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

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02634567
• Other study ID #: 107343
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2019
• Source: London Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Training - CWMT) for 5 weeks. Patients will undergo cognitive testing before and after intervention and at 6 months follow up.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Gender Both: both female and male participants are being studied

Age Limits Minimum Age: 18 years Maximum Age: 64 years

Accepts Healthy Volunteers? No

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
London Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paced Auditory Serial Addition Test	Cognitive test; Change pre- to post-test between groups	7 months
Primary	Symbol Digit Modalities Test	Cognitive test; Change pre- to post-test between groups	7 months
Primary	Stroop colour word test	Cognitive test; Change pre- to post-test between groups	7 months
Secondary	Judgement of Line Orientation	Cognitive test; Change pre- to post-test between groups	7 months
Secondary	Controlled Oral Word Association Test	Cognitive test; Change pre- to post-test between groups	7 months
Secondary	California Verbal Learning Test	Cognitive test; Change pre- to post-test between groups	7 months
Secondary	Brief Visual Memory Test	Cognitive test; Change pre- to post-test between groups	7 months
Secondary	Delis-Kaplan Executive Function System Sorting Test	Cognitive test; Change pre- to post-test between groups	7 months
Secondary	Beck Depression Inventory - Fast Screen	Non-cognitive Questionnaire; Change pre- to post-test between groups	7 months
Secondary	Hospital Anxiety and Depression Scale	Non-cognitive Questionnaire; Change pre- to post-test between groups	7 months
Secondary	Fatigue Severity Scale	Non-cognitive Questionnaire; Change pre- to post-test between groups	7 months
Secondary	Short Form Health Survey	Non-cognitive Questionnaire; Change pre- to post-test between groups	7 months
Secondary	Dysexecutive Questionnaire	Non-cognitive Questionnaire; Change pre- to post-test between groups in terms of the amount of self-reported issues with executive functions.	7 months
Secondary	Cognitive Failures Questionnaire	Non-cognitive Questionnaire; Change pre- to post-test between groups in terms of the amount of self-reported cognitive issues	7 months
Secondary	BRIEF Cope	Non-cognitive Questionnaire; Change pre- to post-test between groups	7 months
Secondary	Social Stress and Support Interview	Non-cognitive Questionnaire; Change pre- to post-test between groups	7 months
Secondary	Multiple Sclerosis Neuropsychological Screening Questionnaire	Non-cognitive Questionnaire; Change pre- to post-test between groups	7 months
Secondary	Perceived Deficits Questionnaire	Non-cognitive Questionnaire; Change pre- to post-test between groups	7 months
Secondary	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.	7 months
Secondary	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.	7 months
Secondary	Arithmetic	Cognitive Test; Change pre- to post-test between groups, elementary math presented and solved without a pencil and paper.	7 months
Secondary	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.	7 months