Recruiting

Observational Study

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07701694

Conditions

Urea Cycle Disorder

Eligibility Criteria

Sex: All

Age: 16 - 40

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Urea Cycle Disorder

Study ID

NCT07701694

Start date

Jul 20, 2026

Status verified date

Jul, 2026

Completion date

Aug, 2032

Anticipated

Primary completion date

Aug, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 40

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

UCD group

Participants with urea cycle disorders (UCD) who meet the Eligibility Criteria and consent to participate

Control group

Healthy controls who meet the Eligibility Criteria and consent to participate

Primary outcome measure

  • 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 [ Time Frame: Day 1, during driving simulator task ]

Central Contacts and Locations

Central contacts

Jean Laboe, RN

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

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Jean Laboe, RN

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

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • Participants with Urea Cycle Disorder
  • Healthy Volunteers
  • Cognitive function examination
  • Motor function examination
  • Simulated driving task with functional near-infrared spectroscopy monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-07-31.