Cognitive and Motor Function Examination in Patients With Urea Cycle Disorders (UCD) During a Driving Task Using Functional Near Infrared Spectroscopy (fNIRS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
Primary Objective
- 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).
Secondary Objective
- 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).
This 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
结局指标
主要结局
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
时间窗: Day 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.
次要结局
- 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(Day 1, during driving simulator task)