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

This study aims to understand how the brain works when people with urea cycle disorders (UCD) perform driving tasks, from easy to difficult. Researchers will compare brain activity in individuals with UCD to healthy volunteers using a special brain scan called fNIRS (functional near-infrared spectroscopy). This scan measures changes in oxygen levels in the brain while you are in a driving simulator. The study will also compare these brain activity measurements to results from traditional thinking and attention tests. This is an observational study, meaning there are no interventions or treatments being tested. We are looking for 60 participants, aged 16 to 40, who have a confirmed UCD or are healthy volunteers.

Study design
This is an observational study comparing 60 participants with urea cycle disorders to healthy volunteers. It uses fNIRS brain scans during a driving task.
What's involved
You would have your medical history collected, a basic neurological exam, and answer questions about your health, diet, and driving habits. You would also complete some simple thinking and memory tests and perform a driving simulator task while undergoing fNIRS brain scans.
Compensation
Not stated in the trial record.
Follow-up
Brain activity will be measured during the driving simulator task on Day 1. No further follow-up is specified.

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NCT07701694

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

Recruiting
Not specifiedAges 16–40Observational
St. Jude Children's Research Hospital
~60 participants
Updated 2026-07-31 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
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
Measured over Day 1, during driving simulator task

Conditions

Urea Cycle Disorder

Explore related trials

Healthy VolunteersUrea Cycle Metabolism Disorder

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Andrea Gropman, M.D. · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

Jean Laboe, RN
[email protected]
901-595-1693
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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 volunteersDay 1, during driving simulator task

    Investigators will compare prefrontal cortex hemoglobin concentrations during low cognitive load between patients with UCD and healthy age and sex matched control participants using functional near-infrared spectroscopy (fNIRS). Mean values of hemoglobin concentration differences on the right and left prefrontal cortex between individuals, with and without UCD, during the low cognitive load task will be calculated and compared using two sample t-tests (for normally distributed data) or Wilcoxon rank sum tests (for nonnormally distributed data). P values will be adjusted for multiple comparisons using the Bonferroni method.