NCT03737825|CompletedFDA Device
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Sponsor study identifier
interventional
2
2 countries
2
Study Start
April 25, 2019
Actual (reported)Primary Completion
February 12, 2025
Actual (reported)Study Completion
February 12, 2025
Actual (reported)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)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 12, 2025
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 6, 2018
Actual (reported)November 13, 2018
Actual (reported)April 25, 2019
Actual (reported)February 12, 2025
Actual (reported)February 12, 2025
Actual (reported)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.
4 weeks
Change in attention after 4 weeks of treatment with computerized gaming rehabilitation paired with physical activity 'Program 1', vs. 'Program 2'.
4 weeks
Change in visual working memory after 4 weeks of computerized gaming rehabilitation paired with physical activity 'Program 1', vs. 'Program 2'.
4 weeks
Change in multitasking performance following 4 weeks of computerized paired with physical activity 'Program 1', vs. 'Program 2'.
4 weeks
Change in working memory following 4 weeks of computerized paired with physical activity 'Program 1', vs. 'Program 2'.
4 weeks
Change in mood after 4 weeks treatment with Program 1 vs. Program 2.
4 weeks
Change in fatigue after 4 weeks treatment with Program 1 vs. Program 2.
4 weeks
Improvement in MS-related outcomes after 4 weeks treatment with Program 1 vs. Program 2.
4 weeks
Computerized gaming rehabilitation Program 1.
Computerized gaming rehabilitation Program 2.
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.
Brain training games displayed on a tablet device paired with physical exercise component. The program involves movements such as reaching, stepping, or stretching.
Weill Institute for Neurosciences, University of California, San Francisco
San Francisco, California, 94158, United States
Lausanne University Hospital (CHUV)
Lausanne, 1005, Switzerland
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.
Forbes 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.
Riley Bove, MD
University of California, San Francisco
Arseny Sokolov, MD
Centre hospitalier universitaire vaudois, Lausanne
2 participants (actual enrollment reported by the registry).
First Submitted
November 6, 2018
First Posted
November 13, 2018
Study Start
April 25, 2019
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Anguera 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.
Vogel 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.
Primary Completion
February 12, 2025
Actual (reported)Study Completion
February 12, 2025
Actual (reported)Last Updated
April 6, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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