Clinical trial NCT03200899: Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis
Official title: Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: cognitive rehabilitation
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Neuro-cognitive Competence in Daily Living - California Verbal Learning Test-II
timeFrame: 6 months post-intervention
measure: Use of Compensatory Cognitive Strategies
timeFrame: 6 months post-intervention
measure: Cognitive-related Instrumental Activities of Daily Living (IADL) Among Persons With MS
timeFrame: 6 months post intervention
Secondary outcomes:
measure: Self-Efficacy
timeFrame: 6 months post intervention
measure: Verbal Fluency
timeFrame: 6 months post intervention
measure: Nonverbal Learning and Memory
timeFrame: 6 months post intervention
measure: Auditory Information Processing Speed and Flexibility
timeFrame: 6 months post intervention
measure: Psychomotor Processing Speed
timeFrame: 6 months post intervention
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Alexa Stuifbergen, PhD
role: PRINCIPAL_INVESTIGATOR
References: