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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cogmed Working Memory Training (CWMT)
Sponsored by
London Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as Usual

Training Group

Arm Description

This group will not any training with the Cogmed training program.

This group will receive intervention with the Cogmed training program and coach over a period of 5 weeks.

Outcomes

Primary Outcome Measures

Paced Auditory Serial Addition Test
Cognitive test; Change pre- to post-test between groups
Symbol Digit Modalities Test
Cognitive test; Change pre- to post-test between groups
Stroop colour word test
Cognitive test; Change pre- to post-test between groups

Secondary Outcome Measures

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

Full Information

First Posted
December 11, 2015
Last Updated
August 12, 2019
Sponsor
London Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02634567
Brief Title
Attention/Working Memory Rehabilitation in Multiple Sclerosis: A Pilot Project Using Cogmed Working Memory Training
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
London Health Sciences Centre

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
This group will not any training with the Cogmed training program.
Arm Title
Training Group
Arm Type
Experimental
Arm Description
This group will receive intervention with the Cogmed training program and coach over a period of 5 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cogmed Working Memory Training (CWMT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Paced Auditory Serial Addition Test
Description
Cognitive test; Change pre- to post-test between groups
Time Frame
7 months
Title
Symbol Digit Modalities Test
Description
Cognitive test; Change pre- to post-test between groups
Time Frame
7 months
Title
Stroop colour word test
Description
Cognitive test; Change pre- to post-test between groups
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Judgement of Line Orientation
Description
Cognitive test; Change pre- to post-test between groups
Time Frame
7 months
Title
Controlled Oral Word Association Test
Description
Cognitive test; Change pre- to post-test between groups
Time Frame
7 months
Title
California Verbal Learning Test
Description
Cognitive test; Change pre- to post-test between groups
Time Frame
7 months
Title
Brief Visual Memory Test
Description
Cognitive test; Change pre- to post-test between groups
Time Frame
7 months
Title
Delis-Kaplan Executive Function System Sorting Test
Description
Cognitive test; Change pre- to post-test between groups
Time Frame
7 months
Title
Beck Depression Inventory - Fast Screen
Description
Non-cognitive Questionnaire; Change pre- to post-test between groups
Time Frame
7 months
Title
Hospital Anxiety and Depression Scale
Description
Non-cognitive Questionnaire; Change pre- to post-test between groups
Time Frame
7 months
Title
Fatigue Severity Scale
Description
Non-cognitive Questionnaire; Change pre- to post-test between groups
Time Frame
7 months
Title
Short Form Health Survey
Description
Non-cognitive Questionnaire; Change pre- to post-test between groups
Time Frame
7 months
Title
Dysexecutive Questionnaire
Description
Non-cognitive Questionnaire; Change pre- to post-test between groups in terms of the amount of self-reported issues with executive functions.
Time Frame
7 months
Title
Cognitive Failures Questionnaire
Description
Non-cognitive Questionnaire; Change pre- to post-test between groups in terms of the amount of self-reported cognitive issues
Time Frame
7 months
Title
BRIEF Cope
Description
Non-cognitive Questionnaire; Change pre- to post-test between groups
Time Frame
7 months
Title
Social Stress and Support Interview
Description
Non-cognitive Questionnaire; Change pre- to post-test between groups
Time Frame
7 months
Title
Multiple Sclerosis Neuropsychological Screening Questionnaire
Description
Non-cognitive Questionnaire; Change pre- to post-test between groups
Time Frame
7 months
Title
Perceived Deficits Questionnaire
Description
Non-cognitive Questionnaire; Change pre- to post-test between groups
Time Frame
7 months
Title
Visual Spatial Span Board Assessment
Description
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.
Time Frame
7 months
Title
Digit Span
Description
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.
Time Frame
7 months
Title
Arithmetic
Description
Cognitive Test; Change pre- to post-test between groups, elementary math presented and solved without a pencil and paper.
Time Frame
7 months
Title
Letter-Number Sequencing
Description
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.
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah A Morrow, MD, MS, FRCPC (Neurology)
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

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

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