Digital Cognition in Multiple Sclerosis (DigCog)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Multiple Sclerosis; Cognitive Decline

Treatments: Device: Tablet-based Game

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03569618

16-19891

Details and patient eligibility

About

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)

Full description

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).

Enrollment: 44 patients

Sex: All

Ages: 18 to 71 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

Game 1

Active Comparator group

Description:

Tablet-based Game 1.

Treatment:

Device: Tablet-based Game

Game 2

Placebo Comparator group

Description:

Tablet-based Game 2.

Treatment:

Device: Tablet-based Game