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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02141022
• Other study ID #: CFTY720DUS26T
• Secondary ID: IIRP-1450
• Status: Active, not recruiting
• Phase: N/A
• First received: February 14, 2014
• Last updated: November 18, 2015
• Start date: August 2013

Study information

• Verified date: November 2015
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Deficits
• Gilenya Modifying Therapy for MS
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• plasticity-based computerized cognitive remediation program

Drug:
• Gileyna

Locations

Country	Name	City	State
United States	Stony Brook University	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Neuropsychological Test Results at 12weeks		12 weeks	No
Secondary	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	No