Evaluation of a Non-invasive Brain Compliance Measurement Device
This study is currently recruiting participants.
Verified December 2012 by Stanford University
Sponsor:
Stanford University
Collaborator:
Jan Medical
Information provided by (Responsible Party):
Tandy Aye, Stanford University
ClinicalTrials.gov Identifier:
NCT01753921
First received: September 18, 2012
Last updated: December 17, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Diabetic Ketoacidosis |
Device: Nautilus Neurowave System™ (NNS) Device: Cognitive testing Device: MRI |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Evaluation of a Non-invasive Brain Compliance Measurement Device |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Unique signal measured in Hertz [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2011 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DKA Group
Subjects who presented in diabetic ketoacidosis.
|
Device: Nautilus Neurowave System™ (NNS)
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.
Device: Cognitive testing
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.
|
|
Active Comparator: Healthy control
Control subjects without diabetes.
|
Device: Nautilus Neurowave System™ (NNS)
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.
Device: Cognitive testing
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.
|
Eligibility| Ages Eligible for Study: | 10 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753921
Contacts
| Contact: Tandy Aye, MD | 650-723-5791 | taye@stanford.edu |
Locations
| United States, California | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Tandy Aye, MD 650-723-5791 taye@stanford.edu | |
Sponsors and Collaborators
Stanford University
Jan Medical
Investigators
| Principal Investigator: | Tandy Aye, MD | Stanford University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Tandy Aye, Assistant Professor, Stanford University |
| ClinicalTrials.gov Identifier: | NCT01753921 History of Changes |
| Other Study ID Numbers: | 22727 |
| Study First Received: | September 18, 2012 |
| Last Updated: | December 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetic Ketoacidosis Ketosis Acidosis Acid-Base Imbalance Metabolic Diseases |
Diabetes Mellitus Glucose Metabolism Disorders Diabetes Complications Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013