Evaluation of a Non-invasive Brain Compliance Measurement Device

NCT ID: NCT01753921

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2016-10-31

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.

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

Conditions

Diabetes; Diabetic Ketoacidosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

DKA Group

Subjects who presented in diabetic ketoacidosis.

this is not an intervention study

Intervention Type: 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.

this is not an intervention study

Intervention Type: OTHER

Subjects will be asked to participate in both computerized and non-computerized tests to assess subjects' cognitive (learning, language and memory) abilities, developmental level, and behavior. Tests will take place at t=0, t=1week, t=1month, t=3months.

MRI

Intervention Type: DEVICE

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

Healthy control

Control subjects without diabetes.

this is not an intervention study

Intervention Type: 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.

this is not an intervention study

Intervention Type: OTHER

Subjects will be asked to participate in both computerized and non-computerized tests to assess subjects' cognitive (learning, language and memory) abilities, developmental level, and behavior. Tests will take place at t=0, t=1week, t=1month, t=3months.

MRI

Intervention Type: DEVICE

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

Interventions

this is not an intervention study

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.

Intervention Type: OTHER

this is not an intervention study

Subjects will be asked to participate in both computerized and non-computerized tests to assess subjects' cognitive (learning, language and memory) abilities, developmental level, and behavior. Tests will take place at t=0, t=1week, t=1month, t=3months.

Intervention Type: OTHER

MRI

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jan Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Tandy Aye

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tandy Aye, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Related Links

http://dped.stanford.edu/research/

Related Info

Other Identifiers

22727

Identifier Type: -

Identifier Source: org_study_id