NCT02301260

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

5.8 years

First QC Date

April 23, 2014

Last Update Submit

February 19, 2020

Conditions

Multiple Sclerosis

Keywords

Processing SpeedInterventionMultiple SclerosisCognition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • 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

Study Arms (2)

Speed of Processing Training (SPT)

EXPERIMENTAL

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

Behavioral: Speed of Processing Training (SPT)

Placebo control group

PLACEBO COMPARATOR

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

Behavioral: Placebo Control

Interventions

Speed of Processing Training (SPT)BEHAVIORAL
Speed of Processing Training (SPT)
Placebo ControlBEHAVIORAL

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

Placebo control group

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Related Publications (1)

  • 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.

    PMID: 36758712DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nancy Chiaravalloti, PhD

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Neuropsychology and Neuroscience Laboratory

Study Record Dates

First Submitted

April 23, 2014

First Posted

November 25, 2014

Study Start

April 1, 2014

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

US(1)