RecruitingNot Applicable

Functional Evaluation in Patients With Urea Cycle Disorders (UCD) During a Driving Task

United States60 participantsStarted 2026-07-20

Plain-language summary

This study is being done to understand how the brain works while people with urea cycle disorder (UCD) perform driving tasks that range from easy to difficult and to look at how that compares to traditional tests of thinking and attention.

Who can participate

Age range

16 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in Oxyhemoglobin (HbO), Deoxyhemoglobin (HbR) and Total Hemoglobin (HbT) concentrations in the right and left prefrontal cortex in participants with urea cycle disorders (UCD) compared to healthy control volunteers

Timeframe: Day 1, during driving simulator task

Trial details

NCT IDNCT07701694

SponsorSt. Jude Children's Research Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2031-08

Contact for this trial

Jean Laboe, RN

901-595-1693 jean.laboe@stjude.org

View on ClinicalTrials.gov More Urea Cycle Disorder trials

Who can participate

Age range

16 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.