Neurodegenerative DiseasesNCT04820881
Cerebrovascular Reactivity and Oxygen Metabolism as Markers of Neurodegeneration After Traumatic Brain Injury
An observational study of Neurodegenerative Diseases, run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Diseases
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Middle-aged and older adults with previous head injury experiencing current neurodegeneration.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Washington, DC Veterans Affairs Medical Center
Washington D.C., District of Columbia, 20422
Julie C Chapman, PsyD, 202-745-8000 ext. 55024, Julie.Chapman@va.gov
Marshall S Balish, MD, PhD, 202.745.8148, Marshall.Balish@va.gov
About this study
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.
Read the 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 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.
- Conditions
- Neurodegenerative Diseases
- Medical subject headings
- Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Oct 2021
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington D.C. Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Responsible party
- Principal investigator, Julie C. Chapman, Washington D.C. Veterans Affairs Medical Center
- Investigators
- Julie C Chapman, PsyD, Principal investigator, Washington, DC VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820881
- Sponsor's protocol ID
- MIRB01897
- Status last verified
- Apr 2022
- First submitted
- 24 Mar 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The grant that funds this study requires that de-identified data be submitted annually to the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System, of which the Department of Veterans Affairs is part. The FITBIR database, maintained by the National Institutes of Health, allows other researchers studying traumatic brain injury to apply for approval to utilize this previously collected, de-identified data for qualified research projects. Only de-identified data, which does not include anything that might directly identify participants, will be shared with FITBIR users who have been approved for research use.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrovascular Reactivity and Oxygen Metabolism as Markers of Neurodegeneration After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04820881
- Acronym / sponsor ID
- MIRB01897
- Conditions
- Neurodegenerative Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Washington D.C. Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Middle-aged and older adults with previous head injury experiencing current neurodegeneration.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: Yes. The grant that funds this study requires that de-identified data be submitted annually to the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System, of which the Department of Veterans Affairs is part. The FITBIR database, maintained by the National Institutes of Health, allows other researchers studying traumatic brain injury to apply for approval to utilize this previously collected, de-identified data for qualified research projects. Only de-identified data, which does not include anything that might directly identify participants, will be shared with FITBIR users who have been approved for research use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie C Chapman, PsyD principal investigator
Washington, DC VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodegenerative Diseases, run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie C Chapman, PsyD (202-745-8000 ext. 55024, Julie.Chapman@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebrovascular Reactivity (CVR) (time frame: Two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.