Regional Cortical Cerebral Quantitative MRI Perfusion Correlation Neurocognition in Multiple Sclerosis
16. november 2015 opdateret af: Dr. Richard Aviv, Sunnybrook Health Sciences Centre
Multiple Sclerosis (MS) is a common disease affecting 1/1000 Canadians.
Cognition impairment is reported in 40-65% of patients and is socially and functionally disabling.
Although multiple sclerosis is widely regarded as a white matter disease, cortical disease burden is increasingly emphasized.
Studies confirm that gray matter (GM) disease is grossly underestimated by conventional MRI.
Although the cause for MS is unknown vascular impairment is implicated in nerve cell death.
Several studies have shown perfusion abnormalities in the central GM and white matter (WM) structure.
Severity of perfusion reduction correlates with lesion load, atrophy, MS subtype and disease duration.
Further extent of cortical atrophy correlates with neurocognitive impairment.
We hypothesize that cortical perfusion is a marker of cortical disease severity and correlates with neurocognitive impairment.
To show this we will measure regional cortical perfusion and regional brain and WM lesion volumes in 26 predefined brain regions using a template developed for Alzheimer's disease.
Regional perfusion will be correlated with neurocognitive tests validated for MS use.
Patients will be divided into impaired and non impaired and perfusion compared controlling for known confounding factors.
If confirmed cortical perfusion may be utilized as a surrogate marker of cognitive outcome in therapeutic studies.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
We hypothesize that cortical perfusion is a marker of cortical disease severity and correlates with neurocognitive impairment.
To show this we will measure regional cortical perfusion and regional brain and WM lesion volumes in 26 predefined brain regions using a template developed for Alzheimer's disease.
Regional perfusion will be correlated with neurocognitive tests validated for MS use.
Patients will be divided into impaired and non impaired and perfusion compared controlling for known confounding factors.
If confirmed cortical perfusion may be utilized as a surrogate marker of cognitive outcome in therapeutic studies.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
60
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
16 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Secondary progressive Multiple sclerosis
Beskrivelse
Inclusion Criteria:
- established SPMS according to the McDonald criteria
Exclusion Criteria:
- Patients with a history of drug/alcohol abuse, a premorbid (pre MS) psychiatric history, a head injury with loss of consciousness and a concurrent physical disease requiring medical attention (eg. cardiovascular disease etc), MRI contraindication including implants, pacemaker, aneurysm clips and known renal impairment
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Cognitive Impairment
Tidsramme: Cognitive impairment is assessed on the same day as the MRI scan
|
Cognitive impairment is assessed on the same day as the MRI scan
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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. december 2008
Primær færdiggørelse (Faktiske)
1. juni 2009
Studieafslutning (Faktiske)
1. november 2015
Datoer for studieregistrering
Først indsendt
19. december 2008
Først indsendt, der opfyldte QC-kriterier
19. december 2008
Først opslået (Skøn)
22. december 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. november 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. november 2015
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 373-2007
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 .
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Baskent UniversityIkke rekrutterer endnuMULTIPL SKLEROSETyrkiet (Türkiye)
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