Multiple SclerosisDigCogNCT03569618
Digital Cognition in Multiple Sclerosis
A study testing Tablet-based Game in people with Multiple Sclerosis and Cognitive Decline, run by University of California, San Francisco at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Multiple Sclerosis, Cognitive Decline
- What is being tested?
- Tablet-based Game
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 15 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94158
About this study
Official title: 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)
Read the detailed 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).
- Conditions
- Multiple Sclerosis, Cognitive Decline
- Being tested
- Tablet-based Game
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet-based GameDevice
Tablet-based game aimed at improving processing speed and attention.
| Study group | Role | What they receive |
|---|---|---|
| Game 1 | Active comparator | Tablet-based Game 1. Receives: Device: Tablet-based Game |
| Game 2 | Placebo comparator | Tablet-based Game 2. Receives: Device: Tablet-based Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks
Secondary outcomes (1)
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.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Apr 2018
- Primary completion1 Nov 2018
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Akili Interactive Labs, Inc.
- Responsible party
- Sponsor
- Investigators
- Riley Bove, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569618
- Sponsor's protocol ID
- 16-19891
- Acronym
- DigCog
- Status last verified
- Oct 2020
- First submitted
- 13 Mar 2018
- Last updated
- 26 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bove R, Rowles W, Zhao C, Anderson A, Friedman S, Langdon D, Alexander A, Sacco S, Henry R, Gazzaley A, Feinstein A, Anguera JA. A novel in-home digital treatment to improve processing speed in people with multiple sclerosis: A pilot study. Mult Scler. 2021 Apr;27(5):778-789. doi: 10.1177/1352458520930371. Epub 2020 Jun 25.
PubMed 32584155Hsu WY, Rowles W, Anguera JA, Anderson A, Younger JW, Friedman S, Gazzaley A, Bove R. Assessing Cognitive Function in Multiple Sclerosis With Digital Tools: Observational Study. J Med Internet Res. 2021 Dec 30;23(12):e25748. doi: 10.2196/25748.
PubMed 34967751Hsu WY, Rowles W, Anguera JA, Zhao C, Anderson A, Alexander A, Sacco S, Henry R, Gazzaley A, Bove R. Application of an Adaptive, Digital, Game-Based Approach for Cognitive Assessment in Multiple Sclerosis: Observational Study. J Med Internet Res. 2021 Jan 20;23(1):e24356. doi: 10.2196/24356.
PubMed 33470940
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Digital Therapeutic on Processing Speed in Adults With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03569618
- Acronym / sponsor ID
- DigCog / 16-19891
- Conditions
- Multiple Sclerosis, Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Akili Interactive Labs, Inc.
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Posted 26 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Game 1 | Active comparator | Device: Tablet-based GameTablet-based Game 1. |
| Game 2 | Placebo comparator | Device: Tablet-based GameTablet-based Game 2. |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tablet-based GameTablet-based game aimed at improving processing speed and attention. | Device | Game 1, Game 2 |
Primary outcome
Change in Processing Speed After 6 Weeks of Treatment With a Digital Therapeutic 'Game 1', vs. 'Game 2'.
Time frame: Baseline and 6 weeks
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.
1 secondary outcome
Number of Participants With at Least 4-point Increase in SDMT Above Their Baseline Value 8 Weeks After Treatment
Time frame: 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32584155Bove R, Rowles W, Zhao C, Anderson A, Friedman S, Langdon D, Alexander A, Sacco S, Henry R, Gazzaley A, Feinstein A, Anguera JA. A novel in-home digital treatment to improve processing speed in people with multiple sclerosis: A pilot study. Mult Scler. 2021 Apr;27(5):778-789. doi: 10.1177/1352458520930371. Epub 2020 Jun 25.
- Derived from this study: PubMed 34967751Hsu WY, Rowles W, Anguera JA, Anderson A, Younger JW, Friedman S, Gazzaley A, Bove R. Assessing Cognitive Function in Multiple Sclerosis With Digital Tools: Observational Study. J Med Internet Res. 2021 Dec 30;23(12):e25748. doi: 10.2196/25748.
- Derived from this study: PubMed 33470940Hsu WY, Rowles W, Anguera JA, Zhao C, Anderson A, Alexander A, Sacco S, Henry R, Gazzaley A, Bove R. Application of an Adaptive, Digital, Game-Based Approach for Cognitive Assessment in Multiple Sclerosis: Observational Study. J Med Internet Res. 2021 Jan 20;23(1):e24356. doi: 10.2196/24356.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riley Bove, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet-based Game in people with Multiple Sclerosis and Cognitive Decline, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Processing Speed After 6 Weeks of Treatment With a Digital Therapeutic 'Game 1', vs. 'Game 2'. (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03569618, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.