Cerebrovascular Reactivity Measurements With High-Density Diffuse Optical Tomography

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-70
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Carbon Dioxide

    Other intervention

    Participants inhale carbon dioxide, delivered by computer-controlled delivery system, to target specific levels of carbon dioxide while in magnetic resonance imaging scan and/or during HDDOT imaging to measure cerebrovascular reactivity.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Healthy ControlsActive comparator 1 intervention
Group B: Sickle Cell Anemia ParticipantsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

HDDOT-Based Cerebrovascular Reactivity

Changes in relative concentration of deoxyhemoglobin with fluctuations of carbon dioxide as compared to gold standard measurement of MRI-based cerebrovascular reactivity.

Time frame
~15 minutes during the MRI scan and ~60 minutes during the HDDOT imaging.

Secondary outcomes

1

Cerebral Oxygen Metabolism

MRI-based cerebral based blood flow oxygen extraction fraction will be combined with laboratory data estimating arterial oxygen content to calculate cerebral oxygen metabolism.

Time frame
From administration of carbon dioxide to end of inhalation of carbon dioxide -- 60 minutes during MRI and/or HDDOT imaging.

Other outcomes

Sponsors and contacts

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