Speed of Processing Training to Improve Cognition in Multiple Sclerosis
19 februari 2020 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
100
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
New Jersey
-
West Orange, New Jersey, Verenigde Staten, 07052
- Kessler Foundation
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 59 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Speed of Processing Training (SPT)
SPT will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
|
|
|
Placebo-vergelijker: 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).
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change in scores on standardized tests of processing speed
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in scores on self-report of emotional functioning, measured via questionnaire
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Nancy Chiaravalloti, PhD, Kessler Foundation
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2014
Primaire voltooiing (Werkelijk)
1 februari 2020
Studie voltooiing (Werkelijk)
1 februari 2020
Studieregistratiedata
Eerst ingediend
23 april 2014
Eerst ingediend dat voldeed aan de QC-criteria
21 november 2014
Eerst geplaatst (Schatting)
25 november 2014
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 februari 2020
Laatste update ingediend die voldeed aan QC-criteria
19 februari 2020
Laatst geverifieerd
1 februari 2020
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- RG 4997A5/1
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .