Speed of Processing Training to Improve Cognition in Multiple Sclerosis
19. februar 2020 opdateret af: Nancy Chiaravalloti, Kessler Foundation
Speed of Processing Training to Improve Cognition in Multiple Sclerosis: A Randomized Clinical Trial
The purpose of this research study is to investigate the effectiveness of a computerized technique designed to improve processing speed (i.e. the amount of time it takes for a person's brain to process information) in a multiple sclerosis (MS) population.
The study is designed to study how well this technique can help people with MS increase their processing speed and their ability to function better in everyday life.
This treatment protocol has been studied extensively with older adults, showing improvements on standard laboratory measures of processing speed and performance of activities of daily living.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is a double-blind, placebo-control randomized clinical trial examining the efficacy of Speed of Processing Training (SPT) for improving processing speed (PS) deficits in persons with Multiple Sclerosis (MS).
Slowed PS is one of the most common deficits in individuals with MS and such deficits have been shown to exert significant negative impact on multiple aspects of everyday life, including occupational and social functioning.
Despite these findings, few studies have attempted to remediate PS deficits in order to improve the everyday functioning of individuals with MS.
This study is designed to (1) apply a treatment protocol for PS impairments well-validated in an aging population to individuals with MS with objectively observable deficits in PS and document its efficacy on standard neuropsychological outcome measures.
In addition, the investigators will (2) assess the effectiveness of the intervention utilizing global measures of everyday life, including an objective measure (the Timed Activities of Daily Living; TIADL), as well as additional questionnaires to be completed by both the participant and a significant other.
This study is also designed to (3) examine the influence of degree of PS impairment on treatment efficacy using neuropsychological tests, (4) evaluate the long-term effects of the treatment protocol and (5) examine the utility of booster sessions to facilitate long-term treatment effects.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New Jersey
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West Orange, New Jersey, Forenede Stater, 07052
- Kessler Foundation
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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
18 år til 59 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- English as a primary language
- diagnosis of Multiple Sclerosis
- processing speed impairment (based on evaluation)
Exclusion Criteria:
- most recent exacerbation within one month
- currently taking steroids or benzodiazepines
- history of significant psychiatric illness (bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder
- significant alcohol or drug abuse history
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Speed of Processing Training (SPT)
SPT will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
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Placebo komparator: Placebo control group
Placebo control exercises will be administered on a laptop computer twice a week for 5 weeks (10 sessions)
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Placebo control exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in scores on standardized tests of processing speed
Tidsramme: Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
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Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in scores on self-report of emotional functioning, measured via questionnaire
Tidsramme: Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
|
Self-report questionnaires and objective measures of everyday performance will be used to determine whether there have been changes across the three time points.
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Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
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Change in scores on self-report of everyday functioning, measured via questionnaire
Tidsramme: Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed
|
Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed
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Change in scores on self-report of quality of life, measured via questionnaire
Tidsramme: Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
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Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Nancy Chiaravalloti, PhD, Kessler Foundation
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 2014
Primær færdiggørelse (Faktiske)
1. februar 2020
Studieafslutning (Faktiske)
1. februar 2020
Datoer for studieregistrering
Først indsendt
23. april 2014
Først indsendt, der opfyldte QC-kriterier
21. november 2014
Først opslået (Skøn)
25. november 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. februar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. februar 2020
Sidst verificeret
1. februar 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RG 4997A5/1
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 .