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Recruiting NCT04406818

Metabolic and Hemodynamic Reserve in Pediatric SCA

No phase Interventional Child, Only Brain Diseases Sickle Cell Disease Anemia, Sickle Cell

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Carbon Dioxide.
Who it may be relevant to
Registry conditions: Child, Only, Brain Diseases, Sickle Cell Disease, Anemia, Sickle Cell. Basic parameters: 4 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Drug Carbon Dioxide
    Participants inhale carbon dioxide while in magnetic resonance imaging scan to measure cerebrovascular reactivity

Primary outcome measures

  • Gray Matter cortical thickness [Time frame: 3 years]
Secondary outcome measures (2)
  • Total Brain volume [Time frame: 3 years]
  • Cerebrovascular Reactivity [Time frame: 15 minutes]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Washington University in St. Louis — St Louis

Identifiers

NCT: NCT04406818 · 202106016 · R01NS121065

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗