- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04820881
Cerebrovascular Reactivity and Oxygen Metabolism as Markers of Neurodegeneration After Traumatic Brain Injury
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Julie C Chapman, PsyD
- Phone Number: 55024 202-745-8000
- Email: Julie.Chapman@va.gov
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20422
- Recruiting
- Washington, DC Veterans Affairs Medical Center
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Contact:
- Julie C Chapman, PsyD
- Phone Number: 55024 202-745-8000
- Email: Julie.Chapman@va.gov
-
Contact:
- Marshall S Balish, MD, PhD
- Phone Number: 202.745.8148
- Email: Marshall.Balish@va.gov
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebrovascular Reactivity (CVR)
Time Frame: Two years
|
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)
Time Frame: Two years
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Julie C Chapman, PsyD, Washington, DC VAMC
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIRB01897
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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