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Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury
Sponsor: University of Miami
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
Key Details
Gender
All
Age Range
22 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2026-04-30
Completion Date
2026-12-31
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
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.
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.
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).
Locations (2)
The Miami Project to Cure Paralysis
Miami, Florida, United States
University of Miami School Of Medicine
Miami, Florida, United States