Trial Search Results

Evaluation of a Non-invasive Brain Compliance Measurement Device

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Jan Medical, Inc.

Stanford Investigator(s):

Intervention(s):

  • Other: this is not an intervention study
  • Other: this is not an intervention study
  • Device: MRI

Eligibility


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)

Ages Eligible for Study

10 Years - 16 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Tandy Aye, MD
650-723-5791