NCT06596174

Effect of tSCS on Ankle Movement Training in Individuals With SCI

Effect of tSCS on Ankle Movement Training - Evidence From Spinal Circuitry Adaptation in Individuals With SCI

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Chang Gung University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

This clinical trial explores the effectiveness of transcutaneous spinal cord stimulation (tSCS), a non-invasive technique, in facilitating spinal circuitry adaptation in individuals with spinal cord injury (SCI). While epidural spinal cord stimulation (eSCS) has shown functional benefits, its application is limited by the side effects associated with implanted electrodes. tSCS, which shares a similar mechanism but does not require surgery, has yet to be extensively studied in large human trials. The study aims to: Determine optimal tSCS parameters for non-invasive spinal stimulation. Investigate the priming effect of tSCS on spinal circuitry during machine-assisted ankle movement training. Examine the long-term clinical outcomes of combining tSCS with ankle movement training in individuals with incomplete SCI. The trial will include both healthy participants and individuals with complete and incomplete SCI, using the soleus post-activation depression (PAD) model to evaluate spinal circuitry adaptation. The results will provide insights into spinal re-adaptation and potentially introduce a novel, non-invasive approach for SCI rehabilitation.

Conditions

• SCI - Spinal Cord Injury

Interventions

Type	Name	Description
PROCEDURE	Transcutaneous spinal cord stimulation (tSCS)	The subjects will undergo 20 minutes transcutaneous spinal cord stimulation (tSCS).
PROCEDURE	Short-term Machine-Assisted Ankle Movement Training with tSCS	The subjects will undergo 30 minutes of machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS) at a time
PROCEDURE	Long-term Effects of Machine-Assisted Ankle Movement Training with tSCS	The subjects will undergo machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS). Each session will last for 30 minutes, conducted three times per week, over a period of four weeks.

Timeline

• Start date: 2024-11-25
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2024-09-19
• Last updated: 2024-11-26

Locations

1 site across 1 country: Taiwan