Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury
2 other identifiers
interventional
6
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2026
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2025
CompletedFirst Posted
Study publicly available on registry
August 7, 2025
CompletedStudy Start
First participant enrolled
June 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
Study Completion
Last participant's last visit for all outcomes
December 31, 2026
April 23, 2026
April 1, 2026
6 months
July 31, 2025
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in walking speed measured by 10-meter walk test
The ten-meter walk test will be measured in meters/second.
baseline, up to 34 weeks
Change in distance measured by 6-min walk test
The 6-min walk test will be measured in meters
baseline, up to 34 weeks
Study Arms (1)
Deep Brain Stimulation (DBS)
EXPERIMENTALParticipants will be in the DBS study group for up to 34 weeks.
Interventions
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.
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 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).
Eligibility Criteria
You may qualify if:
- Male or female subjects between ages of 22-70
- At least 1 year post SCI
- Confirmed SCI according to SCI clinician according to clinical history and the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) / American Spinal Injury Association (ASIA) criteria as documented in the American Spinal Injury Association Impairment Scale (AIS) on examination. Other disorders of gait will be excluded by history and a neurological examination.
- Persons with incomplete injury grades of ASIA C or D who can stand with support and who have some voluntary leg function and a maximum walking capacity of Walking Index for spinal cord injury - level II (WISCI-II) level 9 or less.
- Injury level T10 and above.
- Ability to stand with moderate body weight support for at least 5 minutes.
- Stable medical and physical condition.
- Able to commit to training/evaluation sessions over 6 months and for longer periodic follow-up.
You may not qualify if:
- Individuals with high-moderate to severe depression -Beck Depression Inventory II (BDI II) ≥ 25).
- Individuals with cognitive impairment indicated by a score of less than 24 on the Folstein Mini-Mental State Examination 2nd ed. (MMSE).
- Individuals with alcohol use disorder. The Alcohol Use Disorder Identification Test (AUDIT) will be used to measure harmful patterns of alcohol consumption over the past year. A cutoff score of 8 will be used to identify and exclude those with moderate to severe alcohol use behavior.
- Individuals with substance abuse. The Drug Abuse Screening Test (DAST-10) will be used to identify problematic substance abuse behavior over the past year. A cutoff score of 6 will be used to identify and exclude those with moderate to severe drug use behavior.
- The presence of major medical co-morbidities and other surgical contra-indications such as coagulopathy as defined by past medical history and abnormal lab work at the investigator/surgeon's discretion.
- Individuals with a Berg Balance score \< 21.
- Individuals with a history of traumatic brain injury (TBI), seizures, severe autonomic dysreflexia, dysphagia or osteoporosis.
- History of prior intracranial surgery or known lesions.
- Individuals that require diathermy, repetitive transcranial magnetic stimulation, electroconvulsive therapy, or serial brain MRIs.
- Individuals with non-MRI compatible metallic implants in their head or body, and with metallic implants and other implantable devices in the body that could be affected by DBS.
- Individuals with active implantable devices anywhere in the body (e.g., cardiac pacemaker, defibrillator, implanted medication pump).
- Individuals who are pregnant desire to become pregnant during the study.
- Individuals who are breastfeeding.
- Individuals with intractable orthostatic hypotension despite treatment.
- Individuals with a recent history of limb fracture, ligamentous injury, active pressure sores or unstable skin structures (e.g., skin grafts and chest tubes).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- The Miami Project to Cure Paralysiscollaborator
- Floridacollaborator
Study Sites (2)
The Miami Project to Cure Paralysis
Miami, Florida, 33136, United States
University of Miami School Of Medicine
Miami, Florida, 33136, United States
Related Publications (1)
Hofer AS, Scheuber MI, Sartori AM, Skorup I, Gascho D, Colacicco G, Kiseleva A, Curt A, Stieglitz LH, Schwab ME. Stereotactic rodent-to-human approximation of the mesencephalic cuneiform nucleus to guide deep brain stimulation. Brain Stimul. 2026 Mar-Apr;19(2):103066. doi: 10.1016/j.brs.2026.103066. Epub 2026 Mar 3.
PMID: 41786287DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian R Noga, PhD
University of Miami
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 31, 2025
First Posted
August 7, 2025
Study Start (Estimated)
June 30, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share