- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03841903
Spinal Cord Analysis in Multiple Sclerosis
Structural Analysis of Spinal Cord Grey and White Matter Changes in Patients With Multiple Sclerosis: Sub-study Within the Swiss Multiple Sclerosis Cohort (SMSC-study)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The Swiss Multiple Sclerosis Cohort (SMSC-Study) aims to better evaluate specific Multiple Sclerosis (MS) phenotypes through the systematic and standardised documentation and acquisition of clinical course and paraclinical tests such as magnetic resonance imaging (MRI), blood and cerebrospinal fluid (CSF) specimens.
Determination of the relative contribution of SC metrics (cervical cord volume, cervical grey matter (GM) cord volume, cervical white matter (WM) cord volume, SC lesion load) to disability in MS.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Basel, Sveits, 4031
- Dep. of Neurology, University Hospital Basel
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion criteria
- Diagnosis of multiple sclerosis
- Steroid free period: > 4 weeks
- healthy controls without any history of severe neurological, internistic or psychiatric disease
Exclusion Criteria for all participants:
- History of severe (other) neurological, internistic or psychiatric disease
MRI related exclusion criteria:
- Paramagnetic and/or superparamagnetic foreign objects in the body
- Pacemaker
- Claustrophobia
- Pregnancy, lactation
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
relapsing-remitting MS undergoing spinal cord MRI
|
high-resolution spinal cord MRI sequences on a 3Tesla magnet (Siemens Prisma) with high contrast between SC and CSF as well as high contrast within the SC (grey-white matter contrast)
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secondary progressive MS undergoing spinal cord MRI
|
high-resolution spinal cord MRI sequences on a 3Tesla magnet (Siemens Prisma) with high contrast between SC and CSF as well as high contrast within the SC (grey-white matter contrast)
|
primary progressive MS undergoing spinal cord MRI
|
high-resolution spinal cord MRI sequences on a 3Tesla magnet (Siemens Prisma) with high contrast between SC and CSF as well as high contrast within the SC (grey-white matter contrast)
|
healthy control (HC) undergoing spinal cord MRI
|
high-resolution spinal cord MRI sequences on a 3Tesla magnet (Siemens Prisma) with high contrast between SC and CSF as well as high contrast within the SC (grey-white matter contrast)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in SC atrophy assessed by MRI
Tidsramme: at baseline and after 1 year
|
Determination of the degree of SC grey and white matter atrophy in MS patients with relapsing versus progressive disease courses in comparison to matched HC.
Measurement tool is a structural MRI of the brain and spinal cord at 3 Tesla.
Assessment will last approx.
90 minutes.
|
at baseline and after 1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Timed 25-foot walk test (T25-FW)
Tidsramme: at baseline and after 1 year and after 5 years
|
Quantitative mobility and leg function performance test ( in MS patients) based on a timed 25-walk.
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely.
The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark.
|
at baseline and after 1 year and after 5 years
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Change in Multiple Sclerosis Walking Scale-12 (MSWS-12) Questionnaire
Tidsramme: at baseline and after 1 year and after 5 years
|
Self-assessment scale which measures the impact of MS on walking.
It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks.
Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation.
|
at baseline and after 1 year and after 5 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Ludwig Kappos, Prof. Dr. MD, Department of Neurology University Hospital Basel
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2016-01461; me16Kappos2
Legemiddel- og utstyrsinformasjon, studiedokumenter
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