The Effect of Respiratory Challenge on the BOLD Signal
Part of paid clinical trials in St Louis, Missouri.
- Sponsor
- Washington University School of Medicine
- Study ID
- NCT04258774
- Status
- Enrolling By Invitation
Conditions
- Hypercapnia
- Hyperoxia
- Hypocapnia
- Hypoxia, Brain
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Carbon Dioxide — OTHERThe study team will administer inhaled carbon dioxide to the participants during an MRI at a level
Study Details
The purpose of this research study is to better understand how blood flow and metabolism are different between normal controls and patients with disease. The investigators will examine brain blood flow and metabolism using magnetic resonance imaging (MRI). The brain's blood vessels expand and constrict to regulate blood flow based on the brain's needs. The amount of expanding and contracting the blood vessels can do varies by age. The brain's blood flow changes in small ways during everyday activities, such as normal brain growth, exercise, or deep concentration. Significant illness or physiologic stress may increase the brain's metabolic demand or cause other bigger changes in blood flow. If blood vessels are not able to expand to give more blood flow when metabolic demand is high, the brain may not get all of the oxygen it needs. In less extreme circumstances, not having as much oxygen as it wants may cause the brain to grow and develop more slowly than it should. One way to test the ability of the blood vessels to expand is by measuring blood flow while breathing in carbon dioxide (CO2). CO2 causes blood vessels in the brain to dilate without increasing brain metabolism. The study team will use a special mask to control the amount of oxygen and carbon dioxide patients breath in so that we can study how their brain reacts to these changes. This device designed to simulate carbon dioxide levels achieved by a breath-hold and target the concentration of carbon dioxide in the blood in breathing patients. The device captures exhaled gas and provides an admixture of fresh gas and neutral/expired gas to target different carbon dioxide levels while maintaining a fixed oxygen level. The study team will obtain MRI images of the brain while the subjects are breathing air controlled by the device.
Key Dates
- Start date
- Jan 29, 2020
- Status verified
- Jan 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 48 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Active Comparator: Healthy Adults
- Active Comparator: Adults diagnosed with vascular pathology of the brain
Primary Outcome Measure
Cerebral Oxygen Metabolism [ Time Frame: From the beginning of the MRI scan to the completion of the MRI scan -- 75 minutes. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Washington University of St. Louis | St Louis | Missouri | 63110 | - |
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