NCT03027947: SCS-LL

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

Completed NA Last updated 12 April 2022

What this trial tests

NA trial testing Spinal cord stimulator in Traumatic Amputation of Lower Extremity in 5 participants. Completed in 8 September 2021.

Timeline

16 March 2017

Primary endpoint
4 March 2021

8 September 2021

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	16 March 2017
Primary completion	4 March 2021
Estimated completion	8 September 2021
Sites	1 location across United States

Drugs / interventions tested

• Spinal cord stimulator

Conditions studied

• Traumatic Amputation of Lower Extremity — all drugs for Traumatic Amputation of Lower Extremity →
• Phantom Limb Pain — all drugs for Phantom Limb Pain →

Sponsor

University of Pittsburgh

Who can join

Adults 18 to 70, any sex, with Traumatic Amputation of Lower Extremity or Phantom Limb Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Restoration of sensory feedback from the foot and reduction of phantom limb pain via closed-loop spinal cord stimulation.
   Nanivadekar AC, Bose R, Petersen BA, Okorokova EV, et al · · 2024 · cited 43× · PMID 38097809 · DOI 10.1038/s41551-023-01153-8
2. Characterizing spinal reflexes evoked by sensory spinal cord stimulation in people with lower-limb amputation.
   Bose R, Dalrymple AN, Sarma D, Petersen BA, et al · · 2025 · cited 1× · PMID 41034988 · DOI 10.1186/s12984-025-01720-x