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

Completed · Not applicable

Conditions studied: Traumatic Amputation of Lower Extremity, Phantom Limb Pain

In brief

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.

Key facts

Study ID

NCT03027947

Run by

University of Pittsburgh

People needed

5

Starts

2017-03-16

Expected to finish

2021-09-08

Last updated by the study team

2022-04-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Debbie — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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