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RECRUITING
NCT07109804
NA

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

Sponsor: University of Miami

View on ClinicalTrials.gov

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

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).

Locations (2)

The Miami Project to Cure Paralysis

Miami, Florida, United States

University of Miami School Of Medicine

Miami, Florida, United States