Speed of Processing Training to Improve Cognition in Multiple Sclerosis

Sponsor

Kessler Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT02301260

Collaborator

National Multiple Sclerosis Society (Other)

100

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Behavioral: Speed of Processing Training (SPT) Behavioral: Placebo Control	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Speed of Processing Training to Improve Cognition in Multiple Sclerosis: A Randomized Clinical Trial

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Feb 1, 2020

Actual Study Completion Date :

Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Speed of Processing Training (SPT) SPT will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).	Behavioral: Speed of Processing Training (SPT)
Placebo Comparator: Placebo control group Placebo control exercises will be administered on a laptop computer twice a week for 5 weeks (10 sessions)	Behavioral: Placebo Control Placebo control exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).

Arm

Intervention/Treatment

Experimental: Speed of Processing Training (SPT)

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

Behavioral: Speed of Processing Training (SPT)

Placebo Comparator: Placebo control group

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

Behavioral: Placebo Control

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

Outcome Measures

Primary Outcome Measures

Change in scores on standardized tests of processing speed [Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed]

Secondary Outcome Measures

Change in scores on self-report of emotional functioning, measured via questionnaire [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.
Change in scores on self-report of everyday functioning, measured via questionnaire [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 [Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts 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