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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

Tracking Information
First Submitted Date  ICMJE December 9, 2014
First Posted Date  ICMJE December 17, 2014
Last Update Posted Date October 26, 2016
Study Start Date  ICMJE March 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Computerized Cognition Testing and Cognitive Motor Interference in MS
Official Title  ICMJE Computerized Cognition Testing and Cognitive Motor Interference in MS
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Cognitive Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2016)
29
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2014)
30
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02318576
Other Study ID Numbers  ICMJE 15333
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jacob Sosnoff, University of Illinois at Urbana-Champaign
Study Sponsor  ICMJE University of Illinois at Urbana-Champaign
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jacob J Sosnoff, PhD University of Illinois at Urbana-Champaign
PRS Account University of Illinois at Urbana-Champaign
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP