Computerized Exercise Training for Cognitive Remediation in Adults With Multiple Sclerosis Treated With Gilenya

May 8, 2016 updated by: Lauren Krupp, Stony Brook University

A Pilot Study of Plasticity-Based and Adaptive Cognitive Remediation in Adults With Multiple Sclerosis Treated With Gilenya

This study is investigating the efficacy of computer-based cognitive exercises as a means of cognitive remediation in patients with Multiple Sclerosis (MS) who are beginning the disease modifying pharmacotherapy Gileyna.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gilenya represents the most recent advance in MS disease-modification therapy (DMT) and shows promise for neuroprotection, a feature relevant to the progressive neurologic damage associated with the disease. Cognitive impairment accompanies MS in 40-60% of cases and when present, additional symptomatic treatment combined with DMT is required. To date no symptomatic pharmacologic therapy has shown a consistent benefit on MS associated cognitive dysfunction. However, non-pharmacologic approaches show promise. With recent technical and scientific advances, cognitive training is rapidly evolving to become the most effective intervention for the cognitive impairments associated with a wide range of neurological conditions. However, these training programs have not yet been studied in MS.

This study will be a randomized open-label clinical pilot trial to compare a plasticity-based and adaptive cognitive remediation (PACR) program to an active control (ordinary computer games) in 20 adults with multiple sclerosis (MS) starting Gilenya therapy. Primary outcome measures will be used as preliminary indicators of effect, with improvements on program task-related measures and changes in cognitive measures. Secondary outcome measures will determine the feasibility of the use of these programs in patients with MS, as indicated by compliance and patient-reported experience.

Study Type

Interventional

Enrollment (Actual)

20

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
  • Relapsing Remitting MS Diagnosis [81]
  • Initiating Gilenya therapy, or current Gilenya therapy (kept constant for the past one month)
  • 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.

Exclusion Criteria:

  • Previous trial of Gilenya therapy
  • History of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment
  • Primary psychiatric disorder or unstable medical disorder that would influence ability to participate
  • History of computer-based training with procedures similar to those proposed
  • Learned English language after 12 years of age
  • Unable to comply with study procedures

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PACR Program: Plasticity based, Adaptive Cognitve Remediation
PACR Program Use: To use PACR, the participant navigates to the PACR study web site. The participant then logs into the PACR (using a study provided screen name and study identification number). A game-like experience begins, where the participant is presented with games in a set order. Each game consists of targeted exercises that contain the core science stimuli and tasks. The scheduling mechanism ensures that a participant progresses through the exercises in a defined order, generally moving from more simple (early sensory processing) exercises to more complex (multimodal, cognitive control) exercises over the course of the three-month experience.
Other: plasticity-based computerized cognitive remediation program
Drug: Gileyna
Active Comparator: Ordinary Computer Games
Active Control Program Use (Ordinary Computer Games): The active control program is composed of 13 ordinary computer games matched to the PACR condition overall. This condition is designed to be a face-valid approach to cognitive remediation. The control condition is also designed to account for nonspecific treatment effects, including placebo response, interactions with research personnel, and experience with computers and computer-related activities, and any halo or expectation effect on study assessments.
Drug: Gileyna

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Neuropsychological Test Results at 12weeks
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the feasibility of PACR for adults with MS on Gilenya therapy who have cognitive impairment based on Participant Adherence to Study Protocol
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

Novartis

Investigators

  • Principal Investigator: Lauren Krupp, M.D., Stony Brook University

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

August 1, 2013

Primary Completion (Actual)

September 1, 2014

Study 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 16, 2014

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 8, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTY720DUS26T
  • IIRP-1450

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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