The Role of Androgens in Neurophysiological and Autonomic Function in Male Veterans with Spinal Cord Injury
Background
This study focuses on the short-term effects of a single dose of intranasal testosterone replacement
therapy on restoration and/or normalization of central nervous system (CNS) excitability and cardiovascular function in men with spinal cord injury (SCI). Additionally, we will examine the relationships between testosterone concentrations, neural, and cardiovascular function. The intranasal testosterone replacement therapy has already gained U.S. Food and Drug Administration (FDA) approval.
Eligibility Criteria (summary)
Age 18-80 years old men with chronic SCI (occurred greater than 12 months ago)
No history of severe traumatic brain injury (TBI), stroke, multiple sclerosis, Parkinson’s disease, or epilepsy
Other eligibility criteria will be screened in person to make sure it is safe for you to participate
Healthy, non-injured participants are welcome as well
Note: For your own safety, you will be required to give a small sample of blood during the screening
process, to ensure that your kidney, liver, and cardiovascular system are functioning normally prior to
administering any study drug.
Procedures
Up to 3 visits lasting up to 5 hours each.
What should you know
Electrical and magnetic stimulation can feel like a ‘shock’ that is temporarily uncomfortable at higher pulse strength.
The main risk of magnetic brain stimulation is seizure. BUT:
Seizures are riskier when pulses are given faster than once per second – in this study, pulses are never given more than once every 5 or 10 seconds
The exclusion criteria are designed to prevent anyone at risk of seizure from participating.
When performed according to these recommendations, the risk of seizure is less than 1 in 1,000.
If you are uncomfortable at any time for any reason, we can stop the procedures. There is no
obligation!!
Investigator
Jacob A. Goldsmith, PhD
Study ID
Intranasal TRT 1
Contact
Finn Fox and Ian Paez
Clinicaltrials.gov Identifier
NCT06130449