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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
The Miami Project to Cure Paralysis
RECRUITING
Miami
University of Miami School Of Medicine
RECRUITING
Miami
Contact Information
Primary
Brian R Noga, Ph.D.
BNoga@med.miami.edu
305-243-6155
Backup
Letitia Fisher, BLA
lfisher@med.miami.edu
305-243-3056
Time Frame
Start Date: 2025-11-30
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 6
Treatments
Experimental: Deep Brain Stimulation (DBS)
Participants will be in the DBS study group for up to 34 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: The Miami Project to Cure Paralysis, Florida
Leads: University of Miami

This content was sourced from clinicaltrials.gov