Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03200899
• Other study ID #: 2008-10-0101
• Status: Active, not recruiting
• Phase: N/A
• First received: June 21, 2017
• Last updated: November 9, 2017
• Start date: January 2014
• Est. completion date: June 2018

Study information

• Verified date: November 2017
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: June 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Other:
• Usual Care plus computer games
Participants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.

Locations

Country	Name	City	State
United States	The University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuro-cognitive competence in daily living - Verbal Memory	Verbal memory performance as measured by performance on the CVLT	6 months post-intervention
Primary	Use of Compensatory Cognitive Strategies	Scores on the Memory Compensatory Strategies Scale	6 months post-intervention
Primary	Cognitive-related instrumental activities of daily living (IADL) among persons with MS	Scores on the Everyday Problems Test - Revised	6 months post intervention
Secondary	Self-Efficacy	Scores on the general self-efficacy scale	6 months post intervention
Secondary	Verbal fluency	Controlled Oral Word Association Test (COWAT)	6 months post intervention
Secondary	Nonverbal learning and memory	Brief Visuospatial Memory Test, 2nd ed (BVMT-R)	6 months post intervention
Secondary	Auditory information processing speed and flexibility	Paced Auditory Serial Addition Test (PASAT)	6 months post intervention
Secondary	complex scanning and visual tracking	Symbol Digit Modalities Test (SDMT)	6 months post intervention