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Speed of Processing Training to Improve Cognition in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speed of Processing Training (SPT)
Placebo Control
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Processing Speed, Intervention, Multiple Sclerosis, Cognition

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Speed of Processing Training (SPT)

Placebo control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in scores on standardized tests of processing speed

Secondary Outcome Measures

Change in scores on self-report of emotional functioning, measured via questionnaire
Self-report questionnaires and objective measures of everyday performance will be used to determine whether there have been changes across the three time points.
Change in scores on self-report of everyday functioning, measured via questionnaire
Change in scores on self-report of quality of life, measured via questionnaire

Full Information

First Posted
April 23, 2014
Last Updated
February 19, 2020
Sponsor
Kessler Foundation
Collaborators
National Multiple Sclerosis Society
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1. Study Identification

Unique Protocol Identification Number
NCT02301260
Brief Title
Speed of Processing Training to Improve Cognition in Multiple Sclerosis
Official Title
Speed of Processing Training to Improve Cognition in Multiple Sclerosis: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
Collaborators
National Multiple Sclerosis Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Processing Speed, Intervention, Multiple Sclerosis, Cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Speed of Processing Training (SPT)
Arm Type
Experimental
Arm Description
SPT will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Arm Title
Placebo control group
Arm Type
Placebo Comparator
Arm Description
Placebo control exercises will be administered on a laptop computer twice a week for 5 weeks (10 sessions)
Intervention Type
Behavioral
Intervention Name(s)
Speed of Processing Training (SPT)
Intervention Type
Behavioral
Intervention Name(s)
Placebo Control
Intervention Description
Placebo control exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Primary Outcome Measure Information:
Title
Change in scores on standardized tests of processing speed
Time Frame
Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
Secondary Outcome Measure Information:
Title
Change in scores on self-report of emotional functioning, measured via questionnaire
Description
Self-report questionnaires and objective measures of everyday performance will be used to determine whether there have been changes across the three time points.
Time Frame
Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
Title
Change in scores on self-report of everyday functioning, measured via questionnaire
Time Frame
Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed
Title
Change in scores on self-report of quality of life, measured via questionnaire
Time Frame
Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Chiaravalloti, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Speed of Processing Training to Improve Cognition in Multiple Sclerosis

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