Testosterone and Long Pulse Stimulation After SCI

• Status: Recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborator: Hunter Holmes McGuire VA Medical Center
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Traumatic motor complete SCI and level of injury of T10 and below

• Only participants with lower motor neuron (LMN) denervation as determined by EMG testing

• Participants must also have an absence of reflexes, denervation of both knee extensor muscles

• Tolerance to LPWS paradigm

• Both knee extensors will also have to be unresponsive (i.e., no observed tetanic contraction or twitches) to standard electrical stimulation procedures (stimulation frequency: 30 Hz; pulse duration:450 s and amplitude of the current:200 mA)

• All participants will undergo International Standards for Neurological Classification of SCI (ISNCSCI) examination for neurological level and function and only those with American Spinal Injury Classification (AIS A and B; i.e. motor deficit below the level of injury)

Exclusion Criteria:

• Diagnosis of neurological injury other than SCI

• Pre-existing medical conditions will be excluded (cardiovascular disease, uncontrolled type II DM and those on insulin requirements) or other concurrent medical conditions judged to be contraindicated by the site physician.

• Hematocrit above 50% and severe urinary tract infection or symptoms

• Those with hyper-physiological testosterone level above 800 ng/dl

• Those who will fail to tolerate the LPWS paradigm

• Progressive condition that would be expected to result in changing neurological status

• Lower extremity fracture around the knee joint (distal femur or proximal tibia) within the last 2 years from enrollment in the study

• Knee BMD < 0.60 gm/cm2

• Total hip BMD T-scores < -3.5

• Untreatable severe spasticity judged to be contraindicated by the site Physician

• Untreated or uncontrolled hypertension (systolic blood pressure >140 mmHg; diastolic blood pressure >90 mmHg)

• Pressure ulcer of the trunk, pelvic area, or lower extremities of grade 3 or more

• Psychopathology documentation in the medical record or history that may conflict with study objectives