Spinal Root and Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 2/9/2019 |
| Start Date: | March 16, 2017 |
| End Date: | July 2022 |
| Contact: | Bree Bigelow |
| Email: | bree.bigelow@pitt.edu |
| Phone: | 412-648-4035 |
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.
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.
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.
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.
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
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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