Metabolic and Hemodynamic Reserve in Pediatric SCA

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-21
SponsorWashington University School of Medicine

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carbon Dioxide

    Drug

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Healthy ControlActive comparator 1 intervention
Group B: Sickle Cell AnemiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Gray Matter cortical thickness

Mean whole brain cortical thickness on high resolution T1 images

Time frame
3 years

Secondary outcomes

1

Total Brain volume

Total brain volume (gray matter and white matter) on high resolution T1 image

Time frame
3 years
2

Cerebrovascular Reactivity

Change in blood flow as measured by MRI in response to carbon dioxide

Time frame
15 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator