Evaluation of a Non-invasive Brain Compliance Measurement Device

Trial ID or NCT#

NCT01753921

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Evaluation of a Non-invasive Brain Compliance Measurement Device

Eligibility Criteria

Ages Eligible for Study: 10 to 16
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. To be eligible for the study, all subjects must meet the following criteria:
    1. 1. Healthy control OR2. Clinical new onset or established diagnosis of diabetes with diabetes ketoacidosis as defined by the Pediatric Endocrine Society Consensus Statement guidelines3. Age 10 years to less than 17 years4. 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.
  2. Exclusion Criteria:
  3. Subjects who meet any of the following criteria are not eligible for the study:
    1. 1. History of head trauma with any loss of consciousness2. 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 age4. History of neurologic disease independent of diabetes (seizure disorder)
Exclusion Criteria:
  1. Subjects who meet any of the following criteria are not eligible for the study:
    1. 1. History of head trauma with any loss of consciousness2. 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 age4. History of neurologic disease independent of diabetes (seizure disorder)
View All Criteria
Show Less

Investigator(s)

Tandy Aye

Contact us to find out if this trial is right for you.

Contact

Tandy Aye, MD
650-723-5791

View on ClinicalTrials.gov