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CompletedNCT02301260Updated Feb 20, 2020

Speed of Processing Training to Improve Cognition in Multiple Sclerosis

An interventional study of Speed of Processing Training (SPT) and Placebo Control in Multiple Sclerosis, sponsored by Kessler Foundation. Completed at 1 site in United States. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2020-02-20.

Sponsored by Kessler Foundation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • Processing Speed
  • Intervention
  • Multiple Sclerosis
  • Cognition
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 100 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Kessler Foundation is the lead sponsor of 170 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • English as a primary language
  • diagnosis of Multiple Sclerosis
  • processing speed impairment (based on evaluation)

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralSpeed of Processing Training (SPT)
  • BehavioralPlacebo Control

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

06

What researchers measure

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

    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

  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

07

Study locations

1 site
  • Kessler Foundation
    West Orange, New Jersey 07052, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02301260
Lead sponsor
Kessler Foundation
Collaborators
National Multiple Sclerosis Society
Responsible party
Nancy Chiaravalloti (Director, Neuropsychology and Neuroscience Laboratory, Kessler Foundation) — Principal investigator
First posted
Nov 25, 2014
Start date
Apr 2014
Primary completion
Feb 2020
Completion
Feb 2020
Last update
Feb 20, 2020

Study contacts

Nancy Chiaravalloti, PhD
principal investigator · Kessler Foundation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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