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

NCT ID: NCT02141022

Last Updated: 2016-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-09-30

Brief Summary

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.

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.

Conditions

Multiple Sclerosis; Cognitive Deficits; Gilenya Modifying Therapy for MS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

plasticity-based computerized cognitive remediation program

Intervention Type: OTHER

Gileyna

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Gileyna

Intervention Type: DRUG

Interventions

plasticity-based computerized cognitive remediation program

Intervention Type: OTHER

Gileyna

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Lauren Krupp

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lauren Krupp, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook University

Stony Brook, New York, United States

Countries

United States

Other Identifiers

IIRP-1450

Identifier Type: -

Identifier Source: secondary_id

CFTY720DUS26T

Identifier Type: -

Identifier Source: org_study_id