- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02758496
En diagramgennemgang for at evaluere sikkerheden og effektiviteten af MeRT på emner med ASD
5. maj 2017 opdateret af: Wave Neuroscience
En diagramgennemgang for at evaluere sikkerheden og effektiviteten af magnetisk EEG/EKG-guidet resonansterapi (MeRT) på forsøgspersoner med autismespektrumforstyrrelse (ASD)
Formålet med denne undersøgelse er at evaluere sikkerheden og effektiviteten af magnetisk EEG/EKG-guidet resonansterapi (MeRT) på personer med autismespektrumforstyrrelse (ASD).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Dette er en retrospektiv diagramgennemgang af 200 på hinanden følgende diagrammer over forsøgspersoner i alderen 2-20 år, set på Brain Treatment Center mellem 2010 og 2015.
Gennemgangen er designet til at evaluere sikkerheden og effektiviteten af magnetisk elektroencefalogram/elektrokardiogram(EEG/EKG)-guidet resonansterapi (MeRT) på forsøgspersoner med autismespektrumforstyrrelse (ASD).
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
141
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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California
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Newport Beach, California, Forenede Stater, 92660
- Brain Treatment Center
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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
1 år til 16 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
To hundrede (200) mandlige og kvindelige forsøgspersoner af enhver etnisk baggrund i alderen 2-20 år set på Brain Treatment Center mellem 2010 og 2015.
Tyve (20) mandlige og kvindelige forsøgspersoner af enhver etnisk baggrund i alderen 2-20 år med neurotypiske EEG'er vil blive udvalgt til sammenligning med ASD-gruppen.
Beskrivelse
Inklusionskriterier:
- Skal have gennemført en baseline EEG på Brain Treatment Center (BTC)
- Alder mellem 2 og 20 år ved første besøg
- Skal have en diagnose af ASD i henhold til den gældende standard på det tidspunkt (dvs. Diagnostic and Statistical Manual-IV (DSM-IV)) (kun ASD Group)
Skal have modtaget magnetisk EEG/EKG-guidet resonansterapi (MeRT) i mere end (5) sessioner (kun ASD-gruppe)
Ekskluderingskriterier:
- Klinisk signifikant abnormitet eller klinisk signifikant ustabil medicinsk tilstand under behandling, som efter Investigators vurdering kan have, kan begrænse fortolkningen af resultaterne.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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ASD emner
Cirka to hundrede (200) mandlige og kvindelige forsøgspersoner af enhver etnisk baggrund i alderen 2-20 år set på Brain Treatment Center (BTC) mellem 2010 og 2015.
|
Der vil ikke være indgreb.
Dette er en diagramgennemgang.
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Sund kontrol
Tyve (20) mandlige og kvindelige forsøgspersoner af enhver etnisk baggrund i alderen 2-20 år med 'neurotypiske' EEG'er vil blive udvalgt til sammenligning med ASD-gruppen
|
Der vil ikke være indgreb.
Dette er en diagramgennemgang.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Childhood Autism Rating Scale (CARS)
Tidsramme: Baseline gennem afsluttet studie, et gennemsnit på 36 måneder
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Symptomreduktion i ASD vil blive målt ved at bruge reduktionen i CARS mellem to tidspunkter: Baseline (BL) CARS og Final CARS Evaluation.
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Baseline gennem afsluttet studie, et gennemsnit på 36 måneder
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Elektrofysiologisk
Tidsramme: Baseline gennem afsluttet studie, et gennemsnit på 36 måneder
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Ændringer i kvantitativt elektroencefalogram (qEEG) vil blive målt med vægt på de overordnede ændringer mellem to tidspunkter: BL EEG og Final EEG.
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Baseline gennem afsluttet studie, et gennemsnit på 36 måneder
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Keun-Young Kim, MD, Brain Treatment Center
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.
Generelle publikationer
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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. april 2016
Primær færdiggørelse (Faktiske)
1. april 2017
Studieafslutning (Faktiske)
1. april 2017
Datoer for studieregistrering
Først indsendt
15. april 2016
Først indsendt, der opfyldte QC-kriterier
29. april 2016
Først opslået (Skøn)
2. maj 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. maj 2017
Sidst verificeret
1. maj 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MeRT-016
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
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