Brain mapping of UCD patients during simulated driving

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers use functional near-infrared spectroscopy (fNIRS) to measure brain activity in people with urea cycle disorders and matched healthy volunteers as they complete driving tasks from easy to hard. The study also includes basic cognitive and memory tests and noninvasive brain monitoring during the driving scenario. It is non-therapeutic and non-interventional, focusing on brain function rather than treatment outcomes. Data will be collected from prefrontal, parietal, temporal, and occipital regions to explore neurocognitive changes related to driving performance.

Why it matters

Who can join: the full rules

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

Where it's running

• St. Jude Children's Research Hospital
  Memphis, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Andrea Gropman, M.D. — St. Jude Children's Research Hospital
• Study coordinator: Jean Laboe, RN
• Email: jean.laboe@stjude.org
• Phone: 901-595-1693

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.