Computerized Cognitive Exercise Training Treatment for Adults With Multiple Sclerosis

November 18, 2015 updated by: Lauren Krupp, Stony Brook University

Plasticity-based, Adaptive, Computerized Cognitive Remediation Treatment (PACR) for Adults With Multiple Sclerosis (MS)

Cognitive impairment remains a major disability for individuals with multiple sclerosis (MS). The primary objective of this study is to evaluate the efficacy for treating MS-associated cognitive deficits using a unique computer-based plasticity-based and adaptive cognitive remediation treatment (PACR) compared to a computer-based control. This novel cognitive remediation approach has led to striking improvements in cognitive functioning in other disorders (schizophrenia, traumatic brain injury, aging, and dementia) but has never been applied to individuals with MS. The investigators will enroll 136 MS participants who will be randomized in a 2:1 pattern to complete either the treatment or control condition for 60 hours across a 12-week treatment period. Both the treatment and control conditions will be accessed remotely by the subjects from a study-provided laptop computer. Study outcomes will include program compliance, performance on study tasks and neuropsychological measures, quality of life and functional status. Given the success of this program with other disorders and strong preliminary data from our feasibility study, the investigators believe PACR is an exciting untapped opportunity to improve cognition in individuals with MS.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 18-70
  • Definite MS Diagnosis, any subtype [83]
  • Probable cognitive impairment as defined by a score ≤ 1 SD below the mean of normative data on the SDMT
  • Concurrent medications to be kept constant over three months (as possible)
  • No relapse or steroids in previous month
  • Reading score on WRAT-3 of 37 or greater
  • Visual, auditory and motor capacity to operate computer software, as judged by treating neurologist or study staff
  • Willing to sign Agreement to Borrow Laptop

Exclusion Criteria:

  • History of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment
  • Primary psychiatric disorder that would influence ability to participate
  • Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction)
  • Alcohol or other substance use disorder
  • History of computer-based training manufactured by Posit Science
  • Learned English language after 12 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A
plasticity-based, adaptive, computerized cognitive remediation (PACR)
Other: PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)
Active Comparator: Treatment B
Ordinary Computer Games (an "active control condition")
Other: PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A composite derived from a standardized battery of neuropsychological tests
Time Frame: 12weeks
Covariates will include baseline cognitive status, PACR program compliance, PACR task improvement, and participant-reported outcomes
12weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
A timed measure based on direct observation of functional performance
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Collaborators

National Multiple Sclerosis Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimate)

May 19, 2014

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 18, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG4808A81

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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