Trial record 10 of 15 for:    "Diabetic Ketoacidosis"

Evaluation of a Non-invasive Brain Compliance Measurement Device

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Stanford University
Sponsor:
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
  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:

  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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014