Evaluation of a Non-invasive Brain Compliance Measurement Device

Stanford University

Status: Completed

Conditions: Diabetes; Diabetic Ketoacidosis

Treatments: Other: this is not an intervention study; Device: MRI

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01753921

22727

Details and patient eligibility

About

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.

Full 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

Enrollment: 14 patients

Sex: All

Ages: 10 to 16 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

14 participants in 2 patient groups

DKA Group

Description:

Subjects who presented in diabetic ketoacidosis.

Treatment:

Device: MRI

Other: this is not an intervention study

Other: this is not an intervention study

Healthy control

Description:

Control subjects without diabetes.

Treatment:

Device: MRI

Other: this is not an intervention study

Other: this is not an intervention study