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COMPLETED

Evaluation of a Non-invasive Brain Compliance Measurement Device

NCT01753921•Stanford University

Summary

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.

Detailed 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

Eligibility

Age

10 - 16 years

Sex

ALL

Healthy Volunteers

Yes

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

•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)

Locations (1)

Stanford University

Stanford, California, United States

Key Dates

Start Date

November 1, 2011

Primary Completion Date

October 1, 2016

Completion Date

October 1, 2016

Last Updated

November 13, 2019

Enrollment

ACTUAL participants

Conditions

DiabetesDiabetic Ketoacidosis

Interventions

this is not an intervention study

OTHER

this is not an intervention study

OTHER

MRI

DEVICE

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITING

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of a Non-invasive Brain Compliance Measurement Device

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Genetic Studies of Insulin and Diabetes

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