Thinking of joining a study?

Register your interest

Become a volunteer?

NCT07109804 | RECRUITING | Spinal Cord Injuries

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

University of Miami

Information provided by (Responsible Party):

Brian Ronald Noga

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

Condition or disease

Spinal Cord Injuries

Intervention/treatment

Deep Brain Stimulation (DBS)

Deep Brain Stimulation (DBS) Device Implant Procedure

Training Sessions

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 6 participants
Masking : NONE
Primary Purpose : DEVICE_FEASIBILITY
Official Title : Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury
Actual Study Start Date : 2025-11-30
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 22 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 8 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).
Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury

Location Details

NCT07109804

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

The Miami Project to Cure Paralysis

Miami, florida, United States, 33136

RECRUITING

United States, Florida

University of Miami School Of Medicine

Miami, florida, United States, 33136