Status:
UNKNOWN
Cerebrovascular Reactivity and Oxygen Metabolism as Markers of Neurodegeneration After Traumatic Brain Injury
Lead Sponsor:
Washington D.C. Veterans Affairs Medical Center
Collaborating Sponsors:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Conditions:
Neurodegenerative Diseases
Eligibility:
All Genders
50-80 years
Brief Summary
This grant award entitled, "Cerebrovascular Reactivity and Oxygen Metabolism as Markers for Neurodegeneration after Traumatic Brain Injury" (hereafter, "Neurovascular Study"), aims to determine if neu...
Detailed Description
This grant award entitled, "Cerebrovascular Reactivity and Oxygen Metabolism as Markers for Neurodegeneration after Traumatic Brain Injury" (hereafter, "Neurovascular Study"), aims to determine if neu...
Eligibility Criteria
Inclusion
- Inclusion Criteria (All Participants):
- Ages 50-80 years
- 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
- Inclusion Criteria Case Group:
- • 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.
- Inclusion Criteria Control Group:
- • 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 (All Participants):
- History of penetrating brain injury
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04820881
Start Date
October 1 2021
End Date
September 1 2024
Last Update
April 27 2022
Active Locations (1)
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1
Washington, DC Veterans Affairs Medical Center
Washington D.C., District of Columbia, United States, 20422