Actively Recruiting
Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury
Led by University of Miami · Updated on 2026-04-23
6
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
T
The Miami Project to Cure Paralysis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects between ages of 22-70
- At least 1 year post spinal cord injury
- Confirmed spinal cord injury per clinical history and ASIA criteria, documented by American Spinal Injury Association Impairment Scale (AIS)
- Incomplete injury grade ASIA C or D with ability to stand with support and some voluntary leg function
- Maximum walking capacity at or below WISCI-II level 9
- Injury level at thoracic vertebra 10 (T10) or above
- Ability to stand with moderate body weight support for at least 5 minutes
- Stable medical and physical condition
- Willingness and ability to commit to training and evaluation sessions over 6 months and longer follow-up
You will not qualify if you...
- Moderate to severe depression with Beck Depression Inventory II score 25 or higher
- Cognitive impairment with Mini-Mental State Examination score below 24
- Alcohol use disorder with AUDIT score 8 or higher
- Substance abuse with DAST-10 score 6 or higher
- Major medical co-morbidities or surgical contraindications such as coagulopathy
- Berg Balance score less than 21
- History of traumatic brain injury, seizures, severe autonomic dysreflexia, dysphagia, or osteoporosis
- Previous intracranial surgery or known brain lesions
- Need for diathermy, repetitive transcranial magnetic stimulation, electroconvulsive therapy, or serial brain MRIs
- Presence of non-MRI compatible metallic implants or other implantable devices affected by DBS
- Active implantable devices like pacemakers or defibrillators
- Pregnancy or desire to become pregnant during the study
- Breastfeeding
- Intractable orthostatic hypotension despite treatment
- Recent limb fracture, ligament injury, active pressure sores, or unstable skin conditions such as skin grafts or chest tubes
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The Miami Project to Cure Paralysis
Miami, Florida, United States, 33136
Actively Recruiting
2
University of Miami School Of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
B
Brian R Noga, Ph.D.
CONTACT
L
Letitia Fisher, BLA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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