Evaluation of a Non-invasive Brain Compliance Measurement Device

Completed

Conditions studied: Diabetes, Diabetic Ketoacidosis

In brief

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.

Key facts

Study ID

NCT01753921

Run by

Stanford University

People needed

14

Starts

2011-11-01

Expected to finish

2016-10-01

Last updated by the study team

2019-11-13

Who can join

Age: 10 and older, up to 16. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• To be eligible for the study, all subjects must meet the following criteria:
• Healthy control OR
• Clinical new onset or established diagnosis of diabetes with diabetes ketoacidosis as defined by the Pediatric Endocrine Society Consensus Statement guidelines
• Age 10 years to less than 17 years
• Parent/guardian understand the study protocol and agrees to comply with it.
• Primary care giver (i.e parent/guardian) comprehends written English. This is due to the fact that questionnaires and neurocognitive testing tools used as outcome measures do not have validated versions in Spanish or other language. Subject comprehends and speaks English.

You may not qualify if…

• Subjects who meet any of the following criteria are not eligible for the study:
• History of head trauma with any loss of consciousness
• History of premature birth (less than 30 weeks of gestation)
• History of significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age
• History of neurologic disease independent of diabetes (seizure disorder)

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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