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| ID | Type | Description | Link |
|---|---|---|---|
| IIRP-1450 |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| plasticity-based computerized cognitive remediation program | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Neuropsychological Test Results at 12weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Krupp, M.D. | Stony Brook University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University | Stony Brook | New York | 11794 | United States |
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| Gileyna |
| Drug |
|
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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