Testosterone and Neural Function

NCT06130449 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: B5028-M1IK1RX005028-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury

Keywords

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

Outcome Measures

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.

  up to one day

Secondary Outcomes (2)

• Serum Testosterone

  up to one day

• Cardiovagal Function (heart rate variability)

  up to one day

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participant-blinded (Ayr Saline Gel)

Drug: Ayr Saline Nasal Gel

Intranasal TRT

ACTIVE COMPARATOR

Participant-blinded (11 mg of Natesto)

Drug: Natesto testosterone intranasal gel

Interventions

Ayr Saline Nasal Gel DRUG

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

Also known as: Saline Nasal Gel

Placebo

Natesto testosterone intranasal gel DRUG

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

Also known as: testosterone intranasal gel

Intranasal TRT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jacob A Goldsmith, PhD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participant-blinded crossover placebo-controlled pilot study.

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 14, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)