Computerized Cognitive Training in MS

NCT03737825 | Completed FDA Device

• 1 other identifier: 18-25685
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 2

Brief 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 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)

Conditions

Multiple Sclerosis; Cognitive Decline

Keywords

MS; Multiple Sclerosis; Cognitive remediation; Brain training; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Other Outcomes (6)

• 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

Study Arms (2)

Program 1

ACTIVE COMPARATOR

Computerized gaming rehabilitation Program 1.

Device: Computerized gaming rehabilitation Program 1

Program 2

PLACEBO COMPARATOR

Computerized gaming rehabilitation Program 2.

Device: Computerized gaming rehabilitation Program 2

Interventions

Computerized gaming rehabilitation Program 1 DEVICE

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.

Program 1

Computerized gaming rehabilitation Program 2 DEVICE

Brain training games displayed on a tablet device paired with physical exercise component. The program involves movements such as reaching, stepping, or stretching.

Program 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (2)

Weill Institute for Neurosciences, University of California, San Francisco

San Francisco, California, 94158, United States

Location

Lausanne University Hospital (CHUV)

Lausanne, 1005, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 17050501 BACKGROUND

• 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.

  PMID: 9623751 BACKGROUND

• 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.

  PMID: 24005416 BACKGROUND

• 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.

  PMID: 16306992 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Riley Bove, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Arseny Sokolov, MD

  Centre hospitalier universitaire vaudois, Lausanne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Masking: Triple (Participant, Investigator, Outcomes Assessor) Study assessment administrator is blinded to what digital tool the subject has been assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 13, 2018
• Study Start: April 25, 2019
• Primary Completion: February 12, 2025
• Study Completion: February 12, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); US (1)