RECRUITING

Testosterone and Neural Function

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-01
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06130449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-80 years
  2. * Time since injury (TSI) more than 12 months
  3. * Traumatic or non-traumatic SCI
  4. * American Spinal Injury Association (ASIA) Injury classification Scale (AIS) A, B, C, or D
  5. * Stable prescription medication regimen for at least 30 days
  6. * Not currently receiving pharmacological treatment for hypogonadism
  7. * Must be able to commit to study requirements of 3 visits within a 30-day period
  8. * Provide informed consent
  1. * Extensive history of seizures
  2. * Ventilator dependence or patent tracheostomy site
  3. * History of neurologic disorder other than SCI
  4. * History of moderate or severe head trauma
  5. * Currently receiving treatment for hypogonadism
  6. * History of allergy, hypersensitivity, or other significant adverse reaction to testosterone replacement therapy
  7. * Significant cardiovascular disease or cardiac conduction disease
  8. * Active psychological disorder
  9. * Moderate or severe brain injury, stroke, tumor, multiple sclerosis, or abscess
  10. * Recent history (within 3 months) of substance abuse
  11. * Pressures sores stage 3 or greater
  12. * Active infection
  13. * Frequent severe migraines
  14. * 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)
  15. * 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
  16. * Use of medications that significantly lower seizure threshold, such as amphetamines, neuroleptics, dalfampridine, and bupropion.

Contacts and Locations

Study Contact

Jacob A Goldsmith, PhD
CONTACT
(718) 584-9000
Jacob.Goldsmith@va.gov
Noam Y Harel, MD PhD
CONTACT
(718) 584-9000
Noam.Harel@va.gov

Principal Investigator

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

Study Locations (Sites)

James J. Peters VA Medical Center, Bronx, NY
Bronx, New York, 10468-3904
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • spinal cord injury
  • testosterone
  • cardiovascular
  • neurophysiology
  • central nervous system
  • autonomic
  • motor function
  • electrical stimulation

Additional Relevant MeSH Terms

  • Spinal Cord Injury