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

NANot yet recruitingINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Spinal Cord Injuries
Interventions
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).

Trial Locations (1)

33136

University of Miami School Of Medicine, Miami

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

The Miami Project to Cure Paralysis

OTHER

collaborator

Florida

OTHER

lead

University of Miami

OTHER

NCT07109804 - Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury | Biotech Hunter | Biotech Hunter