CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Testosterone and standard NMES +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03345576
NCT03345576Phase 2Completed
CompareCT.gov

Testosterone and Long Pulse Width Stimulation for Denervated Muscles After Spinal Cord Injury

VA Office of Research and Development·interventional·Posted Nov 17, 2017·Updated Oct 14, 2025

In Brief

A Phase 2 clinical trial evaluating Testosterone and LPWS and Testosterone and standard NMES for Spinal Cord Injury. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Cord Injury
CountriesUnited States
CollaboratorsHunter Holmes McGuire VA Medical Center

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 17, 2017
Enrollment StartJul 1, 2018
Primary CompletionJun 30, 2023
Study CompletionNov 30, 2023
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 8.6 years ago

Interventions

Testosterone and LPWSdevice

Twelve patients will undergo 1 year of supervised training examining the effects of testosterone replacement therapy (TRT) and long pulse width stimulation (LPWS) in persons with denervated spinal cord injury.

Testosterone and standard NMESdrug

Twelve patients will undergo 1 year of supervised training examining the effects of testosterone replacement therapy (TRT) and standard surface neuromuscular electrical stimulation (NMES) in persons with denervated spinal cord injury.