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The Role of Oxygen Reserve in Brain Development

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04406818
Recruitment Status : Not yet recruiting
First Posted : May 28, 2020
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
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 change can influence brain development in the early decades of life. SCA participants and healthy controls are age and sex-matched for comparison. Within the SCA cohort, children with infarcts may have thinner cortices than those without, reflecting a greater loss.

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 psychological 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 extreme circumstances, if the brain is unable to get enough oxygen for a long time, a stroke may occur. Sometimes small strokes occur without other noticeable changes and are only detectable on an MRI. These are sometimes called "silent strokes." 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 blood vessels to expand is by measuring blood flow while breathing in carbon dioxide. Carbon dioxide causes blood vessels in the brain to dilate without increasing brain metabolism.

During this study participants may be asked to undergo a blood draw, MRI, and potential neuropsychological assessments. It is also possible that the study team will use a special mask to control the amount of carbon dioxide the participants breathe in so they don't breathe in too much.


Condition or disease Intervention/treatment Phase
Child, Only Brain Diseases Sickle Cell Disease Anemia, Sickle Cell Drug: Carbon Dioxide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Role of Oxygen Reserve in Brain Growth and Cortical Thickness in Children With and Without Sickle Cell Anemia
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : March 31, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Healthy Control Drug: Carbon Dioxide
Participants inhale carbon dioxide while in magnetic resonance imaging scan to measure cerebrovascular reactivity

Active Comparator: Sickle Cell Anemia Drug: Carbon Dioxide
Participants inhale carbon dioxide while in magnetic resonance imaging scan to measure cerebrovascular reactivity




Primary Outcome Measures :
  1. Gray Matter cortical thickness [ Time Frame: 3 years ]
    Mean whole brain cortical thickness on high resolution T1 images


Secondary Outcome Measures :
  1. Total Brain volume [ Time Frame: 3 years ]
    Total brain volume (gray matter and white matter) on high resolution T1 image



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Healthy Controls:

  • Healthy controls ages 4-21 years of age
  • Able to participate in MRI scan without sedation
  • Not currently pregnant
  • No significant psychiatric history, defined as having a severe psychiatric diagnosis, per PI discretion
  • No seizure history
  • No history of stroke or cerebrovascular disease
  • May have occasional headaches if not taking a daily preventative medication for headaches
  • Not on vasodilatory medication, such as sildenafil or verapamil

Sickle Cell Anemia Participants:

  • Ages 4-21 years of age
  • Hb SS or SBeta-thal
  • Able to participate in MRI scan without sedation
  • Not currently pregnant
  • Not on vasodilatory medication, such as sildenafil or verapamil
  • No known vasculopathy

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): NCT04406818


Contacts
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Contact: Madison Streb, BA 3142730828 m.streb@wustl.edu
Contact: Kristin Guilliams, MD 3144546120 kristinguilliams@wustl.edu

Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04406818    
Other Study ID Numbers: 771237
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Informed Consent Form (ICF)
Time Frame: At study conclusion
Access Criteria: Upon request by qualified researchers

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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:
sickle cell anemia
cerebrovascular reactivity
cerebral oxygen metabolism
cortical thickness
gray matter
carbon dioxide
magnetic resonance imaging
brain development
Additional relevant MeSH terms:
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Brain Diseases
Anemia
Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Central Nervous System Diseases
Nervous System Diseases