NCT07109804

Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a study about deep brain stimulation (DBS) as an investigational treatment for walking impairment following spinal cord injury (SCI). The purpose of this study is to assess the feasibility and inform on the safety, and efficacy of CnF DBS to improve gait in SCI patients with incomplete injury who cannot effectively walk overground

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	Deep Brain Stimulation (DBS)	The DBS system delivers electrical current into deep areas of the brain. In this study, the electrical current will be delivered continuously during the study duration to an area of the brain called the cuneiform nucleus (CnF). Stimulation frequencies are anticipated to be between 20 and 50 Hertz. Participants may choose to continue stimulation following study termination. This area of the brain is associated with the body's ability to start a movement.
PROCEDURE	Deep Brain Stimulation (DBS) Device Implant Procedure	Participants will undergo a one-time implantation of Cartesia DBS electrodes (bilateral) including the Vercise pulse generator in a single surgery (up to approximately 6 hours) to implant bilateral directional DBS leads in the cuneiform nucleus.
OTHER	Training Sessions	Training sessions occurs 3 times/week at the study center to condition the subjects before DBS implantation and after DBS implantation. Each session may last up to 60 minutes. Training sessions include joint mobility (passive stretching), volitional neuromuscular activation (active hip mobility), task isolation (weight shifting), task integration (stepping), and activity rehearsal (walking).

Timeline

• Start date: 2026-04-30
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-08-07
• Last updated: 2026-04-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study