NCT03417492

Cerebrovascular Reactivity in American Football Players

Cerebrovascular Reactivity Assessed With Functional Near-infrared Spectroscopy and Magnetic Resonance Imaging as a Biomarker of Traumatic Microvascular Injury in American Football Players

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Male
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury
• Mild Traumatic Brain Injury
• Post-Concussion Syndrome

Interventions

Type	Name	Description
DRUG	Sildenafil Citrate	Three 20 mg capsules for the single dose studies. For the 5-week treatment phase, subjects will be assigned to a titration of doses for the 5 week duration of the study. Subjects will be instructed to take 20mg twice per day for 3 days, then 40mg twice per day for 3 days, and then 80mg twice per day for 4 weeks.

Timeline

• Start date: 2018-03-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2018-01-31
• Last updated: 2022-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study