Is NCT04460872 recruiting in Jacksonville, FL?

Yes, NCT04460872 is currently recruiting participants at its Jacksonville, FL location. This spinal cord injury clinical trial is actively enrolling qualified participants.

How do I join the spinal cord injury clinical trial in Jacksonville?

To join this clinical trial in Jacksonville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Jacksonville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Spinal Cord Injury Clinical Trial in Jacksonville, FL

About This Spinal Cord Injury Study in Jacksonville

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 a

Sponsor: North Florida Foundation for Research and Education

Who Can Participate

Inclusion Criteria

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

Exclusion Criteria

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

Lower extremity fracture in the last 12-months (exclusion criterion for participation in LT+TRT group only)

Femoral neck, total hip, or lumbar spine t-score below -2.5 or distal femur BMD \<0.70 g/cm2, assessed via DEXA at screening (exclusion criterion for participation in LT+TRT group only)

Current anticoagulant therapy (contraindication for i.m. injections)

Use of any of the following pharmacologic agents in the previous 90-days: any TRT formulation, any compounded or over-the-counter androgenic hormones or androgen precursors, clomiphene, aromatase inhibitors, anti-estrogen or estrogen treatment, or growth hormone

Use of anti-resorptive or bone anabolic drug therapy in the previous 180-days

Acute use (\>5-days) of any opioids (e.g., oxycodone, hydrocodone, etc) or systemic glucocorticoids \>7.5 mg/d prednisone equivalent (e.g., hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg) within 1-week before screening visit, except men who are taking these medications for a chronic condition and are anticipated to continue treatment for the study duration

Known allergy to any component of the TRT formulation (e.g., sesame oil or cottonseed oil)

Any other condition, therapy, lab abnormality, medical or psychiatric conditions, or reason that might pose a risk to the participant, make participation not in the person's best interest, confound the study results (e.g., inability to comply with study requirements), make the participant unsuitable to receive study intervention, or interfere with the person's ability to participate for the entire study duration

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Jacksonville?

Yes, this clinical trial (NCT04460872) has an active research site in Jacksonville, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Spinal Cord Injury Treatment Options in Jacksonville, FL

If you're searching for spinal cord injury treatment options in Jacksonville, FL, this clinical trial (NCT04460872) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Jacksonville research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced spinal cord injury specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all spinal cord injury clinical trials near you to find additional studies recruiting in your area.

Spinal Cord Injury Clinical Trial in Jacksonville, FL

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