NCT05433064

Spinal Cord Stimulation for Spinal Cord Injury Patients - Regain Walk and Alleviate Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Buddhist Tzu Chi General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study aims to examine the plausible interventional mechanisms underlying the effects of epidural spinal cord stimulation.

Detailed description

The purpose of this study is for the treatment of spinal cord injury (SCI) paralysis patients use the signal by electrophysiological analysis of epidural spinal cord stimulation (SCS) settings that promote lower limb activity so that SCI patients can restore the ability to stand and walk under multiple sensory stimuli and multimodal electrical stimulation rehabilitation. The investigators hope to establish an atresia nerve regulation strategy and observe that the original blocked neural circuits can improve nerve plasticity by SCS. Even can establish new connections through residual nerves and allow SCI patients to rebuild neural circuits without SCS to restore lower limb mobility and improve quality of life.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	Epidural Stimulator	Subjects will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord. After 2 weeks recovery,patients will undergo a structured program of physical rehabilitation and electrical stimulation.

Timeline

• Start date: 2020-05-01
• Primary completion: 2025-07-31
• Completion: 2025-09-30
• First posted: 2022-06-27
• Last updated: 2025-09-19

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated device study