Effects of testosterone on nerve function in men with spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of a single dose of intranasal testosterone on motor and autonomic nervous system (ANS) function in men with spinal cord injury (SCI) who exhibit low testosterone levels. Given that low testosterone is prevalent in this population and may worsen nerve and ANS dysfunction, the study aims to evaluate whether testosterone replacement therapy can improve these functions. Participants will be male, hypogonadal individuals aged 18-80 with a history of SCI, and they will undergo three visits within a 30-day period to assess the effects of the treatment. The study is the first of its kind to explore the neural effects of intranasal testosterone in this specific patient group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male
* Hypogonadal (Serum Total T \<300 nanograms per deciliter (ng/dL), Free T \<46 picograms per milliliter (pg/mL), or bioavailable T \<110 ng/dL) with signs/symptoms of hypogonadism
* Traumatic or non-traumatic spinal cord injury (SCI)
* Time since injury (TSI) more than 12 months
* American Spinal Injury Association (ASIA) Injury classification Scale (AIS) A, B, C, or D
* Stable prescription medication regimen for at least 30 days
* Not currently receiving pharmacological treatment for hypogonadism
* Must be able to commit to study requirements of 3 visits within a 30-day period
* Provide informed consent

Exclusion Criteria:

* Extensive history of seizures
* Ventilator dependence or patent tracheostomy site
* History of neurologic disorder other than spinal cord injury (SCI)
* History of moderate or severe head trauma
* Currently receiving treatment for hypogonadism
* History of allergy, hypersensitivity, or other significant adverse reaction to testosterone replacement therapy
* Significant cardiovascular disease or cardiac conduction disease
* Active psychological disorder
* Moderate or severe brain injury, stroke, tumor, multiple sclerosis, or abscess
* Recent history (within 3 months) of substance abuse
* Pressures sores stage 3 or greater
* Active infection
* Frequent severe migraines
* Recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolic pressure greater than 10 millimeters of mercury (mm Hg), without rise in heart rate, accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, and blurry vision (this will be closely monitored during all screening and testing procedures)
* History of implanted devices with electromagnetic properties: brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants in the head (except for inside mouth); cochlear implants; cardiac pacemaker/defibrillator; intracardiac lines; currently increased intracranial pressure; or other contraindications to brain or spine stimulation
* Use of medications that significantly lower seizure threshold, such as amphetamines, neuroleptics, dalfampridine, and bupropion

Where it's running

• James J. Peters VA Medical Center, Bronx, NY
  The Bronx, New York, United States Recruiting

Study contacts

• Principal investigator: Jacob A Goldsmith, PhD — James J. Peters Veterans Affairs Medical Center
• Study coordinator: Jacob A Goldsmith, PhD
• Email: Jacob.Goldsmith@va.gov
• Phone: (718) 584-9000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.