RecruitingNCT07701694
Functional Evaluation in Patients With Urea Cycle Disorders (UCD) During a Driving Task
Cognitive and Motor Function Examination in Patients With Urea Cycle Disorders (UCD) During a Driving Task Using Functional Near Infrared Spectroscopy (fNIRS)
Sponsor
St. Jude Children's Research Hospital
Enrollment
60 participants
Start Date
Jul 15, 2026
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 16 YearsMax Age: 40 Years
Inclusion Criteria4
- 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 Criteria11
- 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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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07701694