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Trial record 5 of 7 for:    C3Po

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

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ClinicalTrials.gov Identifier: NCT02318576
Recruitment Status : Completed
First Posted : December 17, 2014
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Jacob Sosnoff, University of Illinois at Urbana-Champaign

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Cognitive Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Computerized Cognition Testing and Cognitive Motor Interference in MS
Study Start Date : March 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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.
Other: Cognitive Training
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318576


Locations
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United States, Illinois
Motor control research lab
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Investigators
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Principal Investigator: Jacob J Sosnoff, PhD University of Illinois at Urbana-Champaign
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Responsible Party: Jacob Sosnoff, Associate Professor, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT02318576    
Other Study ID Numbers: 15333
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Keywords provided by Jacob Sosnoff, University of Illinois at Urbana-Champaign:
Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases