Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-04 @ 8:38 AM
Study NCT ID:
NCT02634567
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2015-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attention/Working Memory Rehabilitation in Multiple Sclerosis: A Pilot Project Using Cogmed Working Memory Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2015-12-11', 'studyFirstSubmitQcDate': '2015-12-15', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Paced Auditory Serial Addition Test', 'timeFrame': '7 months', 'description': 'Cognitive test; Change pre- to post-test between groups'}, {'measure': 'Symbol Digit Modalities Test', 'timeFrame': '7 months', 'description': 'Cognitive test; Change pre- to post-test between groups'}, {'measure': 'Stroop colour word test', 'timeFrame': '7 months', 'description': 'Cognitive test; Change pre- to post-test between groups'}], 'secondaryOutcomes': [{'measure': 'Judgement of Line Orientation', 'timeFrame': '7 months', 'description': 'Cognitive test; Change pre- to post-test between groups'}, {'measure': 'Controlled Oral Word Association Test', 'timeFrame': '7 months', 'description': 'Cognitive test; Change pre- to post-test between groups'}, {'measure': 'California Verbal Learning Test', 'timeFrame': '7 months', 'description': 'Cognitive test; Change pre- to post-test between groups'}, {'measure': 'Brief Visual Memory Test', 'timeFrame': '7 months', 'description': 'Cognitive test; Change pre- to post-test between groups'}, {'measure': 'Delis-Kaplan Executive Function System Sorting Test', 'timeFrame': '7 months', 'description': 'Cognitive test; Change pre- to post-test between groups'}, {'measure': 'Beck Depression Inventory - Fast Screen', 'timeFrame': '7 months', 'description': 'Non-cognitive Questionnaire; Change pre- to post-test between groups'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': '7 months', 'description': 'Non-cognitive Questionnaire; Change pre- to post-test between groups'}, {'measure': 'Fatigue Severity Scale', 'timeFrame': '7 months', 'description': 'Non-cognitive Questionnaire; Change pre- to post-test between groups'}, {'measure': 'Short Form Health Survey', 'timeFrame': '7 months', 'description': 'Non-cognitive Questionnaire; Change pre- to post-test between groups'}, {'measure': 'Dysexecutive Questionnaire', 'timeFrame': '7 months', 'description': 'Non-cognitive Questionnaire; Change pre- to post-test between groups in terms of the amount of self-reported issues with executive functions.'}, {'measure': 'Cognitive Failures Questionnaire', 'timeFrame': '7 months', 'description': 'Non-cognitive Questionnaire; Change pre- to post-test between groups in terms of the amount of self-reported cognitive issues'}, {'measure': 'BRIEF Cope', 'timeFrame': '7 months', 'description': 'Non-cognitive Questionnaire; Change pre- to post-test between groups'}, {'measure': 'Social Stress and Support Interview', 'timeFrame': '7 months', 'description': 'Non-cognitive Questionnaire; Change pre- to post-test between groups'}, {'measure': 'Multiple Sclerosis Neuropsychological Screening Questionnaire', 'timeFrame': '7 months', 'description': 'Non-cognitive Questionnaire; Change pre- to post-test between groups'}, {'measure': 'Perceived Deficits Questionnaire', 'timeFrame': '7 months', 'description': 'Non-cognitive Questionnaire; Change pre- to post-test between groups'}, {'measure': 'Visual Spatial Span Board Assessment', 'timeFrame': '7 months', '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.'}, {'measure': 'Digit Span', 'timeFrame': '7 months', '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.'}, {'measure': 'Arithmetic', 'timeFrame': '7 months', 'description': 'Cognitive Test; Change pre- to post-test between groups, elementary math presented and solved without a pencil and paper.'}, {'measure': 'Letter-Number Sequencing', 'timeFrame': '7 months', '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.'}]}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Gender Both: both female and male participants are being studied\n\nAge Limits Minimum Age: 18 years Maximum Age: 64 years\n\nAccepts Healthy Volunteers? No\n\nEligibility Criteria\n\nInclusion Criteria:\n\n* Males/Females, Ages 18-64, with any type of MS\n* Lower to moderate physical disability\n* 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)\n* Patients must have a Mac or personal computer (PC) computer at home with access to the internet\n\nExclusion Criteria:\n\n* Clinical relapse/steroid treatment 1 month prior to study entry\n* Physical disability that prevents completion of study measures or training\n* History of severe mental illness or daily marijuana use\n* Those who do not meet the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT02634567', 'briefTitle': 'Attention/Working Memory Rehabilitation in Multiple Sclerosis: A Pilot Project Using Cogmed Working Memory Training', 'organization': {'class': 'OTHER', 'fullName': 'London Health Sciences Centre'}, 'orgStudyIdInfo': {'id': '107343'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual', 'description': 'This group will not any training with the Cogmed training program.'}, {'type': 'EXPERIMENTAL', 'label': 'Training Group', 'description': 'This group will receive intervention with the Cogmed training program and coach over a period of 5 weeks.', 'interventionNames': ['Behavioral: Cogmed Working Memory Training (CWMT)']}], 'interventions': [{'name': 'Cogmed Working Memory Training (CWMT)', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Training Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Sarah A Morrow, MD, MS, FRCPC (Neurology)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London Health Sciences Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MS, FRCPC (Neurology)', 'investigatorFullName': 'Sarah Morrow', 'investigatorAffiliation': 'London Health Sciences Centre'}}}}