Clinical Trial

Transformation of Paralysis to Stepping

Active, Not Recruiting Early Phase 1
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Summary
The main goal of the project is to develop multiple noninvasive neuromodulatory strategies to facilitate full weight bearing stepping overground in people with paralysis. We will determine the effectiveness of combining noninvasive spinal cord stimulation and the administration of buspirone (a monoaminergic agonist) in facilitating locomotor activity in a gravity-neutral apparatus, during body weight supported stepping on a treadmill, when stepping overground, or during full weight bearing stepping overground in a rolling walker. Our objective is to identify the experimental variables that define the efficacy of these novel neuromodulatory techniques over a 5 year period in 15 participants with severe spinal cord injury who are at least one year post-injury.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2019-09-25; most recent amendment 2026-03-11.
Status change: Recruiting → Active, Not Recruiting 2024-09-25
Status change: Not Yet Recruiting → Recruiting 2020-03-23
Trial Details
NCT Number NCT04105114
Lead Sponsor University of Louisville
Collaborators: National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Spinal Cord Injuries
Enrollment 15 participants
Start Date 2019-09-30
Primary Completion 2025-08-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-13