CompletedNot Applicable

Investigation of Brain Nitrogen in Partial Ornithine Transcarbamylase Deficiency (OTCD) Using 1 H MRS, DTI, and fMRI

49 participantsStarted 2010-09

Plain-language summary

The purpose of this study is to use various types of MRI and cognitive testing to evaluate changes in the brain and cognitive function that occur in subjects with ornithine transcarbamylase deficiency (OTCD) relative to healthy individuals

Who can participate

Age range7 Years – 60 Years

SexALL

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Inclusion criteria

✓. Patients with OTCD;
✓. Age range: 7-60 years
✓. Able to undergo neuroimaging safely (i.e. without presence of ferromagnetic devices)
✓. Subject has a documented full scale IQ \> 70
✓. Healthy males and females without metabolic disease aged 7-60 years
✓. Subject has a documented full scale IQ \> 70

Exclusion criteria

✕. Mental retardation (i.e., Full Scale IQ\< 70)
✕. Age range \<7 or \>60 years
✕. Presence of ferromagnetic device(s) that preclude safe imaging
✕. Pregnant female
✕. Subjects with a documented history of an intellectual deficit (i.e., Full Scale IQ\< 70)
✕. Age range \<7 or \>60 years
✕. Presence of ferromagnetic device(s) that preclude safe imaging
✕. Pregnant female

What they're measuring

Concentration of Glutamine and Myoinositol

Timeframe: Baseline

Functional Connectivity of Assessed by Resting-state fMRI

Timeframe: Baseline

Fractional Anisotropy Assessed Using DTI

Timeframe: Baseline

Trial details

NCT IDNCT01569568

SponsorAndrea Gropman

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-08

Results submitted2015-06-30

View on ClinicalTrials.gov More Ornithine Transcarbamylase Deficiency trials