Skip to main content
OpenTrials
Completed

NCT Number: NCT01753921

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be eligible for the study, all subjects must meet the following criteria:

  • Healthy control OR
  • Clinical new onset or established diagnosis of diabetes with diabetes ketoacidosis as defined by the Pediatric Endocrine Society Consensus Statement guidelines
  • Age 10 years to less than 17 years
  • Parent/guardian understand the study protocol and agrees to comply with it.
  • 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:

  • History of head trauma with any loss of consciousness
  • History of premature birth (less than 30 weeks of gestation)
  • History of significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age
  • History of neurologic disease independent of diabetes (seizure disorder)

Treatment and study plan

This is not an intervention study

Other

Subjects will wear the headband/helmet-like device for approximately 10 minutes on four different occasions: t=0, t=1week, t=1month, t=3months. Of note, part of the device also involves electrodes that are worn to obtain an electrocardiogram or EKG.

MRI

Device

MRI study of the brain will be performed at t=3months.

Primary outcomes

  1. Unique signal measured in Hertz

    Time frame: 3 months

    We will be using the brain compliance measurement device to see if there is a unique signal for those with DKA and if so, follow the duration of this signal.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Jan Medical, Inc.

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Dec 20, 2012
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.