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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 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.

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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.

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

FieldValue
Enrollment Target 12 participants
Start Date 2018-07-01
Est. Completion 2023-11-30
Phase Phase 2

Sponsor

VA Office of Research and Development

1,668 total trials

What the Registry Record Tells You About NCT03345576

The ClinicalTrials.gov registry entry for NCT03345576 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 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 (86% 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 2 interventions - of which Testosterone and LPWS is the first listed.

NCT03345576 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.