Evaluation of a Non-invasive Brain Compliance Measurement Device
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 10 - 16 |
| Updated: | 4/21/2016 |
| Start Date: | November 2011 |
| End Date: | July 2020 |
| Contact: | Tandy Aye, MD |
| Email: | taye@stanford.edu |
| Phone: | 650-723-5791 |
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.
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.
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
NNS
MRI of the brain at 3 month and 12 months
Formal neurocognitive testing at 3 months and 12 months
Inclusion Criteria:
To be eligible for the study, all subjects must meet the following criteria:
1. Healthy control OR
2. Clinical new onset or established diagnosis of diabetes with diabetes ketoacidosis as
defined by the Pediatric Endocrine Society Consensus Statement guidelines
3. Age 10 years to less than 17 years
4. Parent/guardian understand the study protocol and agrees to comply with it.
5. 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.
Exclusion Criteria:
Subjects who meet any of the following criteria are not eligible for the study:
1. History of head trauma with any loss of consciousness
2. History of premature birth (less than 30 weeks of gestation)
3. History of significant developmental delay (lack of single word speech or ability to
walk independently by 18 months of age
4. History of neurologic disease independent of diabetes (seizure disorder)
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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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