Could a single dose of testosterone boost nerve function in spinal cord injury?
NCT ID NCT06130449
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study looks at how a single dose of intranasal testosterone affects nerve and autonomic function in 15 male veterans with spinal cord injury who have low testosterone. Researchers will measure muscle responses and heart rate changes before and after the dose. The goal is to understand if testosterone can improve nerve signaling and autonomic reflexes in this population.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- testosterone intranasal gel
- What this could lead to
- If it works, this could point toward a way to improve nerve and autonomic function in men with spinal cord injury.
- What could go wrong
- This is a very early, small study with only 15 participants. It tests a single dose, so any effects may be temporary or not translate to long-term benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male * Hypogonadal (Serum Total T \<300 ng/dL, Free T \<46 pg/mL, or bioavailable T \<110 ng/dL) with signs/symptoms of hypogonadism * Age 18-80 years * 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 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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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James J. Peters VA Medical Center, Bronx, NY
RECRUITINGThe Bronx, New York, 10468-3904, United States
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