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NCT03345576 · ClinicalTrials.gov registry record · Phase 2
Testosterone and Long Pulse Stimulation After SCI
A Phase 2 study of Spinal Cord Injury, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03345576: Completed Phase 2 study of Spinal Cord Injury, sponsored by VA Office of Research and Development.
NCT03345576 is a Phase 2 study of Spinal Cord Injury that has completed, run by VA Office of Research and Development. The registered enrollment target is 12 participants, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03345576, a Phase 2 study of Spinal Cord Injury, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Denervation following spinal cord injury (SCI) limits beneficial application of neuromuscular electrical stimulation (NMES). SCI with denervation results in extensive muscle atrophy that is accompanied with several cardio-metabolic health risks. The current proposal provides a novel intervention by examining the effects of long pulse width stimulation (LPWS) and testosterone replacement therapy (TRT) on restoring muscle size and leg lean mass after denervation in persons with SCI. This intervention will be rewarding for Veterans and Civilians with SCI who do not benefit from exercising their lower extremity muscles because denervation has limited the response to standard surface NMES. The investigators will study the biochemical mechanisms that contribute to changes in muscle size following this novel training. Combing both pharmaceutical and physical-therapeutic interventions will optimize restoration of muscle size after SCI.
Primary Outcome
Magnetic resonance imaging (MRI): The skeletal muscle area will be measured at baseline 6 months and 12 months after training (post-intervention).
Conditions Studied
Interventions
- DEVICE Testosterone and LPWS
- DRUG Testosterone and standard NMES
Study Locations (1)
Virginia
- Hunter Holmes McGuire VA Medical Center, Richmond, VA - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-07-01 |
| Est. Completion | 2023-11-30 |
| Phase | Phase 2 |
What the finished NCT03345576 record still lists
NCT03345576 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Spinal Cord Injury appearing as the primary indexed condition, and to 2 interventions - of which Testosterone and LPWS is the first listed.
NCT03345576 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT03345576 about?
NCT03345576 is a clinical study titled "Testosterone and Long Pulse Stimulation After SCI". Denervation following spinal cord injury (SCI) limits beneficial application of neuromuscular electrical stimulation (NMES). SCI with denervation results in extensive muscle atrophy that is accompanied with several cardio-metabolic health risks. The current proposal provides a novel intervention by ...
What is the current status of trial NCT03345576?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2018-07-01. Estimated completion is 2023-11-30.
What conditions does trial NCT03345576 study?
This clinical trial studies the following conditions: Spinal Cord Injury.
What interventions are being tested in trial NCT03345576?
The interventions under investigation include: Testosterone and LPWS (DEVICE), Testosterone and standard NMES (DRUG).
Who is sponsoring clinical trial NCT03345576?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03345576 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injury
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 NCT03345576's enrollment target sits among peer trials
12 73rd of 99 higher than 21 of 99 other Spinal Cord Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injury 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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