The Role of Androgens in Neurophysiological and Autonomic Function in Male Veterans with Spinal Cord Injury

Background

This study focuses on the immediate (i.e., 30 minutes after a single dose) and short-term (i.e., one month of daily administration) effects of intranasal testosterone replacement therapy (iTRT) on restoration of central nervous system (CNS) excitability and cardiovascular function in men with chronic spinal cord injury (SCI) and Amyotrophic lateral sclerosis (ALS) compared to uninjured volunteers. Additionally, we will examine the relationships among testosterone concentrations, neural function, and cardiovascular function. The iTRT has already gained U.S. Food and Drug Administration (FDA) approval.

 

Brain Stimulation with Neuronavigation
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 you should 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
Dylan Arnero

Clinicaltrials.gov Identifier

NCT06130449

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