NCT04736849

Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

Pilot Study of Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Peter J. Grahn, Ph.D. · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

A study to compare electrophysiologic activity of epidural stimulation and dorsal root ganglion stimulation, as well as quantify changes in motor performance with both types of stimulation over the course of 10 rehabilitation sessions.

Detailed description

This study aims to expand the understanding of how electrical spinal stimulation enables function, specifically the pathophysiological mechanisms of action underlying spinal electrical stimulation after SCI, and to address the gap in knowledge of spinal sensorimotor network inputs and outputs generated by spinal electrical stimulation in humans with SCI.

Conditions

• Spinal Cord Injuries
• Paraplegia
• Tetraplegia
• Paralysis

Interventions

Type	Name	Description
DEVICE	Percutaneous epidural and dorsal root stimulation	Abbott percutaneous trial lead for dorsal root ganglion neurostimulation (Model MN10350) Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Abbott clinician programmer for epidural and dorsal root ganglion neurostimulation (Model 3874) Ripple Neuromed Nomad Neurostimulation System

Timeline

• Start date: 2021-09-24
• Primary completion: 2025-03-19
• Completion: 2025-03-19
• First posted: 2021-02-03
• Last updated: 2025-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study