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Completed

NCT Number: NCT02301260

Speed of Processing Training to Improve Cognition in Multiple Sclerosis

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.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

West Orange, New Jersey, 07052, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Speed of Processing Training (SPT)

Behavioral

Placebo control

Behavioral

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

Primary outcomes

  1. 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 outcomes

  1. Change in scores on self-report of emotional functioning, measured via questionnaire

    Time frame: 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • National Multiple Sclerosis Society

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2014
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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