Cerebrovascular Reactivity and Oxygen Metabolism as Markers of Neurodegeneration After Traumatic Brain Injury

  • STATUS
    Recruiting
  • End date
    Sep 10, 2024
  • participants needed
    60
  • sponsor
    Washington D.C. Veterans Affairs Medical Center
Updated on 10 May 2022
Accepts healthy volunteers

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 neurovascular contributors to neurodegeneration can serve as markers of the emergence or progression of degenerative processes after traumatic brain injury in middle-aged and older adults.

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 neurovascular contributors to neurodegeneration can serve as markers of the emergence or progression of degenerative processes after traumatic brain injury in middle-aged and older adults. Primary outcomes are cerebrovascular reactivity (CVR), as measured by functional Magnetic Resonance Imaging (MRI) Blood Oxygen Level Dependent (BOLD) and cerebral metabolic rate of oxygen (CMRO2) as assessed by the novel MRI sequence called, "T-2 Relaxation-Under-Spin-Tagging" (TRUST). After the baseline primary endpoints are acquired, a single dose of sildenafil 50mg will be given to assess for the effects of a hypercapnia task on CVR and CMRO2. Other outcomes measured include additional imaging sequences (diffusion, ASL), volumetric analysis, and neuropsychological tests.

Details
Condition Neurodegenerative Diseases
Clinical Study IdentifierNCT04820881
SponsorWashington D.C. Veterans Affairs Medical Center
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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
Clear my responses

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