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Cerebrovascular Reactivity Measurements With High-Density Diffuse Optical Tomography

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 70 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 years
  • Procedures mentioned: MRI scans, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Measuring OEF can be done with specialized MRI sequences."
  • "In order to deliver carbon dioxide evenly and as safely as possible, we will use RespirACT, an MRI-compatible device, to prevent over-breathing carbon dioxide and allow rapid steady-state physiology to minimize total scan time."
  • "This work will expand insights into mechanisms of stroke in children and assess the feasibility of the HD-DOT cap for obtaining these insights by comparing a cohort of optical CVR and a cohort of MRI CVR."
  • "In addition to the MRI and/or HD-DOT cap with RespirAct, participants may also have their vitals measured, complete cognitive testing, and complete a blood draw with a study visit."
  • "Participants may be followed for up to three years and may complete both an MRI scan and an HD-DOT scan within 1 week-12 months of each other."
  • "Participants may be invited back to repeat MRI and/or HD-DOT scans 1-2 times over the next three years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ways to measure how the brain uses oxygen and how its blood vessels respond to carbon dioxide. It compares MRI scans and a special light-based scanning cap to better understand stroke risk in children. People ages 6–70, with or without certain types of sickle cell anemia, may join.

The purpose of the study protocol is to identify imaging biomarkers for brain tissue under high metabolic stress at risk for permanent injury. We will measure oxygen extraction fraction (OEF) and cerebrovascular reactivity (CVR) in participants with and without perturbations in cerebral oxygen delivery over time to determine each parameter's role in clinical and radiologic neurologic outcomes. Measuring OEF can be done with specialized MRI sequences. Measuring CVR requires a vasoactive response, such as carbon dioxide. In order to deliver carbon dioxide evenly and as safely as possible, we will use RespirACT, an MRI-compatible device, to prevent over-breathing carbon dioxide and allow rapid steady-state physiology to minimize total scan time. We will also use a high density diffuse optical tomography (HD-DOT) cap to assess the measurement of OEF and CVR. This study will investigate both regional OEF and CVR simultaneously to understand each marker's unique developmental trajectory and contribution to stroke risk in children. This work will expand insights into mechanisms of stroke in children and assess the feasibility of the HD-DOT cap for obtaining these insights by comparing a cohort of optical CVR and a cohort of MRI CVR. In addition to the MRI and/or HD-DOT cap with RespirAct, participants may also have their vitals measured, complete cognitive testing, and complete a blood draw with a study visit. Participants may be followed for up to three years and may complete both an MRI scan and an HD-DOT scan within 1 week-12 months of each other. Participants may be invited back to repeat MRI and/or HD-DOT scans 1-2 times over the next three years.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 6–70 years old.
  • Be able to have an MRI scan without medicine to make you sleepy or keep you still.
  • May have or not have HbSS or sickle beta-zero thalassemia, two types of sickle cell anemia.

Who can't join

  • For light-based cap scans: major differences in the shape of the head or face, or technical problems that prevent use of the cap.
  • For MRI scans: metal in or on the body that makes an MRI unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 6-70 Years Old * Able to participate in MRI scan without sedation * May or may not have HbSS or beta thalassemia null genotypes of sickle cell anemia Exclusion Criteria: * Significant craniofacial malformation or technical contraindications to DOT monitoring (for HDDOT imaging) * Metal in/on the body that is contraindicated for MRI safety (for MRI imaging)

Study sites (1)

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