6
Participants
Start Date
November 30, 2025
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2026
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).
University of Miami School Of Medicine, Miami
Collaborators (1)
The Miami Project to Cure Paralysis
OTHER
Florida
OTHER
University of Miami
OTHER