Is NCT05782244 recruiting in Philadelphia, PA?

Yes, NCT05782244 is currently recruiting participants at its Philadelphia, PA location. This traumatic brain injury clinical trial is actively enrolling qualified participants.

How do I join the traumatic brain injury clinical trial in Philadelphia?

To join this clinical trial in Philadelphia, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Philadelphia clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Traumatic Brain Injury Clinical Trial in Philadelphia, PA

About This Traumatic Brain Injury Study in Philadelphia

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 sildenafil 50 mg potentiates CVR in areas of the brain with dysfunctional endothelium, and that CVR is a reliable diagnostic marker of TCVI and has potential as a pharmacodynamic and predictive biomarker. In this proposal, the investigators will conduct a randomized clinical trial to determine the optimal PDE5 inhibitor dose to improve or normalize microvascular function (as measured by the change in CVR measurements before and after a single dose of sildenafil, or ΔCVR) using a range of sildenafil citrate doses: 20, 40, 80 mg) in chronic TBI patients. The investigators will also test the safety and tolerability of the same dose ranges of chronic (4-week) thrice daily sildenafil or placebo administration in chronic TBI patients and explore its effects on chronic symptoms and clinical outcomes.

Sponsor: University of Pennsylvania

Who Can Participate

Inclusion Criteria

To be eligible to participate in this study, an individual must meet all of the following criteria:

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Male or female, aged 18-70

Defense Enrollment Eligibility Reporting System (DEERS) eligible (WRNMMC only; N/A for UPenn)

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;

Plausible Mechanism of Injury: Criterion 1 focuses on the external force that likely disrupted brain function, including blast/explosion forces and acknowledging intentional causes.

Clinical Signs: Criterion 2 highlights signs observed or elicited during examination, distinguishing them from subjective symptoms.

Acute Symptoms: Criterion 3 considers subjective acute symptoms, requiring at least two symptoms to be present.

Clinical Examination/Laboratory Findings: Criterion 4 is a new addition, incorporating findings like cognitive impairment or oculomotor impairment.

Neuroimaging: While not required for diagnosis, neuroimaging can be used to provide further evidence of brain injury.

Chronic persistent post-concussive symptoms (Symptom Score \> 1 on at least 3 items from the Rivermead Post-Concussion Symptom Questionnaire; RPQ)

Glasgow Outcome Scale-Extended (GOSE) between 5-7

Ability to take oral medication and be willing to adhere to the study intervention regimen

Ability to participate in and complete 1 MRI including 2 CVR challenges and 4-week treatment period.

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:

Contraindication to sildenafil which includes the following:

Current/ongoing (within past month) use of organic nitrate vasodilators or riociguat

Current/ongoing (within past month) use of ritonavir (HIV-protease inhibitor)

Current/ongoing (within past month) use of erythromycin, ketoconazole, or itraconazole

Current/ongoing (within past month) use of cimetidine

Current resting hypotension (BP \< 90/50 mm Hg)

Current severe renal insufficiency

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

History of melanoma or suspicious skin lesions for melanoma on skin examination

Daily therapy with a PDE5 inhibitor within the month prior to consent

History of penetrating TBI

History of disabling neurological or psychiatric disorder not related to TBI

Active substance abuse or dependence during the past 6 months

Estimated preinjury intellectual level ≤70 (based on educational and vocational history)

Inability to understand written and spoken English, in the opinion of the investigator

Current inclusion in another interventional trial

Subjects with metal implants that would interfere with the MR imaging procedures

History of priapism

Pregnant or breast-feeding women

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)

Hypertension requiring treatment with more than two antihypertensive drugs

Hyperlipidemia requiring treatment with more than one lipid lowering drug

Diabetes mellitus requiring medical treatment with insulin

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Philadelphia?

Yes, this clinical trial (NCT05782244) has an active research site in Philadelphia, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Traumatic Brain Injury Treatment Options in Philadelphia, PA

If you're searching for traumatic brain injury treatment options in Philadelphia, PA, this clinical trial (NCT05782244) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Philadelphia research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced traumatic brain injury specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all traumatic brain injury clinical trials near you to find additional studies recruiting in your area.

Traumatic Brain Injury Clinical Trial in Philadelphia, PA

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