Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury

Recruiting now · Phase 2

Conditions studied: Spinal Cord Injury, Spinal Cord Injuries, Trauma, Nervous System, Wounds and Injury, Central Nervous System Diseases, Spinal Cord Diseases, Gonadal Disorders, Endocrine System Diseases, Hypogonadism, Genital Diseases, Male, Spinal Cord Trauma, Injuries, Spinal Cord, Walking, Difficulty, Gait Disorders, Neurologic, Locomotion Disorder, Neurologic, Wounds and Injuries, Nervous System Diseases, Testosterone Deficiency, Androgen Deficiency, Hormone Deficiency

In brief

This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.

Key facts

Study ID

NCT04460872

Run by

North Florida Foundation for Research and Education

People needed

21

Starts

2021-01-31

Expected to finish

2026-06-30

Last updated by the study team

2025-05-06

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Men >18 years of age
• Diagnosis of an incomplete SCI involving spinal segments L1 or above or a clinically complete SCI involving spinal segments T2-L1, with upper motor neuron injury signs (i.e., spasticity, hypertonicity) for >60-days
• Low serum total testosterone (<300 ng/dL), bioavailable testosterone (<110 ng/dL), or free testosterone (<46 pg/mL or <4.6 ng/dL)
• Presence of one or more sign or symptom that may be related to low testosterone, including: loss of body hair or reduced shaving, very small testes (<6 mL), reduced sexual desire (libido) and activity, decreased spontaneous erections (e.g., morning erections) or erectile dysfunction, breast discomfort or gynecomastia, height loss, low-trauma fracture, or low BMD, hot flushes or sweats, decreased energy, motivation, initiative, or self-confidence, fatigue or irritability, feeling sad or blue, having a depressed mood, or having a persistent low-grade depressive disorder, poor concentration or memory, sleep disturbances or increased sleepiness, mild unexplained anemia (normochromic or normocytic), reduced muscle bulk, strength, or physical performance, Increased body fat or body mass index, any other sign or symptom commonly associated with low testosterone
• Locomotor dysfunction, definted as self-selected walking pace ≤1.0 m/s on a 10mWT, either with or without gait devices or braces and with or without assistance, or as self-selected walking pace >1.0 m/s with reliance on a gait device or brace or with highly compensated movement impairments, as identified by a trained observer.
• Diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology
• Medically-stable condition that is asymptomatic for conditions that will interfere with the study participation
• Willingness to administer TRT as instructed by the study staff and to abide by study protocol
• Documented approval from the study physician verifying medical status

You may not qualify if…

• Currently participating in another research protocol that may influence study outcomes.
• Mental state that precludes understanding the study protocol.
• Life expectancy <12-months.
• History of or current congenital SCI (e.g., Chiari malformation, myelomeningocele, intraspinal neoplasm, Frederich's ataxis) or other degenerative spinal disorder (e.g., spinocerebellar degeneration) that may complicate study procedures
• Multiple sclerosis, amyotrophic lateral sclerosis, or other neurologic impairment or injury
• Current prostate, breast, or other organ cancer or a history of prostate or breast cancer
• Any other diagnosed or treated cancer within the past 24-months, with the exceptions of basal or squamous cell carcinoma of the skin that has been successfully treated
• Serum prostate-specific antigen (PSA) >3.0 ng/mL [men treated with 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are eligible to participate if PSA values are ≤1.5 ng/mL]
• Prostate nodule or induration noted on digital rectal exam (DRE) during screening that tests positive for prostate cancer
• Currently seeking fertility or expected during the duration of the study
• Gynecomastia
• Hematocrit (HCT) >49%
• Any major cardiovascular (CV) event within the last 12-months (defined as a history of acute myocardial infarction, any cardiac revascularization procedure including angioplasty, stenting, or coronary artery bypass grafting, revascularization of the carotid or middle cerebral artery or procedures to treat critical limb ischemia, or hospitalization due to unstable angina, transient ischemic attack, stroke, or peripheral vascular disease)
• Angina that is not controlled on a current medical regimen (Canadian class II, III, or IV)
• Poorly compensated congestive heart failure (NYHA class III or IV)
• Poorly controlled hypertension (consistently measured systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg), while on medications
• Poorly controlled arrhythmia of any type
• Severe valvular heart disease
• Baseline electrocardiogram (ECG) findings such as left bundle branch block or marked ECG abnormalities that would preclude serial screening evaluations for occult ischemic events
• History of unprovoked deep venous thrombosis (DVT), unprovoked pulmonary embolism, history of recurrent DVT or known thrombophilia
• LDL cholesterol >160 mg/dL with history of any major CV event, defined above, within the last 12-months
• Major non-CV surgery (e.g., major abdominal or thoracic procedure) within 90-days prior to screening and/or a major surgery scheduled at the time of screening
• Liver enzymes (AST or ALT) >1.5 times the normal upper limit
• Severe or end-stage chronic kidney disease documented by estimated glomerular filtration rate (eGFR) <30 mL/min
• Diagnosed, but untreated severe obstructive sleep apnea

Where it is running

• North Florida/South Georgia Veterans Health System — Gainesville, Florida, United States (enrolling)
• Brooks Rehabilitation — Jacksonville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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