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Functional Evaluation in Patients With Urea Cycle Disorders (UCD) During a Driving Task

29 de julho de 2026 atualizado por: St. Jude Children's Research Hospital

Cognitive and Motor Function Examination in Patients With Urea Cycle Disorders (UCD) During a Driving Task Using Functional Near Infrared Spectroscopy (fNIRS)

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.

Visão geral do estudo

Status

Recrutamento

Condições

Distúrbio do Ciclo da Uréia

Descrição detalhada

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.

Participants 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.

All study activities will be completed on the day of enrollment.

Tipo de estudo

Observacional

Inscrição (Estimado)

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Jean Laboe, RN
Número de telefone: 901-595-1693
E-mail: jean.laboe@stjude.org

Locais de estudo

Estados Unidos
- Tennessee
  - Memphis, Tennessee, Estados Unidos, 38105
    - Recrutamento
    - St. Jude Children's Research Hospital
    - Contato:
      
      Jean Laboe, RN
      
      Número de telefone: 901-595-1693
      
      E-mail: jean.laboe@stjude.org

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Filho
Adulto

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

Individuals who meet the Eligibility Criteria and agree to participate.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
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 Prazo: 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.	Day 1, during driving simulator task

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
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 Prazo: Day 1, during driving simulator task	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.	Day 1, during driving simulator task

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

St. Jude Children's Research Hospital

Investigadores

Investigador principal: Andrea Gropman, M.D., St. Jude Children's Research Hospital

Publicações e links úteis

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Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de julho de 2026

Conclusão Primária (Estimado)

1 de agosto de 2031

Conclusão do estudo (Estimado)

1 de agosto de 2032

Datas de inscrição no estudo

Enviado pela primeira vez

8 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ