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Epidural Spinal Cord Stimulation for Sensory Restoration and Phantom Limb Pain in Upper-Limb Amputees (PhantomLimb)

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ClinicalTrials.gov Identifier: NCT02684201
Recruitment Status : Recruiting
First Posted : February 17, 2016
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Boninger, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Phantom Limb Device: Boston Scientific Stimulator Lead Not Applicable

Detailed Description:

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 15 people and expect that up to 10 individuals will complete this study.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Epidural Spinal Cord Stimulation for Sensory Restoration and Phantom Limb Pain in Upper-Limb Amputees
Study Start Date : November 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

Arm Intervention/treatment
Experimental: 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.
Device: 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.




Primary Outcome Measures :
  1. Stimulation 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 and neurophysiological responses (e.g. reflexive EMG responses, somatosensory evoked potentials) during epidural spinal nerve stimulation, and monitor changes in those percepts and responses over time.


Secondary Outcome Measures :
  1. Location and modality of evoked sensory percepts [ Time Frame: 30 days ]
    Evaluate the relationship between stimulation parameters (e.g. pulse width, pulse amplitude, stimulus location, etc) and the modality and naturalness of perceived sensations.

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

  3. Change in pain ratings after study completion [ Time Frame: 30 days ]
    Document changes in phantom limb sensation and phantom limb pain during and shortly after cervical 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. If subjects report a history of phantom limb pain, 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. Success rate during control of prosthetic hand [ Time Frame: 30 days ]
    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.



Information from the National Library of Medicine

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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 upper-limb amputation
  • must be between the ages of 18 and 70
  • be at least one year post-amputation
  • be willing to travel to the University of Pittsburgh at least twice per week for 30 days

Exclusion Criteria:

  • women who are pregnant or plan to become pregnant during the study
  • all participants cannot have any serious diseases or disorders that affect your ability to participate in this study
  • must not be currently taking any medications that thin your blood

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): NCT02684201


Contacts
Contact: Bree Bigelow 412-648-4035 bree.bigelow@pitt.edu
Contact: Debbie E 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
Investigators
Principal Investigator: Michael L Boninger, MD University of Pittsburgh

Responsible Party: Michael Boninger, Medical Doctor; Professor and Chair of Physical Medicine and Rehabilitation, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02684201     History of Changes
Other Study ID Numbers: PRO15010131
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study sponsors will have access to research data and documents in order to monitor the integrity of the study. Representatives from the Department of the Army Human Research Protection Office may also provide study oversight and monitoring as part of their responsibility to protect human research subject volunteers.

Keywords provided by Michael Boninger, University of Pittsburgh:
Phantom Limb
Upper Amputee
Electrodes
Implant
Pain

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