Summary

for people ages 18-64 (full criteria)
study started
estimated completion:
Riley Bove

Description

Summary

Adaptive Body-Brain Training for Patients with Cognitive Deficits due to Multiple Sclerosis: a pilot study WHO: 36 participants with a confirmed diagnosis of Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) able to engage in moderate physical activity. WHY: The purpose of this study is to test whether a computerized cognitive training tool with/or without a physical exercise program can help improve cognitive functions, such as memory and thinking, for patients with MS. WHAT: Complete a set of tests (physical and cognitive) at baseline, where a Fitbit Flex device at home for the duration of the study, 3 supervised sessions for 4 weeks at UCSF, one final follow up visit for physical and cognitive tests 6 months after the final supervised session. WHERE: UCSF Weill Institute for Neurosciences (675 Nelson Rising Lane, San Francisco, CA)

Official Title

Adaptive Body-Brain Training for Patients With Cognitive Deficits Due to Multiple Sclerosis: a Pilot Study

Details

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 45 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 interactive brain training games displayed on a large screen. Participants will use whole-body movements to complete game tasks. Tasks involve aerobic 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 games on a tablet device. Time between alternating game tasks will involve guided, light physical exercise. Exercise tasks involve aerobic 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 one hour. 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 followed by 45 minutes of cognitive and physical assessment at the end of each session.

You will be asked to come in for a final follow-up visit 6 months after you have completed your last training session. This visit will take about 45 minutes. You will be asked to complete some cognitive, visual and physical tests. You will be given questionnaires on mood, fatigue and function. You will return the Fitbit Flex you received at the start of the study.

Keywords

Multiple Sclerosis Clinically Isolated Syndrome Cognitive Decline Sclerosis Cognitive Dysfunction Computerized gaming rehabilitation Program 1 Computerized gaming rehabilitation Program 2 Program 1 Program 2

Eligibility

You can join if…

Open to people ages 18-64

  • Presence of subjective complaint from patient
  • SDMT z-score range (-2 to +1)
  • Visual, motor or brainstem Functional Systems Score (FSS) on the Expanded Disability Status Scale (EDSS) equal or superior to 3
  • Mental FSS on the EDSS above 3
  • Recent brain MRI within past 12 weeks: no lesion progression and no enhancing lesion if performed in prior 4 weeks

You CAN'T join if...

  • Falls or near falls in the past 4 weeks as evaluated in the enrollment interview
  • Strong risk of falling, assessed using the Berg balance scale (score < 45) and Hopkins Falls Graded Scale (Grade > 1)
  • Major psychiatric co-morbidity or antidepressant medication that has been changed over the 6 months preceding consideration for study enrollment
  • Failure in passing Ishihara's Test for Colour Deficiency

Lead Scientist

  • Riley Bove
    Assistant Professor, Neurology. Authored (or co-authored) 62 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Riley Bove, MD
ID
NCT03737825
Study Type
Interventional
Last Updated