NCT04627441

Transcutaneous and Epidural Stimulation in SCI

A Pilot Study of the Characterization of Transcutaneous and Epidural Spinal Stimulation for Enabling Motor Function in Humans With Motor Complete Paraplegia

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Kristin Zhao, PhD · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The study seeks to improve the scientific understanding of how two electrical stimulation techniques, one which delivers electricity to the skin surface over the spine (transcutaneous electrical spinal stimulation \[TESS\]) and another which is implanted onto the dura mater of the spinal cord (epidural electrical stimulation \[EES\]), facilitate spinal circuitry to enable function after SCI.

Detailed description

The study will compare motor activity and clinical outcomes over the course of TESS and EES in combination with physical rehabilitation. The primary outcome data collected will be used to characterize and compare spinal sensorimotor activity in muscles below the level of injury during TESS and EES-enabled motor tasks in persons with chronic motor complete paralysis of the lower extremities due to traumatic SCI. Furthermore, data collected will be used as a proof of concept that TESS can be used to determine recovery of function during EES-enabled motor tasks. Following exposure to each stimulation intervention, data collection will include changes to spasticity, body composition, metabolic variables, and spinal imaging to assess the effect of either TESS or EES stimulation.

Conditions

• Paraplegia, Spinal
• Paraplegia, Complete
• Paraplegia; Traumatic

Interventions

Type	Name	Description
DEVICE	Transcutaneous spinal cord stimulator	DS8R Electrical Stimulator For Human Research
DEVICE	Epidural spinal cord stimulator system	Spectra WaveWriter Epidural Spinal Cord Stimulator System with CoverEdge 32 Electrode Surgical Lead

Timeline

• Start date: 2022-12-16
• Primary completion: 2025-12-16
• Completion: 2025-12-16
• First posted: 2020-11-13
• Last updated: 2022-10-04

Regulatory

• FDA-regulated device study