Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06130449 · ClinicalTrials.gov registry record · Early Phase 1
Testosterone and Neural Function
A Early Phase 1 study of Spinal Cord Injury, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT06130449: Recruiting Early Phase 1 study of Spinal Cord Injury, sponsored by VA Office of Research and Development.
NCT06130449 is a Early Phase 1 study of Spinal Cord Injury that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 15 participants, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06130449, a Early Phase 1 study of Spinal Cord Injury, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Natesto testosterone intranasal gel
- DRUG Ayr Saline Nasal Gel
Study Locations (1)
New York
- James J. Peters VA Medical Center, Bronx, NY - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2026-09-30 |
| Phase | Early Phase 1 |
What NCT06130449 shows while recruiting
NCT06130449 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Spinal Cord Injury appearing as the primary indexed condition, and to 2 interventions - of which Natesto testosterone intranasal gel is the first listed.
NCT06130449 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06130449 about?
NCT06130449 is a clinical study titled "Testosterone and Neural Function". 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 impa...
What is the current status of trial NCT06130449?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2024-04-01. Estimated completion is 2026-09-30.
What conditions does trial NCT06130449 study?
This clinical trial studies the following conditions: Spinal Cord Injury.
What interventions are being tested in trial NCT06130449?
The interventions under investigation include: Natesto testosterone intranasal gel (DRUG), Ayr Saline Nasal Gel (DRUG).
Who is sponsoring clinical trial NCT06130449?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06130449 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06130449's enrollment target sits among peer trials
15 68th of 99 higher than 28 of 99 other Spinal Cord Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury
RECRUITING · Early Phase 1
-
MEP Up-conditioning to Target Corticospinal Plasticity
RECRUITING · Early Phase 1
-
Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis
RECRUITING · Early Phase 1
-
Cortical Recording and Stimulating Array Brain-Machine Interface
RECRUITING · NA
-
Clinical Outcome Assessment for AT & BCI
RECRUITING · NA
-
Motoneuron Recruitment and Motor Evoked Potential Up-Conditioning (MEP) in Spinal Cord Injury (SCI)
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01889381 · 15 participants · Phase 2
Human Craniomaxillofacial Allotransplantation
- NCT02530073 · 15 participants · NA
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
- NCT02535936 · 15 participants · NA
Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
- NCT02918474 · 15 participants · NA
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI