NCT01753921

Evaluation of a Non-invasive Brain Compliance Measurement Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 10 Years – 16 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Diabetes
• Diabetic Ketoacidosis

Interventions

Type	Name	Description
OTHER	this is not an intervention study	Subjects will wear the headband/helmet-like device for approximately 10 minutes on four different occasions: t=0, t=1week, t=1month, t=3months. Of note, part of the device also involves electrodes that are worn to obtain an electrocardiogram or EKG.
OTHER	this is not an intervention study	Subjects will be asked to participate in both computerized and non-computerized tests to assess subjects' cognitive (learning, language and memory) abilities, developmental level, and behavior. Tests will take place at t=0, t=1week, t=1month, t=3months.
DEVICE	MRI	MRI study of the brain will be performed at t=3months.

Timeline

• Start date: 2011-11-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2012-12-20
• Last updated: 2019-11-13

Locations

1 site across 1 country: United States