Evaluation of a Non-invasive Brain Compliance Measurement Device

NCT01753921 | Completed

• 1 other identifier: 22727
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; Diabetic Ketoacidosis

Outcome Measures

Primary Outcomes (1)

• Unique signal measured in Hertz

  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.

  3 months

Study Arms (2)

DKA Group

Subjects who presented in diabetic ketoacidosis.

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

Healthy control

Control subjects without diabetes.

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

Interventions

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.

DKA Group; Healthy control

MRI DEVICE

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

DKA Group; Healthy control

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children between 10-16 with DKA

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead
• Jan Medical, Inc.: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Ketoacidosis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Ketosis; Acidosis; Acid-Base Imbalance; Diabetes Complications

Study Officials

• Tandy Aye, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: December 20, 2012
• Study Start: November 1, 2011
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

US (1)