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Clinical Trials/NCT03200899
NCT03200899
Completed
Not Applicable

Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis

University of Texas at Austin1 site in 1 country183 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Texas at Austin
Enrollment
183
Locations
1
Primary Endpoint
Use of Compensatory Cognitive Strategies
Status
Completed
Last Updated
last year

Overview

Brief Summary

The effects of multiple sclerosis (MS) on cognition, thought to occur in 50-75% of persons with MS, have gained increasing recognition as one of the major disabling symptoms of the disease. While numerous studies have addressed the emotional and physical impact of MS, little attention has been given to strategies that might help manage the cognitive changes commonly experienced by persons with MS. The proposed study will test a novel computer-assisted cognitive rehabilitation intervention, MAPSS-MS (Memory, Attention, & Problem Solving Skills for Persons with MS). The MAPSS-MS integrates the powerful effects of group interventions to build self-efficacy for new cognitive compensatory strategies/behaviors with individual home-based computer-assisted training. The computer training will assist individuals to develop cognitive skills that they can apply to everyday life using the compensatory strategies learned in the class sessions. In the recently completed exploratory study with 61 persons with MS (R21NR011076), the eight-week MAPSS-MS intervention was acceptable and feasible and had medium to large effects on the use of compensatory strategies and performance on neuropsychological tests of verbal memory. The proposed study will test the refined MAPSS-MS intervention with a larger more diverse sample (N=180) across multiple sites, extend the period of post-intervention follow-up to 6 months and establish whether performance improvements on neuropsychological tests make the important transfer to improved neuro-cognitive functioning in everyday life.

The specific aims of this study are to: (1) Evaluate the efficacy of the novel MAPSS-MS cognitive rehabilitation intervention to improve overall neuro-cognitive competence in activities of daily living including verbal memory performance, use of compensatory cognitive strategies and performance on cognitive-related instrumental activities of daily living (IADL) among persons with MS; (2) Evaluate the efficacy of the MAPSS-MS intervention to improve self-efficacy and related aspects of cognitive performance (non-verbal learning/memory, information processing speed and attention, verbal fluency and complex scanning and tracking) among persons with MS; and (3) Determine the number of intervention participants who achieve and maintain their self-identified cognitive goals three and six months following the intervention. The effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with a comparison group receiving usual care computer games. Measurements of study variables will occur at baseline, immediately after the MAPSS-MS intervention, and three months and six months after the intervention is complete. Statistical analysis will include descriptive statistics and HLM analysis to account for the nested design. The intent-to-treat approach will be used.

Public Health Statement: This research will provide new knowledge about an innovative intervention to improve memory, use of compensatory strategies, and performance of cognitive activities and instrumental activities of daily living for persons with MS. If effective, the intervention would provide a new and feasible approach to target a serious, debilitating problem commonly experienced by persons with MS.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
June 2018
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alexa Stuifbergen

Professor and Dean

University of Texas at Austin

Eligibility Criteria

Inclusion Criteria

  • Clinically definite diagnosis of MS;
  • Age 18 to 60;
  • Capable of understanding and complying with the study protocol;
  • Able to read and write in English;
  • Visual acuity of at least 20/70 with correction in order to work on the computer screen;
  • Stable disease at the time of entry into the study (relapse free for at least 90 days);
  • Subjective concerns about their cognitive functioning (based on the Perceived Deficits Questionnaire); and
  • Home internet access;

Exclusion Criteria

  • Other medical causes of dementia or other neurological disorders that may impact cognition or emotions;
  • Evidence of major psychiatric disorder; or
  • Major functional limitations that preclude them from participating in the study.

Outcomes

Primary Outcomes

Use of Compensatory Cognitive Strategies

Time Frame: 6 months post-intervention

Scores on the Strategy Subscale of the Multi-Factorial Memory Memory Questionnaire. The subscale includes 19 various memory aids and strategies and respondents are asked to rate how frequently they used each strategy during the past 2 weeks using a 5 point scale (never to all the time). Scores can range from 0 to 76. HIgher scores indicate greater use of compensatory memory strategies.

Neuro-cognitive Competence in Daily Living - California Verbal Learning Test-II

Time Frame: 6 months post-intervention

Verbal memory performance (verbal learning and remembering) as measured by performance on the California Verbal Learning Test II (CVLT-II). Total score represents the number of words recalled from a 16 item list over 5 trials. Higher scores represent greater verbal learning and remembering. Scores can range from 0 to 80.

Cognitive-related Instrumental Activities of Daily Living (IADL) Among Persons With MS

Time Frame: 6 months post intervention

Scores on the Everyday Problems Test - Revised (EPT-R). This scale assess the cognitive ability to reason and solve problems encountered in daily living. The revised version included 30 items and scores can range from 0 to 30. HIgher scores indicate better performance on problem solving.

Secondary Outcomes

  • Self-Efficacy(6 months post intervention)
  • Nonverbal Learning and Memory(6 months post intervention)
  • Auditory Information Processing Speed and Flexibility(6 months post intervention)
  • Verbal Fluency(6 months post intervention)
  • Psychomotor Processing Speed(6 months post intervention)

Study Sites (1)

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