Evaluation of a Non-invasive Brain Compliance Measurement Device
8. november 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
14
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
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Stanford, California, Forenede Stater, 94305
- Stanford University
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
10 år til 16 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Children between 10-16 with DKA
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
DKA Group
Subjects who presented in diabetic ketoacidosis.
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Unique signal measured in Hertz
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Tandy Aye, MD, Stanford University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2011
Primær færdiggørelse (Faktiske)
1. oktober 2016
Studieafslutning (Faktiske)
1. oktober 2016
Datoer for studieregistrering
Først indsendt
18. september 2012
Først indsendt, der opfyldte QC-kriterier
17. december 2012
Først opslået (Skøn)
20. december 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. november 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. november 2019
Sidst verificeret
1. november 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 22727
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .