Active — Not RecruitingNot Applicable

Diffusion Tensor Imaging (DTI) in Infants With Krabbe Disease

United States100 participantsStarted 2008-04

Plain-language summary

This study is designed to learn about early brain development in children with Krabbe disease, and to use diffusion tensor imaging as an early diagnostic tool to identify newborns at risk for the disease.

Who can participate

Age range17 Years

SexALL

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Inclusion criteria

✓. Positive newborn screening test (low galactocerebrosidase)
✓. Infantile Krabbe Disease diagnosed by confirmatory low levels of residual enzyme by Dr. Wenger's Lysosmal Storage Diseases laboratory at Jefferson's Medical College (contracted by New York State) and/or carrier status established because of family history of Krabbe Disease. Patients have to be less than 6 weeks old at the time of the first assessment
✓. Children at risk of developing motor disability

Exclusion criteria

✕. Diagnosis or physical signs of known genetic conditions or syndromes, serious medical or neurological conditions affecting growth and development (e.g., seizure disorder, diabetes, congenital heart disease) or sensory impairments such as vision or hearing loss
✕. Children who may have suffered serious perinatal brain damage, children with birth weights less than 2000 grams and/or gestational ages of less than 34 weeks, or those with a history of intraventricular hemorrhage
✕. Children who may have a contraindication for MRI (pacemaker, vascular stents, metallic ear tubes, other metal implants or braces).

What they're measuring

Diffusion tensor imaging (DTI) of corticospinal tracts

Timeframe: at birth, 1 year and 2 years of age

Trial details

NCT IDNCT00787865

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-04

View on ClinicalTrials.gov More Krabbe Disease trials