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Can a light cap predict stroke in sickle cell disease?

NCT ID NCT07776444

Knowledge-focused Sponsor: Washington University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study is testing whether a light-based cap (HD-DOT) can measure how well the brain responds to changes in carbon dioxide, a key indicator of stroke risk. Researchers will compare this cap to standard MRI in people with and without sickle cell disease, aged 6 to 70. Participants may also undergo cognitive tests and blood draws, and be followed for up to three years. The goal is to find a simpler, safer way to identify those at risk for stroke.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Carbon dioxide inhalation and high-density diffuse optical tomography (HD-DOT) imaging
What this could lead to
If successful, this could lead to a safer, more accessible way to identify children with sickle cell disease who are at high risk of stroke, enabling earlier prevention.
What could go wrong
This is an early feasibility study, so the optical cap may not match MRI accuracy. It also involves inhaling carbon dioxide, which carries some risk, especially in vulnerable patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Sep 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

cerebral infarction sickle cell disease stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cerebral stroke Sickle cell disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Washington University in St. Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

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