Recruiting

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT04157179

Conditions

Sickle Cell Disease

Cerebral Stroke

Eligibility Criteria

Sex: All

Age: 3 - 50

Healthy Volunteers: Accepted

Interventions

Carbon Dioxide

Study Details

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.

We 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 can do varies by age. The brain's blood flow changes in small ways during everyday activities, such as normal brain growth, exercise, or deep concentration. 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 as much oxygen as it wants may cause the brain to grow and develop more slowly than it should.

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, and potential neuropsychological assessments. It is also possible that the study team will use a special mask to control the amount of carbon dioxide the participants breathe in so they don't breathe in too much.

Conditions

Sickle Cell Disease

Cerebral Stroke

Study ID

NCT04157179

Start date

Oct 17, 2019

Status verified date

Sep, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 50

Healthy Volunteers: Accepted

Healthy Controls:

  • Healthy controls ages 3-50 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 3-50 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

Extracorporeal Membrane Oxygenation (ECMO) Survivors:

  • Ages 3-50 years of age
  • History of cannulation for ECMO
  • Able to participate in MRI scan without sedation
  • Not currently pregnant
  • Not on vasodilatory medication, such as sildenafil or verapamil

Study Design

Enrollment

350 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Healthy Controls

active comparator: Extracorporeal Membrane Oxygenation survivors

active comparator: Sickle Cell Anemia participants

Interventions

Carbon Dioxide

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

Primary outcome measure

  • Cerebral Oxygen Metabolism [ Time Frame: From the beginning of the MRI scan to the completion of the MRI scan -- 75 minutes. ]

Central Contacts and Locations

Central contacts

Kristin Guilliams, MD

3144546120kristinguilliams@wustl.edu

Locations

Washington University of St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Kristin Guilliams, MD

3144546120kristinguilliams@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Sep 11, 2025

Last verified

Sep, 2025

Keywords

  • extracorporeal membrane oxygenation
  • cerebrovascular reactivity
  • sickle cell disease
  • healthy controls
  • magnetic resonance imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-09-11.