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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Multiple Sclerosis
- 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 group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | This group will not any training with the Cogmed training program. |
| Training Group | Experimental | This 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.
Paced Auditory Serial Addition Test
Cognitive test; Change pre- to post-test between groups
Measured: 7 months
Symbol Digit Modalities Test
Cognitive test; Change pre- to post-test between groups
Measured: 7 months
Stroop colour word test
Cognitive test; Change pre- to post-test between groups
Measured: 7 months
Secondary outcomes (19)
Judgement of Line Orientation
Cognitive test; Change pre- to post-test between groups
Measured: 7 months
Controlled Oral Word Association Test
Cognitive test; Change pre- to post-test between groups
Measured: 7 months
California Verbal Learning Test
Cognitive test; Change pre- to post-test between groups
Measured: 7 months
Brief Visual Memory Test
Cognitive test; Change pre- to post-test between groups
Measured: 7 months
Delis-Kaplan Executive Function System Sorting Test
Cognitive test; Change pre- to post-test between groups
Measured: 7 months
Beck Depression Inventory - Fast Screen
Non-cognitive Questionnaire; Change pre- to post-test between groups
Measured: 7 months
Hospital Anxiety and Depression Scale
Non-cognitive Questionnaire; Change pre- to post-test between groups
Measured: 7 months
Fatigue Severity Scale
Non-cognitive Questionnaire; Change pre- to post-test between groups
Measured: 7 months
Short Form Health Survey
Non-cognitive Questionnaire; Change pre- to post-test between groups
Measured: 7 months
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
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
BRIEF Cope
Non-cognitive Questionnaire; Change pre- to post-test between groups
Measured: 7 months
Social Stress and Support Interview
Non-cognitive Questionnaire; Change pre- to post-test between groups
Measured: 7 months
Multiple Sclerosis Neuropsychological Screening Questionnaire
Non-cognitive Questionnaire; Change pre- to post-test between groups
Measured: 7 months
Perceived Deficits Questionnaire
Non-cognitive Questionnaire; Change pre- to post-test between groups
Measured: 7 months
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
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
Arithmetic
Cognitive Test; Change pre- to post-test between groups, elementary math presented and solved without a pencil and paper.
Measured: 7 months
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.
- First posted18 Dec 2015 (estimated)
- Study startApr 2016
- Primary completionNov 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Morrow, London Health Sciences Centre
- Investigators
- Sarah A Morrow, MD, MS, FRCPC (Neurology), Principal investigator, London Health Sciences Centre
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention/Working Memory Rehabilitation in Multiple Sclerosis: A Pilot Project Using Cogmed Working Memory Training
- ClinicalTrials.gov ID
- NCT02634567
- Acronym / sponsor ID
- 107343
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Nov 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | –This group will not any training with the Cogmed training program. |
| Training Group | Experimental | Behavioral: Cogmed Working Memory Training (CWMT)This group will receive intervention with the Cogmed training program and coach over a period of 5 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Cogmed Working Memory Training (CWMT)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. | Behavioural | Training Group |
Primary outcome
Paced Auditory Serial Addition Test
Time frame: 7 months
Cognitive test; Change pre- to post-test between groups
Symbol Digit Modalities Test
Time frame: 7 months
Cognitive test; Change pre- to post-test between groups
Stroop colour word test
Time frame: 7 months
Cognitive test; Change pre- to post-test between groups
19 secondary outcomes
Judgement of Line Orientation
Time frame: 7 months
Controlled Oral Word Association Test
Time frame: 7 months
California Verbal Learning Test
Time frame: 7 months
Brief Visual Memory Test
Time frame: 7 months
Delis-Kaplan Executive Function System Sorting Test
Time frame: 7 months
Beck Depression Inventory - Fast Screen
Time frame: 7 months
Hospital Anxiety and Depression Scale
Time frame: 7 months
Fatigue Severity Scale
Time frame: 7 months
Short Form Health Survey
Time frame: 7 months
Dysexecutive Questionnaire
Time frame: 7 months
Cognitive Failures Questionnaire
Time frame: 7 months
BRIEF Cope
Time frame: 7 months
Social Stress and Support Interview
Time frame: 7 months
Multiple Sclerosis Neuropsychological Screening Questionnaire
Time frame: 7 months
Perceived Deficits Questionnaire
Time frame: 7 months
Visual Spatial Span Board Assessment
Time frame: 7 months
Digit Span
Time frame: 7 months
Arithmetic
Time frame: 7 months
Letter-Number Sequencing
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
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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.
Sarah A Morrow, MD, MS, FRCPC (Neurology) principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
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.