Status:
TERMINATED
Cerebrovascular Reactivity Assessed With fNIRS as a Biomarker of TCVI After Acute Traumatic Brain Injury in Military
Lead Sponsor:
Uniformed Services University of the Health Sciences
Collaborating Sponsors:
Walter Reed National Military Medical Center
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The study includes people who have recently had a traumatic brain injury (TBI) and healthy controls who have not had a TBI and is designed to measure brain blood flow serially after a TBI. Studies hav...
Detailed Description
Background and significance: Currently, more that 5.3 million Americans (or 2% of the population) live with disabilities resulting from TBI. Among OEF/OIF Veterans, TBI incidence estimates as high as...
Eligibility Criteria
Inclusion
- Inclusion Criteria (See Table 2 for more details)
- Age 18 to 55 years, inclusive
- Either gender
- TBI subjects ONLY: Meets DoD criteria for moderate or severe TBI and TBI occurred less than 30 days prior to study enrollment (Sustained a traumatically induced physiological disruption of brain function, as manifested by at least one of the following:
- . Period of loss of consciousness \> 30 minutes
- . Loss of memory for events lasting\> 24 hours after the accident
- . Alteration of mental state lasting\> 24 hours after the accident (e.g., feeling dazed, disoriented, and confused)
- . Clinical neuroimaging intracranial abnormality.
- Traumatically induced includes the head being struck, the head striking an object, or the brain undergoing an acceleration/deceleration movement (i.e. whiplash) without direct external trauma to the head.
- Ability to undergo fNIRS testing with hypercapnia challenge serially
- Ability to provide informed consent.
- Exclusion Criteria:
- Unstable respiratory or hemodynamic status
- Evidence of penetrating brain injury
- TBI requiring craniotomy or craniectomy
- History of disabling pre-existing neurologic disorder, e.g. dementia, uncontrolled epilepsy, multiple sclerosis, strokes, brain tumors, prior severe TBI, or other disorder that confounds interpretation of NIRS testing or neuropsychological results
- History of pre-existing disabling mental illness, e.g. major depression or schizophrenia
- Exclusion criteria for sildenafil:
- History of melanoma; Current use of organic nitrate vasodilators; Use of ritonavir (HIV-protease inhibitor); Current use of erythromycin, ketoconazole, or itraconazole; Current use of cimetidine; Current use of Alpha-blockers such as doxazosin (Cardura), tamsulosin (Flomax), and terazosin (Hytrin) prazosin (Minipress); Resting hypotension (systolic BP \<90); Severe renal insufficiency; Hepatic cirrhosis; Cardiac failure or coronary artery disease causing unstable angina; Retinitis pigmentosa; Pregnant or breastfeeding female; Known hypersensitivity or allergy to sildenafil.
- Inability to read and communicate in English
- Exclusion criterion for healthy subjects only: History of TBI.
- Current use of a PDE5 inhibitor (a drug such as Sildenafil, Tadalafil, Vardenafil, Avanafil, Udenafil,Dipyridamole, Vardenafil hydrochloride)
Exclusion
Key Trial Info
Start Date :
August 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04058132
Start Date
August 9 2019
End Date
March 1 2020
Last Update
February 28 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889