Attention/Working Memory Rehabilitation in Multiple Sclerosis: A Pilot Project Using Cogmed Working Memory Training
1 other identifier
interventional
31
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-sclerosis
Started Apr 2016
Typical duration for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2015
CompletedFirst Posted
Study publicly available on registry
December 18, 2015
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedAugust 13, 2019
August 1, 2019
2.6 years
December 11, 2015
August 12, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Paced Auditory Serial Addition Test
Cognitive test; Change pre- to post-test between groups
7 months
Symbol Digit Modalities Test
Cognitive test; Change pre- to post-test between groups
7 months
Stroop colour word test
Cognitive test; Change pre- to post-test between groups
7 months
Secondary Outcomes (19)
Judgement of Line Orientation
7 months
Controlled Oral Word Association Test
7 months
California Verbal Learning Test
7 months
Brief Visual Memory Test
7 months
Delis-Kaplan Executive Function System Sorting Test
7 months
- +14 more secondary outcomes
Study Arms (2)
Treatment as Usual
NO INTERVENTIONThis group will not any training with the Cogmed training program.
Training Group
EXPERIMENTALThis group will receive intervention with the Cogmed training program and coach over a period of 5 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah A Morrow, MD, MS, FRCPC (Neurology)
London Health Sciences Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MS, FRCPC (Neurology)
Study Record Dates
First Submitted
December 11, 2015
First Posted
December 18, 2015
Study Start
April 1, 2016
Primary Completion
November 1, 2018
Study Completion
December 1, 2018
Last Updated
August 13, 2019
Record last verified: 2019-08