NCT04406818 Metabolic and Hemodynamic Reserve in Pediatric SCA
| NCT ID | NCT04406818 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Child, Only |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-06-30 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2021-06-30 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Kristin P Guilliams, MD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT04406818 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 21 Years, studying Child, Only. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04406818 currently recruiting?
Yes, NCT04406818 is actively recruiting participants. Contact the research team at kristinguilliams@wustl.edu for enrollment information.
Where is the NCT04406818 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT04406818 clinical trial?
NCT04406818 is sponsored by Washington University School of Medicine. The principal investigator is Kristin P Guilliams, MD at Washington University School of Medicine. The trial plans to enroll 120 participants.