Cerebrovascular Reactivity in American Football Players

NCT ID: NCT03417492

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2022-06-30

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sildenafil Citrate

Open label treatment with forced titration of sildenafil citrate.

Group Type: EXPERIMENTAL

Sildenafil Citrate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Open label forced titration with sildenafil citrate.

Eligibility Criteria

Inclusion Criteria

1. Age 40-65 years

2. Former National Football League (NFL) players or former varsity college football players

3. Ability to undergo MRI scanning

4. Ability to read, write, and speak English

5. Stable doses of concomitant medications for last 2 weeks prior to enrollment

6. Diagnosis of post-concussive syndrome according to Diagnostic and Statistical Manual 5 (DSM-5) criteria

Exclusion Criteria

1. Contraindication to sildenafil

2. Past medical history or evidence of penetrating brain injury

3. Daily therapy with a PDE5 inhibitor within the past 2 months, or taken as needed within past 4 weeks

4. History or evidence of pre-existing disabling neurological or psychiatric disorder not related to previous head injuries

5. History of melanoma

6. History of diagnosed obstructive/ restrictive pulmonary disease 7 .) Contraindication to MRI

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Ramon Diaz-Arrastia

Presidential Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

827103

Identifier Type: -

Identifier Source: org_study_id