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Brain scans reveal how urea cycle disorder affects driving ability

NCT ID NCT07701694

Knowledge-focused Sponsor: St. Jude Children's Research Hospital Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study uses a brain imaging technique called functional near-infrared spectroscopy (fNIRS) to observe brain activity in people with urea cycle disorder (UCD) while they perform driving tasks of varying difficulty. Researchers compare these brain patterns to those of healthy volunteers of the same age and sex. The goal is to understand how UCD affects cognitive and motor functions during a complex real-world activity like driving.

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.

Participants

About 60 people

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

Started

Jul 2026

Expected to finish

Aug 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.

Who is studied

Individuals who meet the Eligibility Criteria and agree to participate.

Ages

16 to 40 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: * Individuals 16 to 40 years with molecular or biochemical confirmation of a urea cycle disorder. * Healthy individuals will serve as an age and sex matched comparison group. Active driver's license for at least 6 months * Read and understand English. as the tasks have not been validated in other languages * IQ \>=70. Exclusion Criteria: * Skin disease that affects the scalp * Past or present vascular disease * Head trauma with loss of consciousness in the last year or evidence of cognitive impairment due to and persisting after head trauma * Motor movement disorder which may cause excessive movement or impede use of the steering wheel and/or pedal * Premature birth or birth before 32 weeks of gestation * The participant is taking a stimulant or antidepressant * Allergy to any component of the device, although expected to be rare * History of psychosis * Self-reported motion or cyber sickness * Self-reported illicit substance use * Vision disorder

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Conditions

The condition(s) this trial relates to.

urea cycle disorder

As listed by the trial registrant

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

Urea cycle disorder

How to take part

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  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

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Contacts and locations

Locations

  • St. Jude Children's Research Hospital

    RECRUITING

    Memphis, Tennessee, 38105, United States

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