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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1
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104