- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01753921
Evaluation of a Non-invasive Brain Compliance Measurement Device
November 8, 2019 updated by: Tandy Aye, Stanford University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Observational
Enrollment (Actual)
14
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 16 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children between 10-16 with DKA
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
DKA Group
Subjects who presented in diabetic ketoacidosis.
|
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.
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 study of the brain will be performed at t=3months.
|
Healthy control
Control subjects without diabetes.
|
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.
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 study of the brain will be performed at t=3months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unique signal measured in Hertz
Time Frame: 3 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tandy Aye, MD, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
September 18, 2012
First Submitted That Met QC Criteria
December 17, 2012
First Posted (Estimate)
December 20, 2012
Study Record Updates
Last Update Posted (Actual)
November 13, 2019
Last Update Submitted That Met QC Criteria
November 8, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22727
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
Oregon State UniversitySanofiCompletedType I or Type II Diabetes (Excludes Gestational Diabetes)
-
Taichung Veterans General HospitalNational Health Research Institutes, TaiwanRecruitingDiabetes Complications | Type 2 Diabetes | Maturity-Onset Diabetes of the Young (MODY)Taiwan
-
University of RoehamptonRecruitingType2 Diabetes Mellitus | Pre DiabetesUnited Kingdom
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
Clinical Trials on this is not an intervention study
-
Shanghai Mental Health CenterCompletedSchizophrenia | Cognitive Dysfunction | Neuroimaging
-
University College, LondonUniversity of LeedsUnknownMultimorbidityUnited Kingdom
-
University College, LondonUniversity of Leeds; Medical Research Council; University of EdinburghUnknownDementiaUnited Kingdom
-
Oslo University HospitalNot yet recruitingSchizophrenia | Cognitive Impairment | Social Competence
-
University of EdinburghKeele UniversityActive, not recruiting
-
Massachusetts General HospitalAstellas Pharma IncCompletedOveractive BladderUnited States
-
Danone Asia Pacific Holdings Pte, Ltd.Completed
-
King's College LondonNot yet recruitingCardiac Disease
-
Japan Cardiovascular Research FoundationUnknownAtrial Fibrillation | Stroke, AcuteJapan