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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

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

    • New Jersey
      • West Orange, New Jersey, Forente stater, 07052
        • Kessler Foundation

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).
Placebo komparator: Placebo control group
Placebo control exercises will be administered on a laptop computer twice a week for 5 weeks (10 sessions)
Placebo control exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).

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
Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed

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
Self-report questionnaires and objective measures of everyday performance will be used to determine whether there have been changes across the three time points.
Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
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
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
Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

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

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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