Evaluation of a Non-invasive Brain Compliance Measurement Device

Status Completed

Clinical Trial Summary

This is a research study to understand how diabetic ketoacidosis may affect the brain and learning and to see if these changes are transient or permanent. The investigators hope to learn more about how diabetic ketoacidosis may cause changes in brain compliance (by wearing a non-invasive head band/helmet like device from Jan Medical: The Nautilus Neurowave System™ (NNS), learning, talking, behavior, or development. The investigators will compare those results from those with diabetes mellitus to those age and gendered matched healthy controls. Possible subjects in this study have diabetes mellitus and are between the ages of 10 to less than 17 years old OR do NOT have diabetes and are between the ages of 10 to less than 17 years old.

Clinical Trial Description

At enrollment, 1 week, 1 month, 3 month, 12 month Computerized neurocognitive testing Wear NNS

MRI of the brain at 3 month and 12 months

Formal neurocognitive testing at 3 months and 12 months ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01753921
Study type	Observational
Source	Stanford University
Contact
Status	Completed
Phase
Start date	November 2011
Completion date	October 2016

View Details

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