophysiological responses during epidural spinal nerve stimulation


Secondary Outcome Measures :
  1. Location of evoked sensory percepts [ Time Frame: 30 days ]
    Document where on the body the subject perceives the stimulation locations.

  2. Qualitative self-report of evoked sensations [ Time Frame: 30 days ]
    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.

  3. Change (reduction) in pain ratings [ Time Frame: 30 days ]
    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.

  4. Ability to use a prosthetic limb with neural signals [ Time Frame: 30 days ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027947


Contacts
Contact: Bree Bigelow 412-648-4035 bree.bigelow@pitt.edu
Contact: Debbie Harrington 412-383-1355 debbie.harrington@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Bree Bigelow    412-648-4035    bree.bigelow@pitt.edu   
Contact: Debbie Harrington    412-383-1355    debbie.harrington@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Lee Fisher, PhD University of Pittsburgh

Publications:
Responsible Party: Lee Fisher, PhD, Assistant Professor, School of Medicine, Physical Medicine and Rehabilitation, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03027947     History of Changes
Other Study ID Numbers: PRO16060190
UH3NS100541 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators may share data with researchers at other centers for the purpose of data analysis and collaboration.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lee Fisher, PhD, University of Pittsburgh:
Phantom Limb Pain
Lower-Limb Amputation
Electrodes
Stimulation
Pain
Sensation

Additional relevant MeSH terms:
Phantom Limb
Amputation, Traumatic
Leg Injuries
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Pain
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Wounds and Injuries