Evaluation of a Non-invasive Brain Compliance Measurement Device

Diabetes Clinical Trial

Official title:

Evaluation of a Non-invasive Brain Compliance Measurement Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753921
• Other study ID #: 22727
• Status: Completed
• Start date: November 2011
• Est. completion date: October 2016

Study information

• Verified date: November 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Diabetic Ketoacidosis
• Ketosis

Intervention

Other:
• 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.
• 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.

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

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Jan Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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