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Testosterone and Neural Function - Trial NCT06130449

Access comprehensive clinical trial information for NCT06130449 through Pure Global AI's free database. This Phase 1 trial is sponsored by VA Office of Research and Development and is currently Not yet recruiting. The study focuses on Spinal Cord Injury. Target enrollment is 15 participants.

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NCT06130449
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06130449
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Testosterone and Neural Function
The Role of Androgens in Neurophysiological and Autonomic Function in Male Veterans With Spinal Cord Injury

Study Focus

Spinal Cord Injury

Natesto testosterone intranasal gel

Interventional

drug

Sponsor & Location

VA Office of Research and Development

Bronx, United States of America

Timeline & Enrollment

Phase 1

Apr 01, 2024

Mar 31, 2026

15 participants

Primary Outcome

Electromyographic responses

Summary

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.

ICD-10 Classifications

Sequelae of injury of spinal cord
Other injury of lumbar spinal cord
Injury of spinal cord, level unspecified
Other and unspecified injuries of thoracic spinal cord
Other and unspecified injuries of cervical spinal cord

Data Source

ClinicalTrials.gov

NCT06130449

Non-Device Trial