Computerized Cognitive Exercise Training Treatment for Adults With Multiple Sclerosis

Study Overview
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Brief Summary
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Cognitive impairment remains a major disability for individuals with multiple sclerosis (MS). The primary objective of this study is to evaluate the efficacy for treating MS-associated cognitive deficits using a unique computer-based plasticity-based and adaptive cognitive remediation treatment (PACR) compared to a computer-based control. This novel cognitive remediation approach has led to striking improvements in cognitive functioning in other disorders (schizophrenia, traumatic brain injury, aging, and dementia) but has never been applied to individuals with MS. The investigators will enroll 136 MS participants who will be randomized in a 2:1 pattern to complete either the treatment or control condition for 60 hours across a 12-week treatment period. Both the treatment and control conditions will be accessed remotely by the subjects from a study-provided laptop computer. Study outcomes will include program compliance, performance on study tasks and neuropsychological measures, quality of life and functional status. Given the success of this program with other disorders and strong preliminary data from our feasibility study, the investigators believe PACR is an exciting untapped opportunity to improve cognition in individuals with MS.

Official Title
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Plasticity-based, Adaptive, Computerized Cognitive Remediation Treatment (PACR) for Adults With Multiple Sclerosis (MS)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-70 Definite MS Diagnosis, any subtype [83] Probable cognitive impairment as defined by a score ≤ 1 SD below the mean of normative data on the SDMT Concurrent medications to be kept constant over three months (as possible) 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 Willing to sign Agreement to Borrow Laptop Exclusion Criteria: History of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment Primary psychiatric disorder that would influence ability to participate Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction) Alcohol or other substance use disorder History of computer-based training manufactured by Posit Science Learned English language after 12 years of age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>plasticity-based, adaptive, computerized cognitive remediation (PACR) | Other: PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)<br> <br> |
| Active Comparator: Treatment B<br>Ordinary Computer Games (an active control condition) | Other: PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite derived from a standardized battery of neuropsychological tests | Covariates will include baseline cognitive status, PACR program compliance, PACR task improvement, and participant-reported outcomes | 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A timed measure based on direct observation of functional performance |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Cognitive remediation, Plasticity-based, adaptive, computerized cognitive remediation, Cognitive impairment