Testosterone and Neural Function

Drug
General health
Online since 25 February 2024, updated 118 days ago

About this trial

This trial is enrolling 15 male veterans with chronic spinal cord injury to test the feasibility of using testosterone on nerve and autonomic function. If included, participants will receive a single dose of testosterone, using a nasal gel, and, on a separate occasion, a single dose of a placebo gel. Final testing of central nervous system excitability (neurophysiology) and autonomic reflex function will be assessed after up to one day.

Included participants

Gender
Male
Age
18 - 80 years
Injury level
C1 - S5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 12 months
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    NOT have ventilator dependence or patent tracheostomy site
    NOT have implanted devices with electromagnetic properties
    NOT have a hitsory of other neurologic disorders or head trauma

    What’s involved

    Type

    Drug

    Details

    - Participants will receive a single dose of testosterone using a nasal gel - On a separate visit, their will receive a placebo gel. - The order of treatments will be blinded to the participant. - Final testing of motor and cardiovascular function will be assessed after 30 minutes - Testing of motor function will be assessed using transcranial magnetic stimulation (TMS). TMS is a non-invasive technique which uses a magnetic field to stimulate the brain. A coil (held over the head) delivers the magnetic stimulation that activates the central nervous system. Activation of muscles through TMS will be assessed using surface electrodes on the skin of the hands. - Cardiovascular function will be assessed using a cold face challenge.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Apr 2024
    • Organisation
    • VA Office of Research and Development
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Apr 2024
    • Organisation
    • VA Office of Research and Development

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more