Deep brain stimulation of the cuneiform nucleus to improve walking after spinal cord injury

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

This trial will try deep brain stimulation of the cuneiform nucleus to improve walking in adults with incomplete spinal cord injuries who cannot walk effectively.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 22 Years to 70 Years
• Sex: All
• Sponsor: University of Miami (Academic / other)
• Locations: 2 sites (Miami, Florida and 1 other locations)
• Trial ID: NCT07109804 on ClinicalTrials.gov

What this trial studies

This interventional protocol implants a deep brain stimulation (DBS) device targeting the cuneiform nucleus (CnF) and pairs stimulation with intensive gait training to try to facilitate walking. Eligible participants will undergo surgical lead placement, post‑operative stimulation programming, and repeated training/evaluation sessions over a six‑month period with longer periodic follow-up. The study focuses on feasibility, safety, device tolerability, and preliminary effects on standing and overground walking capacity in people with incomplete SCI. Outcome measures include WISCI-II and other walking/standing metrics, along with adverse event monitoring.

Who should consider this trial

Good fit: Ideal candidates are adults 22–70 years old who are at least one year post incomplete (AIS C or D) spinal cord injury at T10 or above, can stand with support, have some voluntary leg function, have limited walking capacity (WISCI-II ≤9), and can commit to surgery and ongoing training and follow-up.

Not a fit: People with complete injuries (no voluntary leg function), injuries below T10, unstable medical conditions, or those unable to undergo surgery and intensive follow-up are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could restore meaningful overground walking or reduce reliance on assistance for some people with incomplete spinal cord injury.

How similar studies have performed: Preclinical studies and small human reports targeting the mesencephalic locomotor region (including the cuneiform nucleus and related areas) have shown promising effects on locomotion, but strong clinical evidence in spinal cord injury patients remains limited.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Where this trial is running

Miami, Florida and 1 other locations

• The Miami Project to Cure Paralysis — Miami, Florida, United States (Recruiting)
• University of Miami School Of Medicine — Miami, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Brian R Noga, PhD — University of Miami
• Study coordinator: Brian R Noga, Ph.D.

Conditions Spinal Cord Injuries; Spinal Cord Injury; deep brain stimulation