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Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200899
Recruitment Status : Unknown
Verified November 2017 by Alexa Stuifbergen, University of Texas at Austin.
Recruitment status was:  Active, not recruiting
First Posted : June 27, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Alexa Stuifbergen, University of Texas at Austin

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: MAPSS-MS Other: Usual Care plus computer games Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: Care providers are not informed of the participant's participation in a particular arm. Staff collecting outcome data are not aware of the participant's assignment to intervention or usual care.
Primary Purpose: Supportive Care
Official Title: Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis
Actual Study Start Date : January 2014
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)
Participants randomized to this arm receive the MAPSS-MS intervention. The MAPSS-MS is an an 8 week computer assisted cognitive rehabilitation intervention. The group based component of the intervention emphasizes use of compensatory cognitive strategies as well as lifestyle modifications to enhance cognition. Participants also complete home computer training (minimum 3 times per week for 45 minutes) using a special suite of games designed by Lumosity.
Behavioral: MAPSS-MS
MAPSS-MS is a computer-assisted cognitive rehabilitation intervention. It is a combination of home computer training and 8-weeks of group sessions on lifestyle change and compensatory cognitive strategies.

Active Comparator: Usual Care plus Computer games
Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site.
Other: Usual Care plus computer games
Participants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.




Primary Outcome Measures :
  1. Neuro-cognitive competence in daily living - Verbal Memory [ Time Frame: 6 months post-intervention ]
    Verbal memory performance as measured by performance on the CVLT

  2. Use of Compensatory Cognitive Strategies [ Time Frame: 6 months post-intervention ]
    Scores on the Memory Compensatory Strategies Scale

  3. 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


Secondary Outcome Measures :
  1. Self-Efficacy [ Time Frame: 6 months post intervention ]
    Scores on the general self-efficacy scale

  2. Verbal fluency [ Time Frame: 6 months post intervention ]
    Controlled Oral Word Association Test (COWAT)

  3. Nonverbal learning and memory [ Time Frame: 6 months post intervention ]
    Brief Visuospatial Memory Test, 2nd ed (BVMT-R)

  4. Auditory information processing speed and flexibility [ Time Frame: 6 months post intervention ]
    Paced Auditory Serial Addition Test (PASAT)

  5. complex scanning and visual tracking [ Time Frame: 6 months post intervention ]
    Symbol Digit Modalities Test (SDMT)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

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): NCT03200899


Locations
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United States, Texas
The University of Texas at Austin
Austin, Texas, United States, 78701
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Alexa Stuifbergen, PhD University of Texas at Austin
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Responsible Party: Alexa Stuifbergen, Professor and Dean, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03200899    
Other Study ID Numbers: 2008-10-0101
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data files will be de-identified and data will be available on request to the investigators - estimated availability 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexa Stuifbergen, University of Texas at Austin:
cognitive rehabilitation
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