Effects of testosterone on nerve function in men with spinal cord injury
The Role of Androgens in Neurophysiological and Autonomic Function in Male Veterans With Spinal Cord Injury
This study tests if a single dose of intranasal testosterone can help improve nerve function in men with spinal cord injuries who have low testosterone levels.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT06130449 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a single dose of intranasal testosterone on motor and autonomic nervous system (ANS) function in men with spinal cord injury (SCI) who exhibit low testosterone levels. Given that low testosterone is prevalent in this population and may worsen nerve and ANS dysfunction, the study aims to evaluate whether testosterone replacement therapy can improve these functions. Participants will be male, hypogonadal individuals aged 18-80 with a history of SCI, and they will undergo three visits within a 30-day period to assess the effects of the treatment. The study is the first of its kind to explore the neural effects of intranasal testosterone in this specific patient group.
Who should consider this trial
Good fit: Ideal candidates are males aged 18-80 with a traumatic or non-traumatic spinal cord injury and low testosterone levels.
Not a fit: Patients who are currently receiving treatment for hypogonadism or have significant cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved nerve and autonomic function in men with spinal cord injury, enhancing their overall health and quality of life.
How similar studies have performed: While studies have shown testosterone's benefits in other populations, this specific approach in men with spinal cord injury is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
The Bronx, New York
- James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jacob A Goldsmith, PhD — James J. Peters Veterans Affairs Medical Center
- Study coordinator: Jacob A Goldsmith, PhD
- Email: Jacob.Goldsmith@va.gov
- Phone: (718) 584-9000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.