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NCT04105114 · ClinicalTrials.gov registry record · Early Phase 1
Transformation of Paralysis to Stepping
A Early Phase 1 study of Spinal Cord Injuries, sponsored by University of Louisville.
- Active
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT04105114: Active Early Phase 1 study of Spinal Cord Injuries, sponsored by University of Louisville.
NCT04105114 is a Early Phase 1 study of Spinal Cord Injuries that is active but no longer recruiting, run by University of Louisville. The registered enrollment target is 15 participants, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04105114, a Early Phase 1 study of Spinal Cord Injuries, is active but no longer recruiting, sponsored by University of Louisville.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Assessment of muscle activity, measured by electromyography, while the leg is suspended in a gravity neutral position.
Conditions Studied
Interventions
- DRUG Buspirone
- DEVICE Non-invasive Spinal Cord Stimulation
- DEVICE Overground stepping
- DEVICE Gravity Neutral Device
- DEVICE Body Weight Supported Treadmill Training
Study Locations (1)
Kentucky
- Frazier Rehabilitation and Neuroscience Institute - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2027-12-31 |
| Phase | Early Phase 1 |
What the registry record for NCT04105114 still lists
NCT04105114 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Spinal Cord Injuries appearing as the primary indexed condition, and to 5 interventions - of which Buspirone is the first listed.
NCT04105114 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT04105114 about?
NCT04105114 is a clinical study titled "Transformation of Paralysis to Stepping". 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 monoa...
What is the current status of trial NCT04105114?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2019-09-30. Estimated completion is 2027-12-31.
What conditions does trial NCT04105114 study?
This clinical trial studies the following conditions: Spinal Cord Injuries.
What interventions are being tested in trial NCT04105114?
The interventions under investigation include: Buspirone (DRUG), Non-invasive Spinal Cord Stimulation (DEVICE), Overground stepping (DEVICE), Gravity Neutral Device (DEVICE), Body Weight Supported Treadmill Training (DEVICE).
Who is sponsoring clinical trial NCT04105114?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04105114 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injuries
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04105114's enrollment target sits among peer trials
15 151st of 202 higher than 45 of 202 other Spinal Cord Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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