NCT02634567

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

2.6 years

First QC Date

December 11, 2015

Last Update Submit

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 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.

Behavioral: Cogmed Working Memory Training (CWMT)

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.

Training Group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Sarah A Morrow, MD, MS, FRCPC (Neurology)

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

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

Locations