Intellectual Enrichment to Build Cognitive Reserve in MS

Study Overview
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Brief Summary
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Cognitive problems are a primary concern for people with multiple sclerosis. In many cases, people with MS report these issues to be more debilitating than the motor symptoms that are targeted by most treatment strategies. For people with MS, impaired memory and thinking skills can interfere with the ability to function efficiently in multiple professional and personal roles. Finding ways to decrease, slow, or reverse declines in memory and thinking skills is a vitally important research priority. We now know that engaging in intellectually enriching activities helps protect against the negative impact of MS disease-related declines in memory and thinking. Such activities contribute to something called 'cognitive reserve,' which serves as a protection against disease-related declines in memory and thinking. Thus far, no one has created a treatment that aims to provide a concentrated 'dose' of intellectual enrichment to build cognitive reserve. The present intervention aims to do precisely this. Here, we have developed a program of enriching activities that are delivered via a personal iPad. This allows for a 12-week 'treatment' that is entirely home-based, while also providing close personal contact between participants and our study personnel, who will communicate daily via emails. Week by week, participants choose from a menu of intellectually enriching activities such that their treatment is dynamic and customizable to fit their interests. The intervention is designed to be fun, as we hope the activities will be incorporated into people's lives beyond the period of the study itself. Given what we already know about the striking benefits of cognitive reserve to protect against disease-related declines in cognitive functioning, we expect to show that treatment with a daily, intense, intellectually enriching schedule of activities results in improved thinking and memory for people with MS. We will also investigate the positive impact of our treatment on the brains of people with MS through brain scans. We expect to see evidence for a shift toward more efficient processing in the brain, changes that translate to improved memory and thinking skills.

Official Title
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A Randomized Controlled Trial of Intellectual Enrichment to Build Cognitive Reserve in Multiple Sclerosis

Conditions
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Cognitive Impairment in Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Intellectual Enrichment daily activities
* Behavioral: Intellectual Enrichment documentary videos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 25-65 MS duration >5 years read and speak English fluently Exclusion Criteria: currently experiencing an MS exacerbation MS exacerbation within 6 weeks of study start left handed non-MRI compatible: metal in body, claustrophobic history of neurological disorder other than MS history of head injury history of schizophrenia or bipolar disorder pregnant currently taking steroids, benzodiazepines, and/or neuroleptics do not speak English as primary language

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Documentary videos<br>In the placebo control condition, participants watch daily videos. | Behavioral: Intellectual Enrichment documentary videos<br>* Participants watch daily documentary videos.<br>* Other names: Placebo control condition;|
| Experimental: Intellectual Enrichment<br>Daily activities that encourage intellectual enrichment, including games, reading/writing, and hobby activities. | Behavioral: Intellectual Enrichment daily activities<br>* A daily program of intellectually enriching, iPad/tablet-based activities: games, reading/writing, hobby activities, or a documentary video (control).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Hopkins Verbal Learning Test and Brief Visuospatial Memory Test, Total Learning and Delayed Recall |  | Baseline and 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Beck Depression Inventory |  | Baseline and 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive reserve, intellectual enrichment