Clinical trial NCT03737825: Computerized Cognitive Training in MS
Official title: Computerized Cognitive Training for Patients With Cognitive Deficits Due to Multiple Sclerosis: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Cognitive Decline
Keywords: MS
Multiple Sclerosis
Cognitive remediation
Brain training
Physical Therapy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in processing speed after 4 weeks of treatment with computerized gaming rehabilitation paired with physical activity 'Program 1', vs. 'Program 2'.
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in attention after 4 weeks of treatment with computerized gaming rehabilitation paired with physical activity 'Program 1', vs. 'Program 2'.
timeFrame: 4 weeks
measure: Change in visual working memory after 4 weeks of computerized gaming rehabilitation paired with physical activity 'Program 1', vs. 'Program 2'.
timeFrame: 4 weeks
measure: Change in multitasking performance following 4 weeks of computerized paired with physical activity 'Program 1', vs. 'Program 2'.
timeFrame: 4 weeks
measure: Change in working memory following 4 weeks of computerized paired with physical activity 'Program 1', vs. 'Program 2'.
timeFrame: 4 weeks
Other outcomes:
measure: Change in mood after 4 weeks treatment with Program 1 vs. Program 2.
timeFrame: 4 weeks
measure: Change in fatigue after 4 weeks treatment with Program 1 vs. Program 2.
timeFrame: 4 weeks
measure: Improvement in MS-related outcomes after 4 weeks treatment with Program 1 vs. Program 2.
timeFrame: 4 weeks
measure: Improvement in cognition outcomes after 4 weeks treatment with Program 1 vs. Program 2.
timeFrame: 4 weeks
measure: Change in attentional behavior after 4 weeks of treatment with Program 1 vs Program 2.
timeFrame: 4 weeks
measure: Change in anxiety after 4 weeks of treatment with Program 1 vs Program 2.
timeFrame: 4 weeks
Locations:
city: San Francisco
country: United States
facility: Weill Institute for Neurosciences, University of California, San Francisco
state: California
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital (CHUV)
Study officials:
affiliation: University of California, San Francisco
name: Riley Bove, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre hospitalier universitaire vaudois, Lausanne
name: Arseny Sokolov, MD
role: PRINCIPAL_INVESTIGATOR
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citation: 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.
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