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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorUniversity of Miami

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Deep Brain Stimulation (DBS)
  • Deep Brain Stimulation (DBS) Device Implant Procedure
  • Training Sessions

Treatment groups

6 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Miami

Lead sponsor

The Miami Project to Cure Paralysis

Collaborator

Florida

Collaborator