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More info
You can access this
clinical trial
if you have
Traumatic Amputation of Lower Extremity or Phantom Limb Pain
and you are
between 18 and 70
years old
-
The phase for this study is not defined.
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The purpose

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.

Provided treatments

  • Device: Spinal cord stimulator
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Tris trial is registered with FDA with number: NCT03027947. The sponsor of the trial is University of Pittsburgh and it is looking for 10 volunteers for the current phase.
Official trial title:
Spinal Root and Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees