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Metabolic and Hemodynamic Reserve in Pediatric SCA

The Role of Metabolic and Hemodynamic Reserve in Age-Related Brain Vulnerability in Pediatric Sickle Cell Anemia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04406818
Enrollment
120
Registered
2020-05-28
Start date
2021-06-30
Completion date
2027-03-31
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Sickle Cell, Brain Diseases, Child, Only, Sickle Cell Disease

Keywords

sickle cell anemia, cerebrovascular reactivity, cerebral oxygen metabolism, cortical thickness, gray matter, carbon dioxide, magnetic resonance imaging, brain development

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 may vary by age. The brain's blood flow changes in small ways during everyday activities, such exercise, deep concentration, or normal brain growth. 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 a full oxygen supply may cause the brain to grow and develop more slowly than when it has a full supply. 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, cognitive assessments, and brief questionnaires. The study team will use a special mask to control the amount of carbon dioxide the participants breathe in.

Interventions

DRUGCarbon Dioxide

Participants inhale carbon dioxide while in magnetic resonance imaging scan to measure cerebrovascular reactivity

Sponsors

Washington University School of Medicine
Lead SponsorOTHER
National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 21 Years
Healthy volunteers
Yes

Inclusion 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 history of epilepsy * 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

Design outcomes

Primary

MeasureTime frameDescription
Gray Matter cortical thickness3 yearsMean whole brain cortical thickness on high resolution T1 images

Secondary

MeasureTime frameDescription
Total Brain volume3 yearsTotal brain volume (gray matter and white matter) on high resolution T1 image
Cerebrovascular Reactivity15 minutesChange in blood flow as measured by MRI in response to carbon dioxide

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKristin P Guilliams, MD

Washington University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026