Metabolic and Hemodynamic Reserve in Pediatric SCA

Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT04406818
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
120
1
2
57.5
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Carbon Dioxide
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Role of Metabolic and Hemodynamic Reserve in Age-Related Brain Vulnerability in Pediatric Sickle Cell Anemia
Actual Study Start Date :
Jun 15, 2021
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Mar 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Healthy Control

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

Active Comparator: Sickle Cell Anemia

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

Outcome Measures

Primary Outcome Measures

  1. Gray Matter cortical thickness [3 years]

    Mean whole brain cortical thickness on high resolution T1 images

Secondary Outcome Measures

  1. Total Brain volume [3 years]

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

  2. Cerebrovascular Reactivity [15 minutes]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University in St. Louis Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine
  • National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Kristin P Guilliams, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT04406818
Other Study ID Numbers:
  • 771237
  • R01NS121065
First Posted:
May 28, 2020
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Washington University School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2022