Stanford University
Stanford, California, 94305, United States
NCT Number: NCT01753921
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.
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Notify Me10 year–16 year
All sexes
Observational
Stanford, California, 94305, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
To be eligible for the study, all subjects must meet the following criteria:
Exclusion criteria
Subjects who meet any of the following criteria are not eligible for the 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.
MRI study of the brain will be performed at t=3months.
Time frame: 3 months
We will be using the brain compliance measurement device to see if there is a unique signal for those with DKA and if so, follow the duration of this signal.
Stanford University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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