[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07701694":3,"trial-entities:NCT07701694":96,"trial-summary:NCT07701694":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":33,"secondary_outcomes":38,"sex":42,"minimum_age":43,"maximum_age":44,"healthy_volunteers":45,"eligibility_criteria":46,"std_ages":65,"locations":68,"central_contacts":83,"overall_officials":85,"references":89,"see_also_links":90},"NCT07701694","DRIVEUCD","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)","RECRUITING","2032-08","2026-07","2026-07-31","2026-07-20","St. Jude Children's Research Hospital","OTHER",false,"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.","Primary Objective\n\n* To use fNIRS to study brain functional behavior in subjects with UCD by measuring the changes in HbO, HbR and HbT concentrations versus healthy control volunteers during the baseline driving task on the left and right prefrontal cortex (LPFC, RPFC).\n\nSecondary Objective\n\n* To include other cortical regions such as temporal and occipital regions, to investigate the neurocognitive changes in these regions which may or may not change with driving. Thus, we will measure changes in HbO, HbR and HbT concentrations during the baseline driving task in four more brain regions (left and right parietal and occipital regions, LPA, RPA, LOL, ROL).\n\nThis is a non-therapeutic, non-interventional study in which brain fNIRS (functional near-infrared spectroscopy) measures will be compared under simulated driving conditions between patients with UCD vs. age and sex-matched control participants.\n\nParticipants who agree to participate will have Information about their medical history collected, have a basic neurological exam and answer questions about their health, diet, and driving habits. They will complete some simple thinking and memory tests. These tests will help investigators understand skills like memory, attention, and problem-solving. Participants will also wear a soft cap with small sensors called an fNIRS (functional near-infrared spectroscopy) device while they complete a driving simulator activity. This cap is noninvasive and measures how the brain uses oxygen while they drive in the simulator.\n\nAll study activities will be completed on the day of enrollment.",[19],"Urea Cycle Disorder",[21,22,23,24,25],"Participants with Urea Cycle Disorder","Healthy Volunteers","Cognitive function examination","Motor function examination","Simulated driving task with functional near-infrared spectroscopy monitoring","OBSERVATIONAL",null,[],{"count":30,"type":31},60,"ESTIMATED",[],[34],{"measure":35,"description":36,"timeFrame":37},"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","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.","Day 1, during driving simulator task",[39],{"measure":40,"description":41,"timeFrame":37},"Changes in HbO, HbR and HbT concentrations in the left and right parietal and occipital brain regions in participants with urea cycle disorders (UCD) compared to healthy control volunteers","Investigators will compare left and right parietal and occipital regions 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 left and right parietal and occipital regions 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.","ALL","16 Years","40 Years",true,{"inclusion":47,"exclusion":52,"raw_text":64},[48,49,50,51],"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.",[53,54,55,56,57,58,59,60,61,62,63],"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\u002For 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","Inclusion Criteria:\n\n* Individuals 16 to 40 years with molecular or biochemical confirmation of a urea cycle disorder.\n* Healthy individuals will serve as an age and sex matched comparison group. Active driver's license for at least 6 months\n* Read and understand English. as the tasks have not been validated in other languages\n* IQ \\>=70.\n\nExclusion Criteria:\n\n* Skin disease that affects the scalp\n* Past or present vascular disease\n* Head trauma with loss of consciousness in the last year or evidence of cognitive impairment due to and persisting after head trauma\n* Motor movement disorder which may cause excessive movement or impede use of the steering wheel and\u002For pedal\n* Premature birth or birth before 32 weeks of gestation\n* The participant is taking a stimulant or antidepressant\n* Allergy to any component of the device, although expected to be rare\n* History of psychosis\n* Self-reported motion or cyber sickness\n* Self-reported illicit substance use\n* Vision disorder",[66,67],"CHILD","ADULT",[69],{"facility":13,"status":8,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":80},"Memphis","Tennessee","38105","United States",[75],{"name":76,"role":77,"phone":78,"email":79},"Jean Laboe, RN","CONTACT","901-595-1693","jean.laboe@stjude.org",{"lat":81,"lon":82},35.14953,-90.04898,[84],{"name":76,"role":77,"phone":78,"email":79},[86],{"name":87,"affiliation":13,"role":88},"Andrea Gropman, M.D.","PRINCIPAL_INVESTIGATOR",[],[91,93],{"label":13,"url":92},"http:\u002F\u002Fwww.stjude.org",{"label":94,"url":95},"Clinical Trials Open at St. Jude","http:\u002F\u002Fwww.stjude.org\u002Fprotocols",{"nct_id":4,"conditions":97,"biomarkers":99},[22,98],"Urea Cycle Metabolism Disorder",[],{"nct_id":4,"found":45,"summary":101,"prompt_version":111},{"design":102,"status":103,"heading":104,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This is an observational study comparing 60 participants with urea cycle disorders to healthy volunteers. It uses fNIRS brain scans during a driving task.","completed","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.","Brain activity will be measured during the driving simulator task on Day 1. No further follow-up is specified.",112,"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.","Not stated in the trial record.",[],"v2"]