Computerized Cognition Testing and Cognitive Motor Interference in MS (C3PO)

October 25, 2016 updated by: Jacob Sosnoff, University of Illinois at Urbana-Champaign
This study seeks to examine whether 12 weeks of home-based computerized cognitive training on Cognitive Motor Interference (CMI) will improve walking and cognitive function in persons with MS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Walking and cognitive impairments are common in persons with multiple sclerosis (MS). Approximately 85% of persons with MS report walking as a major limitation, whereas 65% experience cognitive dysfunction. Traditionally, walking and cognition have been viewed as unrelated, but there is evidence of cognitive-motor interference (CMI). CMI is believed to stem from damage to common neural substances responsible for cognitive and motor functions. Recent evidence supports cognitive-motor interference in persons with MS. For example, there is evidence that walking performance declines when performed in conjunction with a simultaneous cognitive task (i.e., dual task cost [DTC] of walking). This decline in walking performance is greater in persons with MS compared to healthy control and is associated with walking impairment. The degree of CMI during walking is associated with walking performance and cognitive function in people with MS. For instance, CMI has been found to be related to general cognitive function and self-reported everyday cognitive errors in people with MS with minimal disability.

Cognitive-motor interference during mobility tasks is of practical and clinical importance because it has been linked to decreased community mobility and a greater risk of falls in other clinical populations such as stoke, Parkinson's disease and the elderly. We have recently demonstrated that the degree of CMI during walking was associated with physiological fall risk in MS, whereas gait velocity in and of itself was not.

Evidence gathered from other special populations suggests that CMI can be minimized with interventions. However, there is no research on rehabilitation strategies on CMI in people with MS. One possible approach for improving cognitive function and reducing CMI involves computerized cognitive testing. This approach capitalizes on neural plasticity and has been found to improve cognitive function, walking and balance in healthy older adults. Although there is limited preliminary data suggesting this type of training may improve cognitive function in people with MS, there is no extant data indicating computerized cognitive training will impact mobility. Based on association between cognitive and motor function in people with MS, it is possible that cognitive training may lead to improvements in walking performance as seen in other clinical populations. One major advantage of computerized cognitive training is that it can be completed without direct supervision and in one's home to minimize various barriers to clinic-based rehabilitation.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Urbana, Illinois, United States, 61801
        • Motor control research lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • medically confirmed MS diagnosis, relapse free in the last 30 days, willingness to complete 12 week intervention, a computer with Internet access and capacity to run the cognitive training software, and a willingness to travel twice to our research lab.

Exclusion Criteria:

  • Non-ambulatory, inability to see/read computer screen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
This group will do nothing for the 12 week program.
Experimental: Cognitive Trained Group
This group will train three time a week for one hour on the given computerized cognitive training website for the 12 week program.
Computerized Cognitive Training: The online computer training program will be administered on the participants' home computer. The training program will consist of a total of 36 sessions (3 times/week for 12 weeks). Each session will last no more than 60 minutes and consist of five different cognitive exercises designed to improve cognitive processing speed, memory and executive function. All exercises will involve visual stimuli and a motor response (key or button press). Exercises will be adaptive to participants' individual ability and start with minimal difficulty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive motor interference meausred by the percent change in walking velocity from single (walking only) to dual task (walking while thinking).
Time Frame: 12 weeks
CMI will be operationalized as the percent change in walking velocity from single (walking only) to dual task (walking while thinking). Participants will complete a total of 4 walking trials over a 20' pressure sensitive (Zeno™) walkway at a comfortable pace. Half of the trials will be conducted while reciting every other letter of the alphabet (i.e. N, P, R, etc). Each trial will start with a different letter to minimize practice effects. The order of the dual task conditions will be counter balanced. Prior to walking trails participants will complete the alternating letter task for two 10-second trials while seated.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Function
Time Frame: 12 weeks
Cognition will indexed at each assessment utilizing the brief international cognitive assessment for MS (BICAMS) which is composed of the symbol digit modalities test (SDMT), California verbal learning test-II (CVLT-II) and the revised brief visuospatial memory test (BVMT). Respectively, these validated tests quantify cognitive processing speed, memory and executive function. All cognitive tests will be performed in an environment free of distractions. We note that these tests are valid and reliable in persons with MS.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jacob J Sosnoff, PhD, University of Illinois at Urbana-Champaign

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

December 9, 2014

First Submitted That Met QC Criteria

December 11, 2014

First Posted (Estimate)

December 17, 2014

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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