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Evaluation of a Non-invasive Brain Compliance Measurement Device
NCT01753921 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE MRI
- OTHER this is not an intervention study
Study Locations (1)
California
- Stanford University — Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2011-11 |
| Est. Completion | 2016-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01753921
The ClinicalTrials.gov registry entry for NCT01753921 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,643 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 2 interventions — of which MRI is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01753921 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01753921 about?
NCT01753921 is a clinical study titled "Evaluation of a Non-invasive Brain Compliance Measurement Device". 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/h...
What is the current status of trial NCT01753921?
This trial is currently completed. The enrollment target is 14 participants. The study started on 2011-11. Estimated completion is 2016-10.
What conditions does trial NCT01753921 study?
This clinical trial studies the following conditions: Diabetes, Diabetic Ketoacidosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01753921?
The interventions under investigation include: MRI (DEVICE), this is not an intervention study (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01753921?
This trial is sponsored by Stanford University, which has 1,643 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01753921 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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