NCT06596369

Transcutaneous Spinal Cord Stimulation for Upper Extremity Function

Transcutaneous Spinal Cord Stimulation to Facilitate Recovery of Upper Extremity Function in Individuals With Stroke or Spinal Cord Injury - A Pilot Study

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Transcutaneous electrical stimulation (tcES) of the spinal cord has shown great promise in restoring upper extremity function after spinal cord injury (SCI). More recently, the use of invasive, epidural electrical stimulation of the spinal cord has also demonstrated promise in restoring upper extremity function post-stroke. However, the effect of stimulation parameters such as electrode configuration and stimulation frequency on excitability of the nervous system remains unknown preventing the opportunity to fully exploit this noninvasive stimulation paradigm. Additionally, the utility of noninvasive tcES in the stroke population remains unexplored. This project utilizes a comprehensive set of neurophysiological techniques, in combination with carefully chosen motor tasks, to directly link and assess the effects of stimulation parameters on neural excitability and upper extremity function during and following the delivery of cervical tcES in individuals with SCI and stroke. The fundamental knowledge gained from this project will ultimately improve the implementation of this novel and non-invasive neuromodulatory tool through an improved understanding of how tcES can facilitate recovery of function.

Detailed description

In the first two aims of this study we explore the effects of stimulation configurations on neural excitability. Specifically we will explore the effects of electrode placement and stimulation frequency on measures of corticospinal and intracortical excitability. In the last aim of this study, individuals will participate in an interventional trial combining activity-based therapy with tcES. We will explore whether this intervention facilitated improvements in upper extremity function through clinical and neurophysiological assessments.

Conditions

• Spinal Cord Injuries
• Stroke

Interventions

Type	Name	Description
DEVICE	Transcutaneous spinal cord stimulation	Continuous, sub motor threshold stimulation is delivered through surface electrodes placed over the cervical spine region.
OTHER	Upper extremity rehabilitation	Using the ReJoyce system individuals will engage in upper extremity rehabilitation.

Timeline

• Start date: 2024-06-15
• Primary completion: 2029-09-14
• Completion: 2029-12-30
• First posted: 2024-09-19
• Last updated: 2026-04-13

Locations

2 sites across 1 country: Canada