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NCT03417492 · ClinicalTrials.gov registry record · Phase 1

Cerebrovascular Reactivity in American Football Players

A Phase 1 study, sponsored by University of Pennsylvania.

Terminated
Registry status
Phase 1
Development phase
7
Enrollment target

NCT03417492: Clinical Trial Phase 1 study, sponsored by University of Pennsylvania.

NCT03417492 is a Phase 1 study that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03417492, a Phase 1 study, was terminated before completion, sponsored by University of Pennsylvania.

TERMINATED
Registry status
Phase 1
Development phase
7 participants
Enrollment target

Study Summary

Investigators will measure cerebrovascular reactivity (CVR) using functional near-infrared spectroscopy (fNIRS) and magnetic resonance imaging (MRI) during the chronic phase after repetitive mild traumatic brain injury (rmTBI) as a biomarker of traumatic cerebrovascular injury (TCVI). We hypothesize that CVR will be decreased in patients with rmTBI and that these decreases will correlate with clinical outcomes. Furthermore, we predict that 5 week administration of a phosphodiesterase 5 (PDE5) inhibitor, sildenafil citrate, will augment CVR in patients with a history rmTBI.

Primary Outcome

Determine if single dose treatment with sildenafil (60 mg orally) is effective in increasing the global BOLD response to hypercapnia (5% CO2).

Interventions

  • DRUG Sildenafil Citrate

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2018-03-01
Est. Completion 2022-06-30
Phase Phase 1
University of Pennsylvania

1,423 total trials

Why NCT03417492 stopped before completion

NCT03417492 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 1 intervention - of which Sildenafil Citrate is the first listed.

NCT03417492 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03417492 about?

NCT03417492 is a clinical study titled "Cerebrovascular Reactivity in American Football Players". Investigators will measure cerebrovascular reactivity (CVR) using functional near-infrared spectroscopy (fNIRS) and magnetic resonance imaging (MRI) during the chronic phase after repetitive mild traumatic brain injury (rmTBI) as a biomarker of traumatic cerebrovascular injury (TCVI). We hypothesize...

What is the current status of trial NCT03417492?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2018-03-01. Estimated completion is 2022-06-30.

What interventions are being tested in trial NCT03417492?

The interventions under investigation include: Sildenafil Citrate (DRUG).

Who is sponsoring clinical trial NCT03417492?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03417492's enrollment target sits among peer trials

7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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

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Source: ClinicalTrials.gov NCT03417492, the US trial registry maintained by the National Library of Medicine. NCT03417492 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.