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

CompletedNot a drug-phase studyRelapsing MSNCT02141022

What it found

No results found

We found no results in the registry or in papers.

This trial finished 12 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • plasticity-based computerized cognitive remediation program

Given to everyone in the trial

  • Gileyna

What it measured

Main measures

  • Change from Baseline in Neuropsychological Test Results at 12weeks

    12 weeks

Other measures (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

    Thinking and memoryQuality of life (reported by participants)Feasibility

Who could take part

Relapsing MS · 18 to 70

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

    Loading reviews and guidelines…

    History

      1. Started

        Aug 2013

      2. Main results due

        Sept 2014

      3. Finished

        Sept 2015

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