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NCT05008484 · ClinicalTrials.gov registry record · Phase 2
Effects of Electrical Stimulation and Vitamin D Supplementation on Bone Health Following Spinal Cord Injury.
A Phase 2 study of Spinal Cord Injury, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT05008484: Completed Phase 2 study of Spinal Cord Injury, sponsored by VA Office of Research and Development.
NCT05008484 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 6 participants, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05008484, 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
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
Neurogenic osteoporosis is a common complication of spinal cord injury (SCI) that is associated with low impact bone fractures. It is concerning that more than 46,000 Veterans affected with SCI and are at risk of osteoporosis and possible low impact fractures. About fifty percent of all individuals with SCI will develop low impact fracture in their life time. The management of osteoporosis-related fractures can impose substantial economic burden on the health care system, the individual and the families. Previous studies did not succeed in reversing the process of bone loss after SCI. In the present pilot study, we will evaluate the effect of Neuromuscular Electrical Stimulation Resistance Training in combination with oral Vitamin D supplementation, on bone quality in Veterans with chronic SCI, using a randomized experimental design.
Primary Outcome
The outcome measure was trabecular plate width expressed in μm, as measured by a non-contrast magnetic resonance imaging (MRI) of the femur and tibia. A trained radiology technician performed the MRI using a 3.0T magnet (GE Discovery MR750 software, version: DV24 System 804675VA3T; GE Waukesha, WI). A specific knee coil with a 3D fast-spin gradient echo (10 min) sequence was used to obtain high-resolution images (20-22 FOV). A bilateral phased array coil (USA Instruments) was used to collect 30
Conditions Studied
Interventions
- DEVICE NMES
- DRUG Vitamin D
- BEHAVIORAL Passive movement
Study Locations (1)
Virginia
- Hunter Holmes McGuire VA Medical Center, Richmond, VA - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2024-06-13 |
| Phase | Phase 2 |
What the finished NCT05008484 record still lists
NCT05008484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Spinal Cord Injury appearing as the primary indexed condition, and to 3 interventions - of which NMES is the first listed.
NCT05008484 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT05008484 about?
NCT05008484 is a clinical study titled "Effects of Electrical Stimulation and Vitamin D Supplementation on Bone Health Following Spinal Cord Injury.". Neurogenic osteoporosis is a common complication of spinal cord injury (SCI) that is associated with low impact bone fractures. It is concerning that more than 46,000 Veterans affected with SCI and are at risk of osteoporosis and possible low impact fractures. About fifty percent of all individuals ...
What is the current status of trial NCT05008484?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2021-10-01. Estimated completion is 2024-06-13.
What conditions does trial NCT05008484 study?
This clinical trial studies the following conditions: Spinal Cord Injury.
What interventions are being tested in trial NCT05008484?
The interventions under investigation include: NMES (DEVICE), Vitamin D (DRUG), Passive movement (BEHAVIORAL).
Who is sponsoring clinical trial NCT05008484?
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 NCT05008484 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
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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 NCT05008484's enrollment target sits among peer trials
6 94th of 99 higher than 5 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.
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