Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT03200899

What it found

Missed its main goal

The main measure did not show a significant benefit.

MeasureEstimate95% CIp
Cognitive-related Instrumental Activities of Daily Living (IADL) Among Persons With MS 0.129
Use of Compensatory Cognitive Strategies 0.750
Neuro-cognitive Competence in Daily Living - California Verbal Learning Test-II 0.926

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • MAPSS-MS

Compared with

  • Usual Care plus computer games

Results by group

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

6 months post-intervention

GroupValueIntervalNumber analysed
Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)56.1 units on a scale12.9 (Standard Deviation)93
Usual Care Plus Computer Games53.6 units on a scale12.9 (Standard Deviation)90

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

56.1

Usual Care Plus Computer Games

53.6

p = 0.926

Use of Compensatory Cognitive Strategies

6 months post-intervention

GroupValueIntervalNumber analysed
Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)40.2 units on a scale11 (Standard Deviation)93
Usual Care Plus Computer Games39.5 units on a scale11.2 (Standard Deviation)90

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

40.2

Usual Care Plus Computer Games

39.5

p = 0.750

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

6 months post intervention

GroupValueIntervalNumber analysed
Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)24.2 units on a scale4.8 (Standard Deviation)93
Usual Care Plus Computer Games23.5 units on a scale4.4 (Standard Deviation)90

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

24.2

Usual Care Plus Computer Games

23.5

p = 0.129

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)930 (0.0%)0
Usual Care Plus Computer Games900 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

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

    6 months post-intervention

    Thinking and memory
  • Use of Compensatory Cognitive Strategies

    6 months post-intervention

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

    6 months post intervention

    Thinking and memory

Other measures (5)

  • Self-Efficacy

    6 months post intervention

  • Verbal Fluency

    6 months post intervention

  • Nonverbal Learning and Memory

    6 months post intervention

    Thinking and memory
  • Auditory Information Processing Speed and Flexibility

    6 months post intervention

    Thinking and memory
  • Psychomotor Processing Speed

    6 months post intervention

    Thinking and memory

Who could take part

MS (type not specified) · 18 to 60

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Jan 2014

    2. Main results due

      Mar 2018

    3. Finished

      Jun 2018

    4. Results posted

      Jul 2024

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