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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 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.

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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.

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

FieldValue
Enrollment Target 6 participants
Start Date 2021-10-01
Est. Completion 2024-06-13
Phase Phase 2

Sponsor

VA Office of Research and Development

1,668 total trials

What the Registry Record Tells You About NCT05008484

The ClinicalTrials.gov registry entry for NCT05008484 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (93% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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