Testosterone and Neural Function in Spinal Cord Injury

This study is looking at how a single dose of testosterone might affect nerve function in men with spinal cord injury (SCI). Many men with SCI have low testosterone, which can impact their brain health and how their body's automatic systems (like heart rate and blood pressure, called the autonomic nervous system or ANS) work. Researchers will give participants either Natesto testosterone intranasal gel or Ayr Saline Nasal Gel. They will then measure nerve responses using electromyography (EMG) to see if testosterone changes how nerves function. To join, you must be a man aged 18-80 with a spinal cord injury, and have low testosterone levels (hypogonadal) with related symptoms. The study plans to enroll 15 participants.

Study design: This is an interventional study with a planned enrollment of 15 male participants. The phase of the study is not specified.
What's involved: You would receive a single dose of either Natesto testosterone intranasal gel or Ayr Saline Nasal Gel. Nerve responses will be measured for up to one day.
Compensation: Not stated in the trial record.
Follow-up: Nerve responses will be measured for up to one day after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Testosterone and Neural Function

Recruiting

EARLY_PHASE1Ages 18–80InterventionalTreatment

VA Office of Research and Development

~15 participants

Updated 2026-01-09 on ClinicalTrials.gov

What's tested:Natesto testosterone intranasal gelAyr Saline Nasal Gel

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Electromyographic (EMG) responses

Measured over up to one day

Conditions

Spinal Cord Injury

Where it's being run

1 sites across 1 states

New York1

Study leadership

Jacob A Goldsmith, PhD · PRINCIPAL_INVESTIGATOR · James J. Peters Veterans Affairs Medical Center

Who to contact

Jacob A Goldsmith, PhD

[email protected]

(718) 584-9000

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Electromyographic (EMG) responsesup to one day
Response to electrical and magnetic stimulation, singly, will be measured via peak-to-peak amplitude (millivolts) in first dorsal interosseous and abductor pollicis brevis muscles.

Trialytics