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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07109804
Status
Recruiting
Apply to this trial

Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
22 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Deep Brain Stimulation (DBS) — DEVICE
    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 — 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 — OTHER
    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).

Study Details

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 Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Deep Brain Stimulation (DBS)
    Participants will be in the DBS study group for up to 34 weeks.

Primary Outcome Measure

Change in walking speed measured by 10-meter walk test [ Time Frame: baseline, up to 34 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The Miami Project to Cure ParalysisMiamiFlorida33136
Letitia Fisher, BLA
[email protected]
3052433056
David McMillan, PhD
[email protected]
305-243-5569
Brian Noga, PhD (PRINCIPAL_INVESTIGATOR)
University of Miami School Of MedicineMiamiFlorida33136
Brian R Noga, PhD
[email protected]
305-243-6155
Letitia FISHER, BLA
[email protected]
305-243-3056
Brian R Noga, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
The Miami Project to Cure Paralysis· Miami, FLUniversity of Miami School Of Medicine· Miami, FL

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