Cerebrovascular Reactivity and Oxygen Metabolism as Markers of Neurodegeneration After Traumatic Brain Injury
NCT ID: NCT04820881
Last Updated: 2022-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2021-10-01
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case Group
Measurement of cerebrovascular reactivity and oxygen metabolism before and after a single dose of 50mg sildenafil citrate. Diffusion tensor imaging, other structural imaging and cognitive testing will also be completed.
No interventions assigned to this group
Control Group
Measurement of cerebrovascular reactivity and oxygen metabolism before and after a single dose of 50mg sildenafil citrate. Diffusion tensor imaging, other structural imaging and cognitive testing will also be completed.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Eligible for Washington, DC Veterans Affairs Medical Center (VAMC) research participation
* Capacity to provide consent to participate in research (assessment made by study neurologist and PI)
* Ability to read and write English
• History of traumatic brain injury of sufficient severity to have resulted in medical attention ascertained via the Ohio State University TBI Identification Questionnaire (OSU TBI-ID). TBI defined by Departments of Defense/Veterans Affairs (DoD/VA) criteria.
• No history of traumatic brain injury of sufficient severity to have resulted in medical attention ascertained via the OSU TBI-ID, and no TBI based upon DOD/VA criteria.
Exclusion Criteria
* History or evidence of disabling neurological or psychiatric condition such as epilepsy (besides posttraumatic epilepsy), multiple sclerosis, hypoxic-ischemic encephalopathy, encephalitis, or schizophrenia
* History or evidence of cortical or subcortical stroke
* History or evidence of diabetes mellitus requiring therapy (Hemoglobin A1c \> 9.0% for purposes of this study)
* History or evidence of uncontrolled hyperlipidemia. For the purposes of this study, "hyperlipidemia" will be defined as total cholesterol of 230 in the presence of either or both diabetes and hypertension and 300 in the absence of both of these conditions.
Statin therapy with normal cholesterol levels is allowed.
* History or evidence of uncontrolled hypertension (defined as systolic pressure \> 160 and/or diastolic pressure \> 110 mmHg), or hypotension (systolic pressure \< 110 and/or diastolic pressure \< 65 mmHg). Hypertension controlled with a single anti- hypertensive medication is allowed.
* Untreated atrial fibrillation
* Active tobacco use
* MRI incompatibility
* If a participant is currently or has previously taken a phosphodiesterase inhibitor (PDESi), then a two week washout period is required immediately prior to the evaluation visit.
* Use of nitrates
50 Years
80 Years
ALL
Yes
Sponsors
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Henry M. Jackson Foundation for the Advancement of Military Medicine
OTHER
Washington D.C. Veterans Affairs Medical Center
FED
Responsible Party
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Julie C. Chapman
Neuroscientist
Principal Investigators
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Julie C Chapman, PsyD
Role: PRINCIPAL_INVESTIGATOR
Washington, DC VAMC
Locations
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Washington, DC Veterans Affairs Medical Center
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MIRB01897
Identifier Type: -
Identifier Source: org_study_id
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