Sildenafil Treatment for Mild TBI

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Vascular System Injuries, Concussion, Brain, Post-Concussion Syndrome

In brief

About 300,000 people are hospitalized for traumatic brain injury (TBI) each year. After TBI, secondary brain injury escalates due in part to heightened levels of oxidant injury, inflammation, and vascular injury. Traumatic cerebral vascular injury (TCVI) may begin almost immediately after the primary injury and evolve into chronic neurodegenerative conditions. TCVI is a very complex TBI endophenotype and microvascular injuries have been described in a plethora of animal and human TBI studies. These injuries consist of endothelial injury, disruption of the blood brain barrier (BBB), a reduction of capillary density, intravascular microthrombi, and white-matter degeneration. Recently, use of magnetic resonance imaging (MRI)-Blood Oxygen Level Dependent (BOLD) combined with hypercapnia (high spatial and temporal resolution) by our research group has proven to be more sensitive at measuring alterations of cerebral blood flow (CBF) in TBI subjects. The goal of the proposed research is to test the efficacy of Viagra® (sildenafil) at normalizing CBF and improving cognitive outcomes in people that have experienced a TBI. Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor that has previously been administered as a therapy for high blood pressure and erectile dysfunction. In people that have been affected by stroke-induce neurotrauma, sildenafil improved CBF and was found to be neuroprotective. With respect to chronic TBI, previous studies have demonstrated that sildenafil therapy potentiates cardiovascular reactivity (CVR) in areas of the brain with damaged endothelium. In this proposal, the investigators will test the hypothesis that sildenafil treatment in boxers/Mixed Martial Arts (MMA) fighters soon after concussion normalizes CBF, potentiates CVR, reduces post-concussion symptoms, and improves cognition.

Key facts

Study ID: NCT03598140
Run by: University of Texas Southwestern Medical Center
People needed: 22
Starts: 2018-07-25
Expected to finish: 2019-05-29
Last updated by the study team: 2020-11-19

Who can join

Age: 18 and older, up to 35. Sex: male. Healthy volunteers: accepted.

You may qualify if…

For Athletes
Age 18-35
Male or female professional boxers/MMA fighters
Ability to undergo MR imaging procedures
At least one of the following:
Knockout (KO)/Technical Knockout (TKO) scored by fight referee.
Greater than 25 blows to the head.
Significant post-concussive symptoms (Symptom Score > 1 on at least 3 items from the Rivermead Post-Concussion Questionnaire)
For Controls
Age 18-35
Male of female who do not participate in contact sports
Screen negative for mild TBI (mTBI) using Ohio State TBI Identification

You may not qualify if…

Contraindication to sildenafil which includes the following:
Current use of organic nitrate vasodilators
Use of ritonavir (HIV-protease inhibitor)
Current use of erythromycin, ketoconazole, or itraconazole
Current use of cimetidine
Current resting hypotension (BP < 90/50 mm Hg)
Current severe renal insufficiency (Creatinine Clearance < 30 milliliters/minute)
Current hepatic cirrhosis
Current cardiac failure or coronary artery disease causing unstable angina
Retinitis pigmentosa
Known hypersensitivity or allergy to sildenafil of any of its components
Daily therapy with a PDE5 inhibitor within the past 2 months
Immediate hospitalization for severe concussion
History of neurological or psychiatric disorder not related to TBI
Known inclusion in another interventional clinical trial
Subjects with metal implants that would interfere with the MR imaging procedures
Sickle cell disease
History of priapism

Where it is running

University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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