Digital Cognition in Multiple Sclerosis

Study Overview
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Brief Summary
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A DIGITAL THERAPEUTIC TO IMPROVE THINKING IN MULTIPLE SCLEROSIS WHO: 65 participants with a confirmed diagnosis of Multiple Sclerosis (MS) WHY: Purpose of the study is to compare the effect of 2 tablet-based brain training digital tools on important components of thinking (cognition). WHAT: Complete a set of tests (physical and cognitive) at baseline, 6 weeks and 14 weeks, and use one of two brain training tools on an iPad in your home, for 25 minutes a day, 5 days a week, for 6 weeks. WHERE: UCSF WEILL INSTITUTE FOR NEUROSCIENCES (675 Nelson Rising Lane, San Francisco, CA)

Detailed Description
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The purpose of this study is to begin to test a brain training video game in people with Multiple Sclerosis (MS). Visit 1. After informed consent, you will complete a series of questions about your functioning and mood. You will then complete a series of tests (vision, hand tapping, walking). Then, you will complete a set of thinking tests. The first set will be paper and pencil. The second set will be on a tablet or a computer. You will use your study code to sign into these tools and you won't provide any personal details for the digitized tests. Finally, you will complete the cognitive training tool. There are two versions of this digital, iPad based tool, which takes about 25 minutes to complete and is designed to be entertaining. You will be randomized into 1 of 2 groups: each group will play a version of the brain training game. You will not be told what group/game type you were randomized into. You will be given the tablet with the game on it to take home, and to practice this game 5 times a week for 6 weeks. Visit 2. After the 6 weeks of at-home training, you will then come back to the research study unit to do a repeat of the initial visit (with physical and cognitive assessments). At this study visit, you will also be returning the iPad. Visit 3. You will then return 8 weeks after Visit 2, to do a repeat of the assessments. You will be compensated for each study visit (visit 1: $50, visit 2: $100, visit 3: $150).

Official Title
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Effect of a Digital Therapeutic on Processing Speed in Adults With Multiple Sclerosis

Conditions
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Multiple Sclerosis, Cognitive Decline

Intervention / Treatment
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* Device: Tablet-based Game


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men or women diagnosed with multiple sclerosis (MS) or clinically isolated syndrome (CIS) SDMT z-score range (-2 to +1) Wifi available in home Able to use a tablet (iPad) Able to attend 3 study visits in person. Exclusion Criteria: Clinician's assessment of visual, cognitive, or motor impairment that would preclude participation. A clinical relapse within the last 30 days. Steroid treatment for clinical relapse within the last 30 days.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 71 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: Game 1<br>Tablet-based Game 1. | Device: Tablet-based Game<br>* Tablet-based game aimed at improving processing speed and attention.<br>|
| Placebo Comparator: Game 2<br>Tablet-based Game 2. | Device: Tablet-based Game<br>* Tablet-based game aimed at improving processing speed and attention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Processing Speed After 6 Weeks of Treatment With a Digital Therapeutic 'Game 1', vs. 'Game 2'. | Processing speed is being measured by the Symbol Digit Modalities Test (SDMT) score. SDMT measures the time to pair abstract symbols with specific numbers. The test requires visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items in 90 seconds. (max=110, min=0). Higher scores indicate improvement. Lower scores indicate worsening. | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With at Least 4-point Increase in SDMT Above Their Baseline Value 8 Weeks After Treatment | Number of participants showing a clinically meaningful 4+ point increase in SDMT (symbol digit modalities test) relative to baseline SDMT score. Comparison of SDMT changes 8 weeks after end of treatment with Tool 1 vs. Tool 2. | 14 weeks |