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

NCT02141022 | Completed

• 2 other identifiers: CFTY720DUS26TIIRP-1450
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Cognitive Deficits; Gilenya Modifying Therapy for MS

Keywords

Multiple Sclerosis; Cognition; Cognitive Remediation; Gilenya; Computerized Cognitive Exercise

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Neuropsychological Test Results at 12weeks

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Study Arms (2)

PACR Program: Plasticity based, Adaptive Cognitve Remediation

EXPERIMENTAL

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

Ordinary Computer Games

ACTIVE COMPARATOR

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

Interventions

plasticity-based computerized cognitive remediation program OTHER

PACR Program: Plasticity based, Adaptive Cognitve Remediation

Gileyna DRUG

Ordinary Computer Games; PACR Program: Plasticity based, Adaptive Cognitve Remediation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead
• Novartis: collaborator

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Cognition Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lauren Krupp, M.D.

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: May 16, 2014
• Study Start: August 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: May 10, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)