Testosterone and long pulse width stimulation (TLPS) for denervated muscles after spinal cord injury: a study protocol of randomised clinical trial

BMJ Open, 2022 · DOI: 10.1136/bmjopen-2022-064748 · Published: September 14, 2022

Spinal Cord Injury Endocrinology Neurology

Simple Explanation

This study investigates whether testosterone treatment (TT) combined with long pulse width stimulation (LPWS) can help restore muscle size and improve metabolic health in individuals with spinal cord injury (SCI) who have denervated muscles. The study will involve 24 male participants with chronic SCI who will be randomly assigned to receive either TT+LPWS or TT+standard neuromuscular electrical stimulation. Researchers will measure muscle size, body composition, and metabolic profiles before, during, and after the 1-year training period to assess the effectiveness of the TT+LPWS treatment.

Study Duration

1 year

Participants

Twenty-four male participants (aged 18–70 years with chronic SCI)

Evidence Level

Level 1, randomised clinical trial

Key Findings

1
The study hypothesizes that TT+LPWS will upregulate protein synthesis pathways, downregulate protein degradation pathways, and increase overall mitochondrial health in denervated muscles.
2
The goal is to determine if the combination of TT and LPWS can lead to a significant increase in knee extensor muscle size and leg lean mass, along with improvements in cardiometabolic health.
3
The study will also investigate cellular mechanisms responsible for muscle hypertrophy by measuring protein and mRNA expressions.

Research Summary

This study protocol outlines a randomized clinical trial to investigate the effects of testosterone treatment (TT) combined with long pulse width stimulation (LPWS) on denervated muscles in individuals with spinal cord injury (SCI). The primary aim is to determine if TT+LPWS can increase skeletal muscle size, leg lean mass, and improve metabolic health compared to TT+standard neuromuscular electrical stimulation. The trial will involve comprehensive measurements of body composition, metabolic profiles, and cellular mechanisms to assess the effectiveness of the intervention and understand the underlying biological processes.

Practical Implications

Rehabilitation Strategy

The trial aims to develop a novel rehabilitation strategy to mitigate muscle loss following LMN denervation by combining TT and LPWS.

Clinical Translation

If proven successful, the intervention will be translated into clinical practice for persons with SCI, improving their quality of life.

Targeted Interventions

Understanding the cellular mechanisms involved may allow for the design of specific interventions that target abnormalities at the cellular level, impacting body composition and metabolic adaptations.

Study Limitations

1
Recruitment and retaining for a duration of 12 months is rather challenging in this subpopulation with SCI.
2
Currently, LPWS stimulators are not clinically or commercially available in North America.
3
COVID-19 amplified the limitations in terms of finding, recruiting, working with and transporting participants.

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