NCT05095454

Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With SCI

A Pilot Study to Compare Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With Spinal Cord Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Kristin Zhao, PhD · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

A study comparing short-term delivery of epidural spinal stimulation versus transcutaneous spinal stimulation.

Detailed description

The purpose of this study is to compare spinal motor nerve response to electrical stimulation delivered directly to the epidural space, and delivered through the skin (transcutaneously), and to measure any changes in motor performance over the course of about 5 months, during and after using one of the two types of stimulation.

Conditions

• Paraplegia
• Tetraplegia
• Paralysis
• Quadraplegia

Interventions

Type	Name	Description
DEVICE	Percutaneous epidural electrical spinal stimulation	Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System
DEVICE	Transcutaneous electrical spinal stimulation	Digitimer DS8R Bipolar Constant Current Stimulator

Timeline

• Start date: 2022-03-04
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2021-10-27
• Last updated: 2024-07-09
• Results posted: 2024-07-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study