- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03723356
Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis (MS)
24. mars 2021 oppdatert av: NYU Langone Health
Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis
Multiple sclerosis (MS) is the most common progressive neurologic disorder to occur in adults of working-age.
Despite longstanding recognition of cognitive impairment as a symptom of MS, two obstacles in measurement have limited understanding its biological basis, and therefore identifying targeted options for management.
First is the absence of a sensitive and precise measure of cognitive impairment.
Second is the absence of an index of disease status linked to brain pathophysiology and cognitive performance.
This project overcomes both obstacles to link cognitive impairment to MS disease biomarkers.
The absence of a sensitive and precise measure of cognitive impairment, along with the absence of an index of disease status linked to brain pathophysiology and cognitive performance, limits the understanding of the biological basis for multiple sclerosis (MS).
This project overcomes both obstacles to link cognitive function to MS disease biomarkers, and provides preliminary evaluation of a disease modifying therapy (Tecfidera) for preserving cognitive function.
Studieoversikt
Status
Avsluttet
Studietype
Observasjonsmessig
Registrering (Faktiske)
6
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10016
- New York University School of Medicine
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 45 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
20 MS participants and 10 healthy controls.
However, the data analysis is planned for 15 MS participants and 10 healthy control participants.
It is expected that 15 MS subjects and 10 healthy controls will complete 12 months.
Beskrivelse
Inclusion Criteria:
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- Male and Female subjects between 18 and 45 years
- WRAT-4 Reading [127] standard score > 85
- Able to undergo neuroimaging data collection procedures. For MS Participants
- Definite diagnosis of RRMS [128]
- EDSS of 0 to 6.0
- Adequate vision as as reported by the participant (with correction if applicable)
- Clinically prescribed Tecfidera, Tysabri or Ocrevus therapy by treating neurologist, with first dose being within 3 months + 14 days from baseline visit
- At baseline visit, concurrent medications to be kept constant over three months prior to data collection visits
- No relapse or steroids in previous month
Exclusion Criteria:
- Unable or unwilling to provide informed consent.
- Beck Depression Inventory-Fast Screen (BDI-FS) [129, 130] score of 4 or more
- Current alcohol or other substance use disorder
- Primary psychiatric disorder that would adversely influence ability to participate
- Other neurological condition associated with cognitive impairment (e.g., epilepsy, brain injury)
- Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction)
- Learned English language after 12 years of age
For low absolute low lymphocyte count (ALC), USPI guidance will be utilized.
For MS participants:
- Lemtrada, Cladribine, Mitoxantrone
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
MS Patients
Definite diagnosis of RRMS
|
5mCi of the radiotracer FDG administered intravenously as a bolus over 30s.
After injection, emission data will be collected for 60 min,
High-resolution T1-weighted structural image will be acquired using an MP2RAGE sequence.
Subject will beasked to look at the cross hair on a screen andnot fixate on any one thought.
DSI allows for more accurate characterization of diffusion,overcomes traditional dMRI artifacts, and is capable of more precise and detailedcharacterization of white matter fibers
|
Healthy Controls
gender aged match healthy
|
5mCi of the radiotracer FDG administered intravenously as a bolus over 30s.
After injection, emission data will be collected for 60 min,
High-resolution T1-weighted structural image will be acquired using an MP2RAGE sequence.
Subject will beasked to look at the cross hair on a screen andnot fixate on any one thought.
DSI allows for more accurate characterization of diffusion,overcomes traditional dMRI artifacts, and is capable of more precise and detailedcharacterization of white matter fibers
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
Tidsramme: Baseline
|
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
|
Baseline
|
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
Tidsramme: 3 Months
|
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
|
3 Months
|
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
Tidsramme: 6 Months
|
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
|
6 Months
|
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
Tidsramme: 9 Months
|
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
|
9 Months
|
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
Tidsramme: 12 Months
|
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
|
12 Months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Leigh Charvet, NYU Langone Health
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juli 2018
Primær fullføring (Faktiske)
9. januar 2021
Studiet fullført (Faktiske)
9. januar 2021
Datoer for studieregistrering
Først innsendt
27. september 2018
Først innsendt som oppfylte QC-kriteriene
25. oktober 2018
Først lagt ut (Faktiske)
29. oktober 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. mars 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. mars 2021
Sist bekreftet
1. mars 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 17-00238
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD-delingstidsramme
Beginning 3 months and ending 5 years following article publication.
Tilgangskriterier for IPD-deling
Researchers who provide a methodologically sound proposal.
IPD-deling Støtteinformasjonstype
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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