Epidural Spinal Cord Stimulation for Sensory Restoration and Phantom Limb Pain in Upper-Limb Amputees
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/12/2018 |
| Start Date: | November 2015 |
| End Date: | December 2022 |
| Contact: | Bree Bigelow |
| Email: | bree.bigelow@pitt.edu |
| Phone: | 412-648-4035 |
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.
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.
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.
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.
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
We found this trial at
1
site
4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Phone: 412-648-4035
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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