Transformation of Paralysis to Stepping
Running, not enrolling · Early Phase 1 · Has a placebo group
Conditions studied: Spinal Cord Injuries
In brief
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.
Key facts
- Study ID
- NCT04105114
- Run by
- University of Louisville
- People needed
- 15
- Starts
- 2019-09-30
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-03-13
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Untreated pressure sores,
- Unhealed bone fractures,
- Untreated active urinary tract infections,
- Peripheral lower limb neuropathies unrelated to SCI,
- Seizure disorders,
- Cardiopulmonary disease unrelated to SCI,
- Untreated anemia,
- Ventilator dependency,
- Female participants: Pregnant or planning to become pregnant during the time course of study, or nursing,
- Healing wounds/surgical sites along the spine, levels T9-L5,
- Anti-spasticity implantable pumps,
- Untreated clinically significant depression, psychiatric disorders, or ongoing drug abuse,
- Colostomy bag, urostomy,
- Individuals with abnormal blood panel results related to hepatic function, Individuals with abnormal estimated glomerular filtration rate (eGFR) and increase Creatinine Clearance (CrCl) levels above the normal range,
- Individuals unwilling or unable to wean from drug(s) that interact(s) with buspirone, such as: Monoamine oxidase inhibitors (MAOIs) - Selegiline (Emsam), Isocarboxazid (Marplan), Phenelzein (Nardil), and Tranylcypromine (Parnate).
Where it is running
- Frazier Rehabilitation and Neuroscience Institute — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.