Cerebrovascular Reactivity Measurements With High-Density Diffuse Optical Tomography

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07776444
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Carbon Dioxide — OTHER
    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.

Study Details

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.

Key Dates

First listed
Aug 20, 2026
Start date
Oct 1, 2025
Status verified
Aug 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2032

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Healthy Controls
  • Active Comparator: Sickle Cell Anemia Participants

Primary Outcome Measure

HDDOT-Based Cerebrovascular Reactivity [ Time Frame: ~15 minutes during the MRI scan and ~60 minutes during the HDDOT imaging. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University in St. LouisSt LouisMissouri63110
Kristin Guilliams, MD
[email protected]
3144546120
Kristin Guilliams, MD (PRINCIPAL_INVESTIGATOR)
Adam Eggebrecht (PRINCIPAL_INVESTIGATOR)

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