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Multiple SclerosisNCT02634567

Attention/Working Memory Rehabilitation in Multiple Sclerosis: A Pilot Project Using Cogmed Working Memory Training

A study testing Cogmed Working Memory Training (CWMT) in people with Multiple Sclerosis, run by London Health Sciences Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients diagnosed with any type of multiple sclerosis (MS) who show objective evidence of attention problems will be randomized to standard medical care (treatment as usual) or attention training, which will be completed at their home using a commercially available attention training task (Cogmed Working Memory… Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Cogmed Working Memory Training (CWMT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteCanada
Study dates
Apr 2016to Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

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 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Males/Females, Ages 18-64, with any type of MS
  • Lower to moderate physical disability
  • Demonstrated impaired attention/working memory on 2 of 3 measures (Patients with a z-score lower than -1.5 on at least 2 of the 3 measures will be characterized as showing attention/working memory deficits)
  • Patients must have a Mac or personal computer (PC) computer at home with access to the internet

Who cannot join

  • Clinical relapse/steroid treatment 1 month prior to study entry
  • Physical disability that prevents completion of study measures or training
  • History of severe mental illness or daily marijuana use
  • Those who do not meet the inclusion criteria.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • London Health Sciences Centre

    London, Ontario, N6A 5A5

Other trials in Canada

About this study

Patients diagnosed with any type of multiple sclerosis (MS) who show objective evidence of attention problems will be randomized to standard medical care (treatment as usual) or attention training, which will be completed at their home using a commercially available attention training task (Cogmed Working Memory Training - CWMT) for 5 weeks. Patients will undergo cognitive testing before and after intervention and at 6 months follow up.

Read the detailed description

MS patients who meet the inclusion criteria of the study showing deficits on at least 2 of 3 attention/working measures who will then be randomized to either a treatment group (cognitive rehabilitation training) or a control group (standard clinical care). Patients must show mild to moderate-severe impairment on 2 out of 3 test measures of processing speed and sustained attention to be included in the study. Participants will undergo cognitive testing (Minimal Assessment of Cognitive Function in MS [MACFIMS] performed at Dr. Morrow's cognitive clinic at Parkwood Hospital) at pre- and post-treatment, and also at 6-months follow-up. Participants will also fill out non-cognitive measures in the form of questionnaires regarding quality of life (QoL), self-efficacy, stress, and copying strategies at both pre and post treatment. In addition, the intervention group will undergo attention training using CWMT for 5 days per week (30-45 minutes daily) for 5 weeks. They will complete this training by themselves in their home. The assigned Cogmed coach will set up the Cogmed program for the duration of the trail on the training group participant's computers. The study will not be able to continue to pay for the Cogmed program after the 5 week training sessions. Participants are welcome to purchase the software themselves after the entire study has ended if they would like at: http://www.cogmed.com/. The CWMT (Cogmed) method consists of 25 training sessions done online. Each participant assigned to the training group will complete eight exercises for five weeks with five sessions every week. The Cogmed program uses an adaptive training approach in which the difficulty level of the training is adjusted in real time (trial by trial basis) based on the trainee's performance. Each session consists of a selection of various tasks that target the different aspects of attention/working memory. Specifically, each session will involve training on visuospatial working memory tasks (e.g., remembering the position of objects in a 4 x 4 Grid) as well as verbal working memory tasks (e.g., remembering phonemes, letters, or digits). Given that adults will be involved in this study, Cogmed QM will be used, a version of the CWMT program adapted for adults. Participants will engage in weekly discussions over the phone for about 1 hour with an assigned Cogmed coach who will provide support and encouragement over the 5 weeks. Additional calls will be made if the Cogmed coaches see the participant is not completing their online training. Each participant will be assigned a Cogmed qualified coach who is responsible for providing structure, motivation, and feedback on training progress in order to optimize training gains. Before Cogmed training begins, each participant in the training group will be visited once by their respective Cogmed coach who will ensure that participants' daily Cogmed sessions will be conducted in a space in their home that is conducive to attention training (e.g., little clutter, private area of the home) and ensure consistency between participants. During training, each participant's performance will be tracked online and will be reviewed by the participant and his/her coach in weekly telephone meetings throughout the five week period. The participant's performance will be tracked online on the Cogmed platform. The Cogmed coaches set up the program for the participants and assign them a username. The Cogmed coaches can track the individual's performance and see who has completed the training based on their username. No Internet Protocol (IP) information will be collected. At the end of training, the coach will summarize the training by telephone with the participant.

Being tested
Cogmed Working Memory Training (CWMT)
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cogmed Working Memory Training (CWMT)Behavioural

    The CWMT (Cogmed) method consists of 25 training sessions done online. Each participant assigned to the training group will complete eight exercises for five weeks with five sessions every week. Each session consists of a selection of various tasks that target the different aspects of attention/working memory. Participants will engage in weekly discussions over the phone for about 1 hour with an assigned Cogmed coach who will provide support and encouragement over the 5 weeks.

Study groups in NCT02634567
Study groupRoleWhat they receive
Treatment as UsualNo interventionThis group will not any training with the Cogmed training program.
Training GroupExperimentalThis group will receive intervention with the Cogmed training program and coach over a period of 5 weeks.
Receives: Behavioral: Cogmed Working Memory Training (CWMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Paced Auditory Serial Addition Test

    Cognitive test; Change pre- to post-test between groups

    Measured: 7 months

  2. Symbol Digit Modalities Test

    Cognitive test; Change pre- to post-test between groups

    Measured: 7 months

  3. Stroop colour word test

    Cognitive test; Change pre- to post-test between groups

    Measured: 7 months

Secondary outcomes (19)
  1. Judgement of Line Orientation

    Cognitive test; Change pre- to post-test between groups

    Measured: 7 months

  2. Controlled Oral Word Association Test

    Cognitive test; Change pre- to post-test between groups

    Measured: 7 months

  3. California Verbal Learning Test

    Cognitive test; Change pre- to post-test between groups

    Measured: 7 months

  4. Brief Visual Memory Test

    Cognitive test; Change pre- to post-test between groups

    Measured: 7 months

  5. Delis-Kaplan Executive Function System Sorting Test

    Cognitive test; Change pre- to post-test between groups

    Measured: 7 months

  6. Beck Depression Inventory - Fast Screen

    Non-cognitive Questionnaire; Change pre- to post-test between groups

    Measured: 7 months

  7. Hospital Anxiety and Depression Scale

    Non-cognitive Questionnaire; Change pre- to post-test between groups

    Measured: 7 months

  8. Fatigue Severity Scale

    Non-cognitive Questionnaire; Change pre- to post-test between groups

    Measured: 7 months

  9. Short Form Health Survey

    Non-cognitive Questionnaire; Change pre- to post-test between groups

    Measured: 7 months

  10. Dysexecutive Questionnaire

    Non-cognitive Questionnaire; Change pre- to post-test between groups in terms of the amount of self-reported issues with executive functions.

    Measured: 7 months

  11. Cognitive Failures Questionnaire

    Non-cognitive Questionnaire; Change pre- to post-test between groups in terms of the amount of self-reported cognitive issues

    Measured: 7 months

  12. BRIEF Cope

    Non-cognitive Questionnaire; Change pre- to post-test between groups

    Measured: 7 months

  13. Social Stress and Support Interview

    Non-cognitive Questionnaire; Change pre- to post-test between groups

    Measured: 7 months

  14. Multiple Sclerosis Neuropsychological Screening Questionnaire

    Non-cognitive Questionnaire; Change pre- to post-test between groups

    Measured: 7 months

  15. Perceived Deficits Questionnaire

    Non-cognitive Questionnaire; Change pre- to post-test between groups

    Measured: 7 months

  16. Visual Spatial Span Board Assessment

    Cognitive Test; Change pre- to post-test between groups in the amount of correct sequencing of repeated taping blocks in forward or reverse order from sequence presented by the examiner.

    Measured: 7 months

  17. Digit Span

    Cognitive Test; Change pre- to post-test between groups in terms of digit sequence memorized and repeated. A span of 3-9 digits will be repeated forwards and backwards after presentation from the examiner.

    Measured: 7 months

  18. Arithmetic

    Cognitive Test; Change pre- to post-test between groups, elementary math presented and solved without a pencil and paper.

    Measured: 7 months

  19. Letter-Number Sequencing

    Cognitive Test; Change pre- to post-test between groups, presented with a combination of letters and numbers; must repeat numbers in ascending order and letters in alphabetical order to examiner.

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2015 (estimated)
  2. Study startApr 2016
  3. Primary completionNov 2018
  4. Study completionDec 2018

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02634567
Sponsor's protocol ID
107343
Status last verified
Aug 2019
First submitted
11 Dec 2015
Last updated
13 Aug 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Cogmed Working Memory Training (CWMT) in people with Multiple Sclerosis, run by London Health Sciences Centre at 1 site in Canada.

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 4 inclusion and 4 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 13 Aug 2019. 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 Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Paced Auditory Serial Addition Test (time frame: 7 months). 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 13 Aug 2019.

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Clinical Trial NCT02634567 | AzTrials