Computerized Exercise Training for Cognitive Remediation in Adults With Multiple Sclerosis Treated With Gilenya
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cognitive Studies, Cognitive Studies, Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | August 2013 |
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.
cognitive remediation in patients with Multiple Sclerosis (MS) who are beginning the disease
modifying pharmacotherapy Gileyna.
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.
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.
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
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