Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis

NCT03200899 | Completed Results DMC

• 1 other identifier: 2008-10-0101
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

cognitive rehabilitation

Outcome Measures

Primary Outcomes (3)

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

  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.

  6 months post-intervention

• Use of Compensatory Cognitive Strategies

  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.

  6 months post-intervention

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

  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.

  6 months post intervention

Secondary Outcomes (5)

• Self-Efficacy

  6 months post intervention

• Verbal Fluency

  6 months post intervention

• Nonverbal Learning and Memory

  6 months post intervention

• Auditory Information Processing Speed and Flexibility

  6 months post intervention

• Psychomotor Processing Speed

  6 months post intervention

Study Arms (2)

Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)

EXPERIMENTAL

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

Usual Care plus Computer games

ACTIVE COMPARATOR

Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site.

Other: Usual Care plus computer games

Interventions

MAPSS-MS BEHAVIORAL

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.

Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)

Usual Care plus computer games OTHER

Participants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.

Usual Care plus Computer games

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78701, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Alexa Stuifbergen
• Organization: The University of Texas at Austin

astuifbergen@mail.utexas.edu

+1 (512) 471-4100

Study Officials

• Alexa Stuifbergen, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Dean

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 27, 2017
• Study Start: January 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 10, 2024
• Results First Posted: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: WIll be shared on request in 2020 and beyond
• Access Criteria: Qualified investigators with IRB approval

Locations

US (1)