Sildenafil Treatment for Mild TBI
Keywords
Abstract
Description
In this study, 100 professional boxers that experience a concussion will be enrolled, randomized to either placebo or sildenafil (60mg) drug treatment, and arterial spin labeling and BOLD-MRI with hypercapnia will used to assess CBF and CVR, respectively. Symptom reporting, blood biomarkers, and neuropsychological testing will also be conducted. The timepoints for this study are baseline (pre-fight), and once between days 1 and 3 and day 30 after injury.
Dates
| Last Verified: | 08/31/2019 |
| First Submitted: | 06/10/2018 |
| Estimated Enrollment Submitted: | 07/12/2018 |
| First Posted: | 07/25/2018 |
| Last Update Submitted: | 09/05/2019 |
| Last Update Posted: | 09/09/2019 |
| Actual Study Start Date: | 07/24/2018 |
| Estimated Primary Completion Date: | 06/29/2021 |
| Estimated Study Completion Date: | 12/30/2021 |
Condition or disease
Intervention/treatment
Drug: Sildenafil Citrate
Drug: Placebo oral capsule
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: Placebo oral capsule If randomized to placebo, the participant will receive single (Group 1) or multiple (once-a-day for 14 days; Group 2) treatments. | Drug: Placebo oral capsule Placebo once (Group 1) or daily for 2 weeks (Group 2) |
| Active Comparator: Sildenafil Citrate If randomized to sildenafil (60mg), the participant will receive single (Group 1) or multiple (once-a-day for 14 days; Group 2) treatments. | Drug: Sildenafil Citrate Sildenafil 60mg once (Group 1) or daily for 2 weeks (Group 2) |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Male |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: For Athletes 1. Age 18-35 2. Male or female professional boxers/MMA fighters 3. Ability to undergo MR imaging procedures 4. At least one of the following: 1. Knockout (KO)/Technical Knockout (TKO) scored by fight referee. 2. Greater than 25 blows to the head. 5. Significant post-concussive symptoms (Symptom Score > 1 on at least 3 items from the Rivermead Post-Concussion Questionnaire) For Controls 1. Age 18-35 2. Male of female who do not participate in contact sports 3. Screen negative for mild TBI (mTBI) using Ohio State TBI Identification Exclusion Criteria: 1. Contraindication to sildenafil which includes the following: 1. Current use of organic nitrate vasodilators 2. Use of ritonavir (HIV-protease inhibitor) 3. Current use of erythromycin, ketoconazole, or itraconazole 4. Current use of cimetidine 5. Current resting hypotension (BP < 90/50 mm Hg) 6. Current severe renal insufficiency (Creatinine Clearance < 30 milliliters/minute) 7. Current hepatic cirrhosis 8. Current cardiac failure or coronary artery disease causing unstable angina 9. Retinitis pigmentosa 10. Known hypersensitivity or allergy to sildenafil of any of its components 2. Daily therapy with a PDE5 inhibitor within the past 2 months 3. Immediate hospitalization for severe concussion 4. History of neurological or psychiatric disorder not related to TBI 5. Known inclusion in another interventional clinical trial 6. Subjects with metal implants that would interfere with the MR imaging procedures 7. Sickle cell disease 8. History of priapism |
Outcome
Primary Outcome Measures
1. Arterial Spin Labeling [3 years]
Secondary Outcome Measures
1. Rivermead Post Concussion Symptoms Questionnaire (RPQ) [3 years]
2. Hopkins Verbal Learning Task (HVLT) [3 years]
3. BOLD MRI with hypercapnia [3 years]
