Multiple SclerosisNCT03200899
Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis
A study testing MAPSS-MS in people with Multiple Sclerosis, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MAPSS-MS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Austin
Austin, Texas, 78701
About this study
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
- Being tested
- MAPSS-MS, Usual Care plus computer games
- Keywords
- cognitive rehabilitation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAPSS-MSBehavioural
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 gamesOther
Participants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.
| Study group | Role | What they receive |
|---|---|---|
| Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Experimental | 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. Receives: Behavioral: MAPSS-MS |
| Usual Care plus Computer games | Active comparator | Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site. Receives: Other: Usual Care plus computer games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuro-cognitive Competence in Daily Living - California Verbal Learning Test-II
Verbal memory performance (verbal learning and remembering) as measured by performance on the California Verbal Learning Test II (CVLT-II). Total score represents the number of words recalled from a 16 item list over 5 trials. Higher scores represent greater verbal learning and remembering. Scores can range from 0 to 80.
Measured: 6 months post-intervention
Use of Compensatory Cognitive Strategies
Scores on the Strategy Subscale of the Multi-Factorial Memory Memory Questionnaire. The subscale includes 19 various memory aids and strategies and respondents are asked to rate how frequently they used each strategy during the past 2 weeks using a 5 point scale (never to all the time). Scores can range from 0 to 76. HIgher scores indicate greater use of compensatory memory strategies.
Measured: 6 months post-intervention
Cognitive-related Instrumental Activities of Daily Living (IADL) Among Persons With MS
Scores on the Everyday Problems Test - Revised (EPT-R). This scale assess the cognitive ability to reason and solve problems encountered in daily living. The revised version included 30 items and scores can range from 0 to 30. HIgher scores indicate better performance on problem solving.
Measured: 6 months post intervention
Secondary outcomes (5)
Self-Efficacy
Scores on the 17 item general self-efficacy scale. Respondents rate their confidence in their ability to affect outcomes in various contexts and situations using a 5-point Likert scale. Scores can range from 17 to 85 with higher scores representing greater perceived self-efficacy expectations.
Measured: 6 months post intervention
Verbal Fluency
Controlled Oral Word Association Test (COWAT) is a measure of verbal fluency and word finding. It requires participants to generate words from initial letters (normally F, A and S) under time constraints, normally 60 seconds per letter. The score reflects the number of words generated across the trials and can vary from 0 to the maximum number generated. Higher scores reflect a greater number of words and greater fluency and word finding.
Measured: 6 months post intervention
Nonverbal Learning and Memory
Brief Visuospatial Memory Test, 2nd ed (BVMT-R) asses visuospatial memory and was used as a measure of non-verbal learning and memory. The total recall score was used in this study and this score represents the sum of all valid items generated across learning trials 1-3.
In each trial, 0-12 points can be obtained. The recognition (yes/no) is scored by one or zero points with a maximum of 12 points. The total score for the total recall ranges from 0 to 36. HIgher scores indicate better memory and recall.
Measured: 6 months post intervention
Auditory Information Processing Speed and Flexibility
The Paced Auditory Serial Addition Test (PASAT) - 3 second was used as the measure of auditory information processing speed and flexibility. Scores represent the number of correct responses during the 3 minute test and can range from 0 to 60. Higher scores indicate better information processing speed and flexibility.
Measured: 6 months post intervention
Psychomotor Processing Speed
The Symbol Digit Modalities Test (SDMT) was used to measure psychomotor processing speed, complex scanning and visual tracking. Respondents have 90 seconds to pair digits/numbers with abstract geometric symbols. Total scores represent the number of correct matches within the time period and can range from 0 to 110. Higher scores reflect better information processing speed.
Measured: 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study startJan 2014
- Primary completionMar 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexa Stuifbergen, University of Texas at Austin
- Investigators
- Alexa Stuifbergen, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200899
- Sponsor's protocol ID
- 2008-10-0101
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2017
- Last updated
- 10 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data files will be de-identified and data will be available on request to the investigators - estimated availability 2020
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03200899
- Acronym / sponsor ID
- 2008-10-0101
- Conditions
- Multiple Sclerosis
- Keywords
- cognitive rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Posted 10 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Experimental | Behavioral: MAPSS-MSParticipants 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. |
| Usual Care plus Computer games | Active comparator | Other: Usual Care plus computer gamesParticipants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAPSS-MSMAPSS-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. | Behavioural | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) |
| Usual Care plus computer gamesParticipants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website. | Other | Usual Care plus Computer games |
Primary outcome
Neuro-cognitive Competence in Daily Living - California Verbal Learning Test-II
Time frame: 6 months post-intervention
Verbal memory performance (verbal learning and remembering) as measured by performance on the California Verbal Learning Test II (CVLT-II). Total score represents the number of words recalled from a 16 item list over 5 trials. Higher scores represent greater verbal learning and remembering. Scores can range from 0 to 80.
Use of Compensatory Cognitive Strategies
Time frame: 6 months post-intervention
Scores on the Strategy Subscale of the Multi-Factorial Memory Memory Questionnaire. The subscale includes 19 various memory aids and strategies and respondents are asked to rate how frequently they used each strategy during the past 2 weeks using a 5 point scale (never to all the time). Scores can range from 0 to 76. HIgher scores indicate greater use of compensatory memory strategies.
Cognitive-related Instrumental Activities of Daily Living (IADL) Among Persons With MS
Time frame: 6 months post intervention
Scores on the Everyday Problems Test - Revised (EPT-R). This scale assess the cognitive ability to reason and solve problems encountered in daily living. The revised version included 30 items and scores can range from 0 to 30. HIgher scores indicate better performance on problem solving.
5 secondary outcomes
Self-Efficacy
Time frame: 6 months post intervention
Verbal Fluency
Time frame: 6 months post intervention
Nonverbal Learning and Memory
Time frame: 6 months post intervention
Auditory Information Processing Speed and Flexibility
Time frame: 6 months post intervention
Psychomotor Processing Speed
Time frame: 6 months post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data files will be de-identified and data will be available on request to the investigators - estimated availability 2020
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexa Stuifbergen, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAPSS-MS in people with Multiple Sclerosis, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuro-cognitive Competence in Daily Living - California Verbal Learning Test-II (time frame: 6 months post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.