Health TrialsbyHealthPanel

Testosterone and Neural Function in Men With Spinal Cord Injury

ConditionSpinal Cord Injury
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18-80
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male

Hypogonadal (Serum Total T <300 nanograms per deciliter (ng/dL), Free T <46 picograms per milliliter (pg/mL), or bioavailable T <110 ng/dL) with signs/symptoms of hypogonadism

Traumatic or non-traumatic spinal cord injury (SCI)

Time since injury (TSI) more than 12 months

Disqualifiers

Extensive history of seizures

Ventilator dependence or patent tracheostomy site

History of neurologic disorder other than spinal cord injury (SCI)

History of moderate or severe head trauma

Trial design

Design model

Crossover

Treatments tested in this trial

  • Natesto testosterone intranasal gel

    Drug

    A single dose of Natesto (11 mg total, 5.5 mg per nostril) will be administered to each participant.

  • Ayr Saline Nasal Gel

    Drug

    A single dose of Ayr (one spray per nostril) will be administered to each participant.

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Intranasal TRTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Electromyographic (EMG) responses

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.

Time frame
up to one day

Secondary outcomes

1

Serum Testosterone

Serum testosterone will be assessed prior to and after administration of intranasal TRT.

Time frame
up to one day
2

Cardiovagal Function (heart rate variability)

Changes in beat-by-beat heart rate (beats per minute) signals collected using ECG during a cold face challenge (cardiovagal provocation) to determine cardiovagal reflex function. Changes in the high frequency (0.15-0.4 Hz) component will be used as an indication of parasympathetic activity to the heart.

Time frame
up to one day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
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