MRI Spectroscopy and Neuropsychological Functioning in Phenylketonuria

Completed

Conditions studied: Phenylketonuria

In brief

This is a study about the relationship of brain biomarkers with neuropsychological functioning in PKU. All participants will undergo MRI spectroscopy, will provide a blood specimen and will receive neuropsychological testing.

Key facts

Study ID

NCT03097250

Run by

Boston Children's Hospital

People needed

10

Starts

2017-10-25

Expected to finish

2018-07-01

Last updated by the study team

2018-10-19

Who can join

Age: 12 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 12-25 years
• Not currently participating in a clinical trial
• Capable of providing informed assent/consent
• Able to undergo MRI procedures without sedation
• Does not have metal implants (braces or permanent retainers made of MRI-compatible materials are permitted since we will not be doing procedures, such as DTI, affected by non-ferrous metals).
• PKU Group: identified by newborn screening; received treatment within the first 30 days of life
• PKU Group: Pre-treatment/off-diet blood Phe concentration at or above 600 umol/L

You may not qualify if…

• Older than 25 years or younger than 12 years of age.
• Currently participating in a clinical trial
• Incapable of providing informed assent/consent
• Pregnant women will be excluded
• Not able to tolerate MRI procedures without sedation
• Has metal implants or braces on teeth not compatible with MRI
• Has any known contraindication for MRI
• PKU Group: Pre-treatment/off-diet blood Phe concentration below 600 umol/L)
• PKU Group: Not identified through newborn screening or treatment was initiated after 30 days of life

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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