RecruitingNCT02935283

Neuroimaging and Neuropsychological Outcomes in Urea Cycle Disorders


Sponsor

Children's National Research Institute

Enrollment

56 participants

Start Date

Aug 1, 2016

Study Type

OBSERVATIONAL

Conditions

Summary

In proximal urea cycle disorders (UCD), particularly ornithine transcarbamylase deficiency (OTCD), hyperammonemia (HA) causes increased brain glutamine (Gln) which perturbation is thought to be at the core of the neurological injury. In contrast, in distal UCD such as citrullinemia (argininosuccinate synthetase deficiency; (ASSD) and argininosuccinic aciduria (argininosuccinate lyase deficiency); (ASLD) cognitive impairment and neuropsychiatric disease are common even in the absence of acute HA. As a consequence, both citrulline and argininosuccinate (ASA) or their metabolic products have been implicated as neurotoxic. In this project the investigators will use state-of- the-art neuroimaging and neuropsychological methods to investigate whether patients with OTCD have chronically elevated brain Gln and reduced myo-inositol (mI) levels that correlate with regional brain structural abnormalities and neurocognitive dysfunction. The researchers will further investigate whether during an acute episode of HA elevated brain Gln and decreased mI levels correlate with the magnitude of cytotoxic edema and whether a Gln/mI ratio threshold can be identified at which the cytotoxic edema is followed by cell loss. Finally, the researchers will investigate whether regions of brain damage in ASSD and/or ASLD are distinct from those in OTCD and compare brain Gln levels in ASSD and ASLD in the absence of HA to those in OTCD. The investigators will also seek to determine if brain citrulline and ASA can be identified in the brains of patients with distal UCD and whether they correlate with brain abnormalities seen in MRI and neuropsychological testing. This project will elucidate the chronology of brain pathology both in acute hyperammonemia and chronic UCD and whether, proximal and distal UCD differ in their pathophysiology of brain damage.


Eligibility

Min Age: 7 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study uses advanced brain imaging (MRI) and neuropsychological testing to understand how high ammonia levels and urea cycle disorders (UCDs) — rare genetic conditions affecting the body's ability to remove ammonia — affect the brain. By imaging the brain during and after ammonia crises, researchers hope to understand the neurological damage these events cause and find ways to prevent it. You may be eligible if: - You are between 7 and 50 years old (the exact range depends on which group you qualify for) - You have a confirmed diagnosis of ornithine transcarbamylase deficiency (OTCD), arginosuccinate synthetase deficiency (ASSD), or arginosuccinate lyase deficiency (ASLD) — OR you are a healthy age/gender-matched control - You are able to undergo MRI without sedation - If participating in the crisis group: you are currently hospitalized with elevated ammonia (100–300 µM) and are awake and medically stable You may NOT be eligible if: - You cannot undergo MRI without sedation, or you have metal implants (including orthodontic braces) - You are medically unstable - Your ammonia level is below 100 µM or above 300 µM (for the crisis group) - You are pregnant - You are unconscious or unable to maintain your own airway Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREMRI

MRI, fMRI, 1H MRS, DTI

BEHAVIORALBehavioral

Battery of executive function tasks


Locations(1)

Children's Research Institute

Washington D.C., District of Columbia, United States

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NCT02935283


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