- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02301260
Speed of Processing Training to Improve Cognition in Multiple Sclerosis
19. februar 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New Jersey
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West Orange, New Jersey, Forente stater, 07052
- Kessler Foundation
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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 59 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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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Hva måler studien?
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 |
Tiltaksbeskrivelse |
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
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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Nancy Chiaravalloti, PhD, Kessler Foundation
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
1. april 2014
Primær fullføring (Faktiske)
1. februar 2020
Studiet fullført (Faktiske)
1. februar 2020
Datoer for studieregistrering
Først innsendt
23. april 2014
Først innsendt som oppfylte QC-kriteriene
21. november 2014
Først lagt ut (Anslag)
25. november 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. februar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. februar 2020
Sist bekreftet
1. februar 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RG 4997A5/1
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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