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

NCT07109804 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-04-23

No results posted yet for this study

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

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).

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.

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.

Sponsors & Collaborators

  • The Miami Project to Cure Paralysis

    collaborator OTHER

  • Florida

    collaborator OTHER

  • University of Miami

    lead OTHER

Principal Investigators

  • Brian R Noga, PhD · University of Miami

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07109804 on ClinicalTrials.gov