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

NCT04820881 | Unknown

• 1 other identifier: MIRB01897
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (2)

• Cerebrovascular Reactivity (CVR)

  Cerebrovascular reactivity is the change in cerebral blood flow in response to a vasoactive stimulus, in this case hypercapnia induced by 5% carbon dioxide as measured by MRI BOLD

  Two years

• Cerebral Metabolic Rate of Oxygen (CMRO2)

  Cerebral metabolic rate of oxygen represents the amount of oxygen consumed as measured by the MRI T2-Relaxation-Under-Spin-Tagging (TRUST) sequence.

  Two years

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Middle-aged and older adults with previous head injury experiencing current neurodegeneration.

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington D.C. Veterans Affairs Medical Center: lead
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator

Study Sites (1)

Washington, DC Veterans Affairs Medical Center

Washington D.C., District of Columbia, 20422, United States

RECRUITING

MeSH Terms

Conditions

Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Julie C Chapman, PsyD

  Washington, DC VAMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie C Chapman, PsyD

CONTACT

202-745-8000; Julie.Chapman@va.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neuroscientist

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 29, 2021
• Study Start: October 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Time frame specified by the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics Program.
• Access Criteria: Access criteria specified by the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics Program.

Locations

US (1)