NCT07109804 Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury
| NCT ID | NCT07109804 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Miami |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2026-10-30 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6 participants in total. It began in 2026-10-30 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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).
Contact & Investigator
Brian R Noga, PhD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT07109804 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 70 Years, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07109804 currently recruiting?
Yes, NCT07109804 is actively recruiting participants. Contact the research team at BNoga@med.miami.edu for enrollment information.
Where is the NCT07109804 trial being conducted?
This trial is being conducted at Miami, United States, Miami, United States.
Who is sponsoring the NCT07109804 clinical trial?
NCT07109804 is sponsored by University of Miami. The principal investigator is Brian R Noga, PhD at University of Miami. The trial plans to enroll 6 participants.