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NCT03452007 · ClinicalTrials.gov registry record · NA
SPARC Bladder Mapping and Training Study
A NA study of Spinal Cord Injuries, sponsored by University of Louisville.
- Active
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03452007: Active NA study of Spinal Cord Injuries, sponsored by University of Louisville.
NCT03452007 is a NA study of Spinal Cord Injuries that is active but no longer recruiting, run by University of Louisville. The registered enrollment target is 10 participants, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03452007, a NA study of Spinal Cord Injuries, is active but no longer recruiting, sponsored by University of Louisville.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators propose to determine the electrode configurations that promote functional gains in the storage and voiding phases of lower urinary tract function as a result of activation of spinal circuits with spinal cord epidural stimulation in humans with spinal cord injury. The innovative approach and novel application of the Medtronic Specify 5-6-5 (16-electrode array) epidural device will allow the investigators to determine, with this early feasibility study, specific parameters of spinal cord epidural stimulation and approaches for bladder training needed for lower urinary tract function which will lay the groundwork for expedient translation of this promising technology to larger numbers of individuals with spinal cord injury who currently have limited treatment options. The current proposed study will increase the understanding of human lumbosacral spinal networks and guide the use of innovative therapeutic strategies that would be immediately available to not only improve the motor output during standing and walking but also ameliorate bladder dysfunction and thus improve quality of life in individuals after spinal cord injury.
Primary Outcome
The quantitative metric will be the percent changes in either residual volume (measured in ml) alone if no leak occurred or leak volume divided by leak plus residual volumes if a void occurred upon reaching capacity.
Conditions Studied
Interventions
- DEVICE Epidural Stimulation
Study Locations (1)
Kentucky
- University of Louisville - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-09-12 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What the registry record for NCT03452007 still lists
NCT03452007 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Spinal Cord Injuries appearing as the primary indexed condition, and to 1 intervention - of which Epidural Stimulation is the first listed.
NCT03452007 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT03452007 about?
NCT03452007 is a clinical study titled "SPARC Bladder Mapping and Training Study". The investigators propose to determine the electrode configurations that promote functional gains in the storage and voiding phases of lower urinary tract function as a result of activation of spinal circuits with spinal cord epidural stimulation in humans with spinal cord injury. The innovative app...
What is the current status of trial NCT03452007?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2018-09-12. Estimated completion is 2025-12-31.
What conditions does trial NCT03452007 study?
This clinical trial studies the following conditions: Spinal Cord Injuries.
What interventions are being tested in trial NCT03452007?
The interventions under investigation include: Epidural Stimulation (DEVICE).
Who is sponsoring clinical trial NCT03452007?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03452007 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 NCT03452007's enrollment target sits among peer trials
10 175th of 202 higher than 24 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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