Speed of Processing Training to Improve Cognition in Multiple Sclerosis

NCT ID: NCT02301260

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2020-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Speed of Processing Training (SPT)

SPT will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).

Group Type EXPERIMENTAL

Speed of Processing Training (SPT)

Intervention Type BEHAVIORAL

Placebo control group

Placebo control exercises will be administered on a laptop computer twice a week for 5 weeks (10 sessions)

Group Type PLACEBO_COMPARATOR

Placebo Control

Intervention Type BEHAVIORAL

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

Interventions

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Speed of Processing Training (SPT)

Intervention Type BEHAVIORAL

Placebo Control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Multiple Sclerosis Society

OTHER

Sponsor Role collaborator

Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Nancy Chiaravalloti

Director, Neuropsychology and Neuroscience Laboratory

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nancy Chiaravalloti, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

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Kessler Foundation

West Orange, New Jersey, United States

Site Status

Countries

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United States

References

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Goverover Y, Costa S, DeLuca J, Chiaravalloti N. The Efficacy of the Speed of Processing Training Program in Improving Functional Outcome: From Restoration to Generalization. Arch Phys Med Rehabil. 2023 Jun;104(6):925-931. doi: 10.1016/j.apmr.2023.01.017. Epub 2023 Feb 8.

Reference Type DERIVED
PMID: 36758712 (View on PubMed)

Other Identifiers

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RG 4997A5/1

Identifier Type: -

Identifier Source: org_study_id

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