๐ฌIn plain words
What the trial is, and whether it could suit you
Traumatic Cerebral Vascular Injury (TCVI) is a common consequence of traumatic brain injury (TBI), including mild TBI (mTBI). TCVI is associated with poor recovery after TBI in animal models. TCVI can be measured non-invasively in humans, and therapies targeting TCVI are attractive candidates to ameliorate the consequences of TBI. Sildenafil potentiates nitric oxide (NO) dependent vasodilatation and is approved by the Food and Drug Administration (FDA) for the treatment of erectile dysfunction and primary pulmonary hypertension. In pre-clinical models of stroke, sildenafil improves cerebral blood flow (CBF), promotes, angiogenesis, neurogenesis and improves recovery. In an initial Phase 2a trial (NCT01762475) of sildenafil in patients with chronic moderate to severe TBI, the investigators found that low dose sildenafil (25 mg BID) therapy is safe and well tolerated, that a single dose of
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria
To be eligible to participate in this study, an individual must meet all of the following criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18-70
4. Defense Enrollment Eligibility Reporting System (DEERS) eligible (WRNMMC only; N/A for UPenn)
5. History of TBI greater than 6 months and less than 25 years prior to enrollment, based on the 2023 American Congress of Rehabilitation Medicine Criteria92;
1. Plausible Mechanism of Injury: Criterion 1 focuses on the external force that likely disrupted brain function, including blast/explosion forces and acknowledging intentional causes.
2. Clinical Signs: Criterion 2 highlights signs observed or elicited during examination, distinguishing them from subjective symptoms.
3. Acute Symptoms: Criterion 3 considers subjective acute symptoms, requiring at least two symptoms to be present.
4. Clinical Examination/Laboratory Findings: Criterion 4 is a new addition, incorporating findings like cognitive impairment or oculomotor impairment.
5. Neuroimaging: While not required for diagnosis, neuroimaging can be used to provide further evidence of brain injury.
6. Chronic persistent post-concussive symptoms (Symptom Score \> 1 on at least 3 items from the Rivermead Post-Concussion Symptom Questionnaire; RPQ)
7. Glasgow Outcome Scale-Extended (GOSE) between 5-7
8. Ability to take oral medication and be willing to adhere to the study intervention regimen
9. Ability to participate in and complete 1 MRI including 2 CVR challenges and 4-week treatment period.
10. Adequate hearing and vision based on self-report and examiner's observation
Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Contraindication to sildenafil which includes the following:
1. Current/ongoing (within past month) use of organic nitrate vasodilators or riociguat
2. Current/ongoing (within past month) use of ritonavir (HIV-protease inhibitor)
3. Current/ongoing (within past month) use of erythromycin, ketoconazole, or itraconazole
4. Current/ongoing (within past month) use of cimetidine
5. Current resting hypotension (BP \< 90/50 mm Hg)
6. Current severe renal insufficiency
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
11. History of melanoma or suspicious skin lesions for melanoma on skin examination
2. Daily therapy with a PDE5 inhibitor within the month prior to consent
3. History of penetrating TBI
4. History of disabling neurological or psychiatric disorder not related to TBI
5. Active substance abuse or dependence during the past 6 months
6. Estimated preinjury intellectual level โค70 (based on educational and vocational history)
7. Inability to understand written and spoken English, in the opinion of the investigator
8. Current inclusion in another interventional trial
9. Subjects with metal implants that would interfere with the MR imaging procedures
10. History of priapism
11. Pregnant or breast-feeding women
12. Actively suicidal (based on clinician assessment OR if patient endorses item 9 on Patient Health Questionnaire 9 (PHQ-9) and endorses suicidal ideation on Columbia Suicide Severity Rating Scale(CSSRS)
13. Hypertension requiring treatment with more than two antihypertensive drugs
14. Hyperlipidemia requiring treatment with more than one lipid lowering drug
15. Diabetes mellitus requiring medical treatment with insulin