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Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MAPSS-MS
Usual Care plus computer games
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring cognitive rehabilitation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Texas at Austin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Usual Care plus Computer games

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Neuro-cognitive competence in daily living - Verbal Memory
Verbal memory performance as measured by performance on the CVLT
Use of Compensatory Cognitive Strategies
Scores on the Memory Compensatory Strategies Scale
Cognitive-related instrumental activities of daily living (IADL) among persons with MS
Scores on the Everyday Problems Test - Revised

Secondary Outcome Measures

Self-Efficacy
Scores on the general self-efficacy scale
Verbal fluency
Controlled Oral Word Association Test (COWAT)
Nonverbal learning and memory
Brief Visuospatial Memory Test, 2nd ed (BVMT-R)
Auditory information processing speed and flexibility
Paced Auditory Serial Addition Test (PASAT)
complex scanning and visual tracking
Symbol Digit Modalities Test (SDMT)

Full Information

First Posted
June 21, 2017
Last Updated
November 9, 2017
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT03200899
Brief Title
Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis
Official Title
Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (Actual)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
cognitive rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes 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.
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care plus Computer games
Arm Type
Active Comparator
Arm Description
Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site.
Intervention Type
Behavioral
Intervention Name(s)
MAPSS-MS
Intervention Description
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
Other
Intervention Name(s)
Usual Care plus computer games
Intervention Description
Participants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.
Primary Outcome Measure Information:
Title
Neuro-cognitive competence in daily living - Verbal Memory
Description
Verbal memory performance as measured by performance on the CVLT
Time Frame
6 months post-intervention
Title
Use of Compensatory Cognitive Strategies
Description
Scores on the Memory Compensatory Strategies Scale
Time Frame
6 months post-intervention
Title
Cognitive-related instrumental activities of daily living (IADL) among persons with MS
Description
Scores on the Everyday Problems Test - Revised
Time Frame
6 months post intervention
Secondary Outcome Measure Information:
Title
Self-Efficacy
Description
Scores on the general self-efficacy scale
Time Frame
6 months post intervention
Title
Verbal fluency
Description
Controlled Oral Word Association Test (COWAT)
Time Frame
6 months post intervention
Title
Nonverbal learning and memory
Description
Brief Visuospatial Memory Test, 2nd ed (BVMT-R)
Time Frame
6 months post intervention
Title
Auditory information processing speed and flexibility
Description
Paced Auditory Serial Addition Test (PASAT)
Time Frame
6 months post intervention
Title
complex scanning and visual tracking
Description
Symbol Digit Modalities Test (SDMT)
Time Frame
6 months post intervention

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexa Stuifbergen, PhD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data files will be de-identified and data will be available on request to the investigators - estimated availability 2020

Learn more about this trial

Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis

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