- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03723356
Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis (MS)
24 mars 2021 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
6
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
New York
-
New York, New York, Förenta staterna, 10016
- New York University School of Medicine
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 45 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Leigh Charvet, NYU Langone Health
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juli 2018
Primärt slutförande (Faktisk)
9 januari 2021
Avslutad studie (Faktisk)
9 januari 2021
Studieregistreringsdatum
Först inskickad
27 september 2018
Först inskickad som uppfyllde QC-kriterierna
25 oktober 2018
Första postat (Faktisk)
29 oktober 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 mars 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 mars 2021
Senast verifierad
1 mars 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 17-00238
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Tidsram för IPD-delning
Beginning 3 months and ending 5 years following article publication.
Kriterier för IPD Sharing Access
Researchers who provide a methodologically sound proposal.
IPD-delning som stöder informationstyp
- SAV
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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