Multiple SclerosisNCT03737825
Computerized Cognitive Training in MS
A study testing Computerized gaming rehabilitation Program 1 and Computerized gaming rehabilitation Program 2 in people with Multiple Sclerosis and Cognitive Decline, run by University of California, San Francisco at 2 sites in 2 countries.
Trial summary
WHO: 40 participants with a confirmed diagnosis of Multiple Sclerosis (MS) able to engage in moderate physical activity. WHY: The purpose of this study is to evaluate two computerized brain training tools, which include light physical activity, to see if they can help improve cognitive functions, such as memory and… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis, Cognitive Decline
- What is being tested?
- Computerized gaming rehabilitation Program 1 and Computerized gaming rehabilitation Program 2
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Apr 2019to 12 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years
- Presence of subjective cognitive complain from patient
- Objective general cognitive impairment: paper-and-pencil Symbol Digit Modalities Test (SDMT) z-score < -0.5 at screening
Who cannot join
- Falls in the past 12 weeks as evaluated in the enrollment interview [Hopkins Falls Grading Scale (Grade >1)]
- Strong risk of falling, assessed using the miniBEST (score< 16)
- Psychiatric co-morbidity or anti-depressive or anxiolytic medication that has been changed over the 6 months preceding consideration for study enrollment
- Colorblindness
- Presence of clinically and/or radiologically confirmed relapses or disease progression in the past 12 weeks.
- Visual, mental, motor or brainstem Functional Systems Score (FSS) on the Expanded Disability Status Scale (EDSS) superior to 2.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Weill Institute for Neurosciences, University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: Computerized Cognitive Training for Patients With Cognitive Deficits Due to Multiple Sclerosis: a Pilot Study
WHO: 40 participants with a confirmed diagnosis of Multiple Sclerosis (MS) able to engage in moderate physical activity.
WHY: The purpose of this study is to evaluate two computerized brain training tools, which include light physical activity, to see if they can help improve cognitive functions, such as memory and attention, for patients with MS.
Read more
WHAT: Complete a set of tests (physical and cognitive) at baseline, wear a Fitbit Flex device at home for the duration of the study, 3 supervised sessions for 4 weeks at UCSF, one visit for physical and cognitive tests at one week after the final supervised session, and one final visit 6 months after the final supervised session.
WHERE: 20 participants at the UCSF Weill Institute for Neurosciences (675 Nelson Rising Lane, San Francisco, CA); 20 participants at Lausanne University Hospital (Rue du Bugnon 46, 1005 Lausanne, Switzerland)
Read the detailed description
This is a dual-site trial with identical study activities taking place at both locations. If you live in/near San Francisco, study visits will take place at UCSF; if you live in/near Lausanne, Switzerland, study visits will take place at the Lausanne University Hospital.
You will be asked to attend one initial session for cognitive tests and answer questions regarding your medical history to see if you are eligible for the study. This process takes about 20 minutes. If you are eligible you will be asked to schedule the following appointments to participate:
First you will be randomized into one of two different training programs. You will not be able to choose which program you are placed in, but have equal chances of being randomized into each:
- Program 1 involves brain training games displayed on a large screen. Participants will use whole-body movements to complete game tasks. Tasks involve movements such as reaching, stepping, and jogging in place. These movements are tracked by a motion sensor. Stretching, warm-up, and cool down sessions will be mandated prior to and following the tasks.
- Program 2 involves brain training and guided, light physical exercise games on a tablet device. The exercise involves movements such as reaching, stepping, and stretching. Stretching, warm-up, and cool down sessions will be mandated prior to and following the tasks.
Baseline Visit: This session should take about two hours. You will be given some cognitive, visual and physical tests. You will be given questionnaires about your mood, fatigue and function. You will receive a Fitbit Flex to be worn daily for the duration of the study. The Fitbit will track daily active step count, number of active minutes, quality/length of sleep cycles.
Week 1-4 Visits (12 sessions in total): These sessions will be 1 hour and 30 minutes each (Note: the first session will be 2 hours to account for calibrations). You will come in three times a week for four weeks to attend on-site sessions. You will be asked to complete digital, cognitive and physical training at each one of these visits.
Post-Training Visit: You will be asked to come in for an assessment 1 week after completing your last training session. This visit will take about 2 hours. You will be asked to complete some cognitive, visual, and physical tests. You will be given questionnaires on mood, fatigue, and everyday function. You will also return the Fitbit you received at the start of the study.
A final follow-up visit will occur 6 months after you have completed your last training session. This visit will take about two hours. You will be asked to complete some cognitive, visual and physical tests. You will be given questionnaires on mood, fatigue and function.
- Conditions
- Multiple Sclerosis, Cognitive Decline
- Being tested
- Computerized gaming rehabilitation Program 1, Computerized gaming rehabilitation Program 2
- Keywords
- MS, Multiple Sclerosis, Cognitive remediation, Brain training, Physical Therapy
- 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.
Computerized gaming rehabilitation Program 1Device
Brain training games displayed on a large screen paired with physical exercise component. The program involves movements such as reaching, stepping, or stretching in place.
Computerized gaming rehabilitation Program 2Device
Brain training games displayed on a tablet device paired with physical exercise component. The program involves movements such as reaching, stepping, or stretching.
| Study group | Role | What they receive |
|---|---|---|
| Program 1 | Active comparator | Computerized gaming rehabilitation Program 1. Receives: Device: Computerized gaming rehabilitation Program 1 |
| Program 2 | Placebo comparator | Computerized gaming rehabilitation Program 2. Receives: Device: Computerized gaming rehabilitation Program 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in processing speed after 4 weeks of treatment with computerized gaming rehabilitation paired with physical activity 'Program 1', vs. 'Program 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: 4 weeks
Secondary outcomes (4)
Change in attention after 4 weeks of treatment with computerized gaming rehabilitation paired with physical activity 'Program 1', vs. 'Program 2'.
Attention is measured by the Test of Variables of Attention (TOVA). This computerized culture- and language-free test uses both visual and auditory stimuli to assess the speed and accuracy of attentional processing deficits in the domain of attention (Greenberg, 1998). Initially devised for ADHD in children, its predictive power has been demonstrated in other patient groups with attention and memory impairments (Braverman et al., 2006): domains also largely impaired in MS. The TOVA has furthermore been chosen here because positive effects following BBT training in young adults have been observed on this test (ongoing study at the Neuroscape Center at UCSF, unpublished data).
Measured: 4 weeks
Change in visual working memory after 4 weeks of computerized gaming rehabilitation paired with physical activity 'Program 1', vs. 'Program 2'.
Visual working memory will be assessed via performance on 'Filter task', an established assessment of visual working memory Vogel, McCollough, \& Machizawa, 2005).
Measured: 4 weeks
Change in multitasking performance following 4 weeks of computerized paired with physical activity 'Program 1', vs. 'Program 2'.
The Triangle Tracer module of ACE evaluates multitasking abilities and is based on the same principles as Neuroracer, UCSF Neuroscape's paradigm for assessment and training of multitasking (Anguera et al., 2013)
Measured: 4 weeks
Change in working memory following 4 weeks of computerized paired with physical activity 'Program 1', vs. 'Program 2'.
The Brief Visuospatial Memory Test (BVMT) is an immediate non-verbal recall test, and a standardized assessment tool of working memory in MS.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start25 Apr 2019
- Primary completion12 Feb 2025
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Riley Bove, MD, Principal investigator, University of California, San FranciscoArseny Sokolov, MD, Principal investigator, Centre hospitalier universitaire vaudois, Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737825
- Sponsor's protocol ID
- 18-25685
- Status last verified
- Apr 2026
- First submitted
- 6 Nov 2018
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Braverman ER, Chen TJ, Schoolfield J, Martinez-Pons M, Arcuri V, Varshavskiy M, Gordon CA, Mengucci J, Blum SH, Meshkin B, Downs BW, Blum K. Delayed P300 latency correlates with abnormal Test of Variables of Attention (TOVA) in adults and predicts early cognitive decline in a clinical setting. Adv Ther. 2006 Jul-Aug;23(4):582-600. doi: 10.1007/BF02850047.
PubMed 17050501Forbes GB. Clinical utility of the Test of Variables of Attention (TOVA) in the diagnosis of attention-deficit/hyperactivity disorder. J Clin Psychol. 1998 Jun;54(4):461-76. doi: 10.1002/(sici)1097-4679(199806)54:43.0.co;2-q.
PubMed 9623751Anguera JA, Boccanfuso J, Rintoul JL, Al-Hashimi O, Faraji F, Janowich J, Kong E, Larraburo Y, Rolle C, Johnston E, Gazzaley A. Video game training enhances cognitive control in older adults. Nature. 2013 Sep 5;501(7465):97-101. doi: 10.1038/nature12486.
PubMed 24005416Vogel EK, McCollough AW, Machizawa MG. Neural measures reveal individual differences in controlling access to working memory. Nature. 2005 Nov 24;438(7067):500-3. doi: 10.1038/nature04171.
PubMed 16306992
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Cognitive Training for Patients With Cognitive Deficits Due to Multiple Sclerosis: a Pilot Study
- ClinicalTrials.gov ID
- NCT03737825
- Acronym / sponsor ID
- 18-25685
- Conditions
- Multiple Sclerosis, Cognitive Decline
- Keywords
- MS, Multiple Sclerosis, Cognitive remediation, Brain training, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
WHO: 40 participants with a confirmed diagnosis of Multiple Sclerosis (MS) able to engage in moderate physical activity.
WHY: The purpose of this study is to evaluate two computerized brain training tools, which include light physical activity, to see if they can help improve cognitive functions, such as memory and attention, for patients with MS.
WHAT: Complete a set of tests (physical and cognitive) at baseline, wear a Fitbit Flex device at home for the duration of the study, 3 supervised sessions for 4 weeks at UCSF, one visit for physical and cognitive tests at one week after the final supervised session, and one final visit 6 months after the final supervised session.
WHERE: 20 participants at the UCSF Weill Institute for Neurosciences (675 Nelson Rising Lane, San Francisco, CA); 20 participants at Lausanne University Hospital (Rue du Bugnon 46, 1005 Lausanne, Switzerland)
Detailed description
This is a dual-site trial with identical study activities taking place at both locations. If you live in/near San Francisco, study visits will take place at UCSF; if you live in/near Lausanne, Switzerland, study visits will take place at the Lausanne University Hospital.
You will be asked to attend one initial session for cognitive tests and answer questions regarding your medical history to see if you are eligible for the study. This process takes about 20 minutes. If you are eligible you will be asked to schedule the following appointments to participate:
First you will be randomized into one of two different training programs. You will not be able to choose which program you are placed in, but have equal chances of being randomized into each:
- Program 1 involves brain training games displayed on a large screen. Participants will use whole-body movements to complete game tasks. Tasks involve movements such as reaching, stepping, and jogging in place. These movements are tracked by a motion sensor. Stretching, warm-up, and cool down sessions will be mandated prior to and following the tasks.
- Program 2 involves brain training and guided, light physical exercise games on a tablet device. The exercise involves movements such as reaching, stepping, and stretching. Stretching, warm-up, and cool down sessions will be mandated prior to and following the tasks.
Baseline Visit: This session should take about two hours. You will be given some cognitive, visual and physical tests. You will be given questionnaires about your mood, fatigue and function. You will receive a Fitbit Flex to be worn daily for the duration of the study. The Fitbit will track daily active step count, number of active minutes, quality/length of sleep cycles.
Week 1-4 Visits (12 sessions in total): These sessions will be 1 hour and 30 minutes each (Note: the first session will be 2 hours to account for calibrations). You will come in three times a week for four weeks to attend on-site sessions. You will be asked to complete digital, cognitive and physical training at each one of these visits.
Post-Training Visit: You will be asked to come in for an assessment 1 week after completing your last training session. This visit will take about 2 hours. You will be asked to complete some cognitive, visual, and physical tests. You will be given questionnaires on mood, fatigue, and everyday function. You will also return the Fitbit you received at the start of the study.
A final follow-up visit will occur 6 months after you have completed your last training session. This visit will take about two hours. You will be asked to complete some cognitive, visual and physical tests. You will be given questionnaires on mood, fatigue and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Program 1 | Active comparator | Device: Computerized gaming rehabilitation Program 1Computerized gaming rehabilitation Program 1. |
| Program 2 | Placebo comparator | Device: Computerized gaming rehabilitation Program 2Computerized gaming rehabilitation Program 2. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 60 years
- Presence of subjective cognitive complain from patient
- Objective general cognitive impairment: paper-and-pencil Symbol Digit Modalities Test (SDMT) z-score < -0.5 at screening
Key exclusion criteria (6 listed)
- Falls in the past 12 weeks as evaluated in the enrollment interview [Hopkins Falls Grading Scale (Grade >1)]
- Strong risk of falling, assessed using the miniBEST (score< 16)
- Psychiatric co-morbidity or anti-depressive or anxiolytic medication that has been changed over the 6 months preceding consideration for study enrollment
- Colorblindness
- Presence of clinically and/or radiologically confirmed relapses or disease progression in the past 12 weeks.
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 |
|---|---|---|
| Computerized gaming rehabilitation Program 1Brain training games displayed on a large screen paired with physical exercise component. The program involves movements such as reaching, stepping, or stretching in place. | Device | Program 1 |
| Computerized gaming rehabilitation Program 2Brain training games displayed on a tablet device paired with physical exercise component. The program involves movements such as reaching, stepping, or stretching. | Device | Program 2 |
Primary outcome
Change in processing speed after 4 weeks of treatment with computerized gaming rehabilitation paired with physical activity 'Program 1', vs. 'Program 2'.
Time frame: 4 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.
4 secondary outcomes
Change in attention after 4 weeks of treatment with computerized gaming rehabilitation paired with physical activity 'Program 1', vs. 'Program 2'.
Time frame: 4 weeks
Change in visual working memory after 4 weeks of computerized gaming rehabilitation paired with physical activity 'Program 1', vs. 'Program 2'.
Time frame: 4 weeks
Change in multitasking performance following 4 weeks of computerized paired with physical activity 'Program 1', vs. 'Program 2'.
Time frame: 4 weeks
Change in working memory following 4 weeks of computerized paired with physical activity 'Program 1', vs. 'Program 2'.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 17050501Braverman ER, Chen TJ, Schoolfield J, Martinez-Pons M, Arcuri V, Varshavskiy M, Gordon CA, Mengucci J, Blum SH, Meshkin B, Downs BW, Blum K. Delayed P300 latency correlates with abnormal Test of Variables of Attention (TOVA) in adults and predicts early cognitive decline in a clinical setting. Adv Ther. 2006 Jul-Aug;23(4):582-600. doi: 10.1007/BF02850047.
- Background: PubMed 9623751Forbes GB. Clinical utility of the Test of Variables of Attention (TOVA) in the diagnosis of attention-deficit/hyperactivity disorder. J Clin Psychol. 1998 Jun;54(4):461-76. doi: 10.1002/(sici)1097-4679(199806)54:43.0.co;2-q.
- Background: PubMed 24005416Anguera JA, Boccanfuso J, Rintoul JL, Al-Hashimi O, Faraji F, Janowich J, Kong E, Larraburo Y, Rolle C, Johnston E, Gazzaley A. Video game training enhances cognitive control in older adults. Nature. 2013 Sep 5;501(7465):97-101. doi: 10.1038/nature12486.
- Background: PubMed 16306992Vogel EK, McCollough AW, Machizawa MG. Neural measures reveal individual differences in controlling access to working memory. Nature. 2005 Nov 24;438(7067):500-3. doi: 10.1038/nature04171.
- 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
Arseny Sokolov, MD principal investigator
Centre hospitalier universitaire vaudois, Lausanne
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized gaming rehabilitation Program 1 and Computerized gaming rehabilitation Program 2 in people with Multiple Sclerosis and Cognitive Decline, run by University of California, San Francisco at 2 sites in 2 countries.
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 3 inclusion and 6 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 4 weeks of treatment with computerized gaming rehabilitation paired with physical activity 'Program 1', vs. 'Program 2'. (time frame: 4 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 NCT03737825, which also lists 4 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 6 Apr 2026.