Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis

NCT ID: NCT03200899

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2018-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

MAPSS-MS

Intervention Type: 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.

Usual Care plus Computer games

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

Group Type: ACTIVE_COMPARATOR

Usual Care plus computer games

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

Usual Care plus computer games

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Alexa Stuifbergen

Professor and Dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexa Stuifbergen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

The University of Texas at Austin

Austin, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2008-10-0101

Identifier Type: -

Identifier Source: org_study_id