Actively Recruiting
Testosterone and Neural Function
Led by VA Office of Research and Development · Updated on 2026-01-09
15
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Spinal cord injury (SCI) disrupts the nerves controlling movement, along with those that regulate functions like heart rate and blood pressure (known as the autonomic nervous system, or ANS). Testosterone (T) plays a significant role in brain health and ANS reflex function in non-neurologically impaired men. However, little is known about the relationships between T, nerve function, and ANS dysfunction after SCI. Interestingly, up to 60% of men with SCI exhibit persistently low T concentrations, which may worsen nerve and ANS dysfunction. In uninjured eugonadal people (normal physiologic range of serum T concentrations), a single pharmacologic dose of intranasal T has been shown to quickly improve nerve function, but no study has evaluated if T administration alters nerve and ANS function in men with SCI. Herein, the investigators will conduct the first study to test how a single dose of intranasal T impacts motor and ANS function in this population.
CONDITIONS
Official Title
Testosterone and Neural Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male
- Hypogonadal with serum Total T <300 ng/dL, Free T <46 pg/mL, or bioavailable T <110 ng/dL and related signs or symptoms
- Age between 18 and 80 years
- Traumatic or non-traumatic spinal cord injury
- Time since injury more than 12 months
- American Spinal Injury Association (ASIA) Injury classification Scale A, B, C, or D
- Stable prescription medication regimen for at least 30 days
- Not currently receiving pharmacological treatment for hypogonadism
- Able to commit to 3 study visits within 30 days
- Provide informed consent
You will not qualify if you...
- Extensive history of seizures
- Ventilator dependence or patent tracheostomy site
- History of neurological disorder other than spinal cord injury
- History of moderate or severe head trauma
- Currently receiving treatment for hypogonadism
- History of allergy, hypersensitivity, or significant adverse reaction to testosterone replacement therapy
- Significant cardiovascular 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
- Pressure sores stage 3 or greater
- Active infection
- Frequent severe migraines
- Recent history (within 6 months) of recurrent autonomic dysreflexia
- History of implanted devices with electromagnetic properties or contraindications to brain or spine stimulation
- Use of medications that significantly lower seizure threshold such as amphetamines, neuroleptics, dalfampridine, and bupropion
AI-Screening
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Trial Site Locations
Total: 1 location
1
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, United States, 10468-3904
Actively Recruiting
Research Team
J
Jacob A Goldsmith, PhD
CONTACT
N
Noam Y Harel, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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