Metabolic and Hemodynamic Reserve in Pediatric SCA

Not Applicable

Recruiting

• Conditions: Sickle Cell Disease; Anemia, Sickle Cell; Child, Only; Brain Diseases
• Interventions: Drug: Carbon Dioxide

• Registration Number: NCT04406818
• Lead Sponsor: 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-05-28
• Study Start: 2021-06-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sickle Cell Anemia	Carbon Dioxide	-
Healthy Control	Carbon Dioxide	-

Primary Outcome Measures

Name	Time	Method
Gray Matter cortical thickness	3 years	Mean whole brain cortical thickness on high resolution T1 images

Secondary Outcome Measures

Name	Time	Method
Total Brain volume	3 years	Total brain volume (gray matter and white matter) on high resolution T1 image
Cerebrovascular Reactivity	15 minutes	Change in blood flow as measured by MRI in response to carbon dioxide

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States