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The Effect of Respiratory Challenge on the BOLD Signal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04258774
Recruitment Status : Suspended (Temporarily halted due to COVID-19)
First Posted : February 6, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hypoxia, Brain Hyperoxia Hypercapnia Hypocapnia Other: Carbon Dioxide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All arms will receive the same study conditions.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Respiratory Challenge on the BOLD Signal
Actual Study Start Date : January 29, 2020
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Healthy Adults Other: Carbon Dioxide
The study team will administer inhaled carbon dioxide to the participants during an MRI at a level

Active Comparator: Adults diagnosed with vascular pathology of the brain Other: Carbon Dioxide
The study team will administer inhaled carbon dioxide to the participants during an MRI at a level




Primary Outcome Measures :
  1. Cerebral Oxygen Metabolism [ Time Frame: From the beginning of the MRI scan to the completion of the MRI scan -- 75 minutes. ]

Secondary Outcome Measures :
  1. Cerebrovascular Reactivity [ Time Frame: From administration of carbon dioxide to end of inhalation of carbon dioxide -- 15 minutes. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult subjects (>18 years old) OR adult patients (>18 years old) diagnosed with vascular pathology of the brain willing to participate and sign a consent form.
  2. Able to participate in MRI scan without sedation
  3. Not on stimulant medications
  4. No psychiatric history, as defined by seeing a psychiatrist for medical evaluation and treatment, or taking anti-depressant medications
  5. No seizure history
  6. May have occasional headaches if not taking a daily preventative medication for headaches
  7. Not on vasodilatory medication, such as sildenafil or verapamil

Exclusion Criteria:

  1. Subjects refusing to undergo testing
  2. Subjects with obstructive or resistive lung disease whose PaCO2 at rest is greater than 50mmHg or whose venous serum bicarbonate is greater than 26 mEq/L
  3. Subjects with pre-existing respiratory or metabolic acidosis
  4. Subjects who require portable oxygen at rest or with exercise
  5. Subjects with chronic heart failure or severe pulmonary disease who are unable to climb one flight of stairs due to shortness of breath
  6. Subjects with severe heart failure or restrictive lung disease with resting respiratory rate over 15 breaths/min 2. Patients that cannot participate in a course of rehabilitation therapy.
  7. Subjects that cannot undergo an MRI scan due to one of the following indications:

    • Pregnancy
    • Obtundation, or Coma
    • Confusion, Delirium, or Dementia
    • Unable to understand or carry out commands regarding keeping still and breathing pattern
    • Increased intracranial pressure due to space occupying lesion or obstruction of outflow of CSF
    • Claustrophobia
    • History of kidney problems
    • Pace makers
    • Skin tattoos
    • Neurostimulators (TENS-unit)
    • Implanted drug infusion device (i.e., insulin pump)
    • Exposure of metal fragments to your eye
    • Artificial heart valves
    • Aneurysm clips
    • Cochlear implants
    • Metallic implants and prosthesis
    • Vascular stent or stent graft
    • History as a metal worker
    • Shrapnel or bullet wounds
    • Dorsal column stimulators

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04258774


Locations
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United States, Missouri
Washington University of St. Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04258774    
Other Study ID Numbers: 201910105
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
brain metabolism
oxygen extraction fraction
cerebral vascular reactivity
carbon dioxide
Additional relevant MeSH terms:
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Hypoxia, Brain
Hypoxia
Hypercapnia
Hyperoxia
Hypocapnia
Signs and Symptoms, Respiratory
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases