Computerized Cognitive Training in MS
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Treatments
Details and patient eligibility
About
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)
Full 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.
Enrollment
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Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
2 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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