Status:

TERMINATED

Cerebrovascular Reactivity in American Football Players

Lead Sponsor:

University of Pennsylvania

Collaborating Sponsors:

Boston University

Conditions:

Traumatic Brain Injury

Mild Traumatic Brain Injury

Eligibility:

MALE

40-65 years

Phase:

PHASE1

Brief 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 trau...

Eligibility Criteria

Inclusion

  • Age 40-65 years
  • Former National Football League (NFL) players or former varsity college football players
  • Ability to undergo MRI scanning
  • Ability to read, write, and speak English
  • Stable doses of concomitant medications for last 2 weeks prior to enrollment
  • Diagnosis of post-concussive syndrome according to Diagnostic and Statistical Manual 5 (DSM-5) criteria

Exclusion

  • Contraindication to sildenafil
  • Past medical history or evidence of penetrating brain injury
  • Daily therapy with a PDE5 inhibitor within the past 2 months, or taken as needed within past 4 weeks
  • History or evidence of pre-existing disabling neurological or psychiatric disorder not related to previous head injuries
  • History of melanoma
  • History of diagnosed obstructive/ restrictive pulmonary disease 7 .) Contraindication to MRI

Key Trial Info

Start Date :

March 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 30 2022

Estimated Enrollment :

7 Patients enrolled

Trial Details

Trial ID

NCT03417492

Start Date

March 1 2018

End Date

June 30 2022

Last Update

September 21 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States, 19104