Speed of Processing Training to Improve Cognition in Multiple Sclerosis
19 février 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
100
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New Jersey
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West Orange, New Jersey, États-Unis, 07052
- Kessler Foundation
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 59 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur placebo: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Change in scores on standardized tests of processing speed
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in scores on self-report of emotional functioning, measured via questionnaire
Délai: 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
Délai: Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed
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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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Nancy Chiaravalloti, PhD, Kessler Foundation
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2014
Achèvement primaire (Réel)
1 février 2020
Achèvement de l'étude (Réel)
1 février 2020
Dates d'inscription aux études
Première soumission
23 avril 2014
Première soumission répondant aux critères de contrôle qualité
21 novembre 2014
Première publication (Estimation)
25 novembre 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 février 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 février 2020
Dernière vérification
1 février 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RG 4997A5/1
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