Digital Cognition in Multiple Sclerosis
| Status: | Completed |
|---|---|
| Conditions: | Cognitive Studies, Cognitive Studies, Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 3/7/2019 |
| Start Date: | April 1, 2018 |
| End Date: | January 15, 2019 |
Effect of a Digital Therapeutic on Processing Speed in Adults With Multiple Sclerosis
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)
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)
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).
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).
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.
We found this trial at
1
site
San Francisco, California 94143
Principal Investigator: Riley Bove, MD
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