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

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).