Sildenafil Treatment for Mild TBI
কীওয়ার্ডস
বিমূর্ত
বর্ণনা
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.
তারিখ
সর্বশেষ যাচাই করা হয়েছে: | 08/31/2019 |
প্রথম জমা দেওয়া: | 06/10/2018 |
আনুমানিক তালিকাভুক্তি জমা দেওয়া হয়েছে: | 07/12/2018 |
প্রথম পোস্ট: | 07/25/2018 |
সর্বশেষ আপডেট জমা দেওয়া হয়েছে: | 09/05/2019 |
সর্বশেষ আপডেট পোস্ট: | 09/09/2019 |
আসল অধ্যয়ন শুরুর তারিখ: | 07/24/2018 |
আনুমানিক প্রাথমিক সমাপ্তির তারিখ: | 06/29/2021 |
আনুমানিক অধ্যয়ন সমাপ্তির তারিখ: | 12/30/2021 |
অবস্থা বা রোগ
হস্তক্ষেপ / চিকিত্সা
Drug: Sildenafil Citrate
Drug: Placebo oral capsule
পর্যায়
বাহু গ্রুপ
বাহু | হস্তক্ষেপ / চিকিত্সা |
---|---|
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) |
যোগ্যতার মানদণ্ড
বয়স অধ্যয়নের জন্য যোগ্য | 18 Years প্রতি 18 Years |
লিঙ্গ অধ্যয়নের জন্য যোগ্য | Male |
স্বাস্থ্যকর স্বেচ্ছাসেবীদের গ্রহণ করে | হ্যাঁ |
নির্ণায়ক | 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 |
ফলাফল
প্রাথমিক ফলাফল ব্যবস্থা
1. Arterial Spin Labeling [3 years]
মাধ্যমিক ফলাফলের ব্যবস্থা
1. Rivermead Post Concussion Symptoms Questionnaire (RPQ) [3 years]
2. Hopkins Verbal Learning Task (HVLT) [3 years]
3. BOLD MRI with hypercapnia [3 years]