Recruiting

CnF DBS

Sponsor:

University of Miami

Code:

NCT07109804

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 22 - 70

Healthy Volunteers: Not accepted

Interventions

Deep Brain Stimulation (DBS)

Deep Brain Stimulation (DBS) Device Implant Procedure

Training Sessions

Study Details

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

Conditions

Spinal Cord Injuries

Study ID

NCT07109804

Start date

Oct 30, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Deep Brain Stimulation (DBS)

Participants will be in the DBS study group for up to 34 weeks.

Interventions

Deep Brain Stimulation (DBS)

The DBS system delivers electrical current into deep areas of the brain. In this study, the electrical current will be delivered continuously during the study duration to an area of the brain called the cuneiform nucleus (CnF). Stimulation frequencies are anticipated to be between 20 and 50 Hertz. Participants may choose to continue stimulation following study termination. This area of the brain is associated with the body's ability to start a movement.

Deep Brain Stimulation (DBS) Device Implant Procedure

Participants will undergo a one-time implantation of Cartesia DBS electrodes (bilateral) including the Vercise pulse generator in a single surgery (up to approximately 6 hours) to implant bilateral directional DBS leads in the cuneiform nucleus.

Training Sessions

Training sessions occurs 3 times/week at the study center to condition the subjects before DBS implantation and after DBS implantation. Each session may last up to 60 minutes. Training sessions include joint mobility (passive stretching), volitional neuromuscular activation (active hip mobility), task isolation (weight shifting), task integration (stepping), and activity rehearsal (walking).

Primary outcome measure

  • Change in walking speed measured by 10-meter walk test [ Time Frame: baseline, up to 34 weeks ]
  • Change in distance measured by 6-min walk test [ Time Frame: baseline, up to 34 weeks ]

Central Contacts and Locations

Central contacts

Brian R Noga, Ph.D.

305-243-6155BNoga@med.miami.edu

Letitia Fisher, BLA

305-243-3056lfisher@med.miami.edu

Locations

The Miami Project to Cure Paralysis

Recruiting

Miami, Florida, United States, 33136

Contacts

Letitia Fisher, BLA

3052433056lfisher@miami.edu

David McMillan, PhD

305-243-5569dmcmillan1@med.miami.edu

Principal Investigator:

Brian Noga, PhD

University of Miami School Of Medicine

Recruiting

Miami, Florida, United States, 33136

Contacts

Brian R Noga, PhD

305-243-6155BNoga@med.miami.edu

Letitia FISHER, BLA

305-243-3056lfisher@miami.edu

Principal Investigator:

Brian R Noga, PhD

More Information

Sponsor

University of Miami

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • Spinal Cord Injury
  • deep brain stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-06-12.