Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-29 @ 2:57 AM
Study NCT ID:
NCT05252195
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-27
First Post:
2022-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Detection and Prediction of Changes in Cognitive Function in Multiple Sclerosis (MS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2022-02-12', 'studyFirstSubmitQcDate': '2022-02-12', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cognitive Function - Ambulatory measurement via Dot Memory Test', 'timeFrame': 'Baseline up to year 2', 'description': 'Reported in terms of Euclidian distance/error\n\nCognition Covariates may include: age, sex, disease duration, Multiple Sclerosis (MS) subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary).'}, {'measure': 'Change in Cognitive Function - Ambulatory measurement via Symbol Search Test', 'timeFrame': 'Baseline up to year 2', 'description': 'Reported in Reaction Time (milliseconds)\n\nCognition Covariates may include: age, sex, disease duration, Multiple Sclerosis (MS) subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary).'}, {'measure': 'Change in Cognitive Function - clinic-based neurocognitive measurement via NIH Toolbox Cognitive Battery', 'timeFrame': 'Baseline up to year 2', 'description': 'Test Battery reported in T-scores. Covariates may include: age, sex, disease duration, MS subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary).'}, {'measure': 'Change in Cognitive Function - clinic-based neurocognitive measurement via Symbol Digit Modalities test', 'timeFrame': 'Baseline up to year 2', 'description': 'Covariates may include: age, sex, disease duration, MS subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary).\n\nThe score is the number of correct answers in 90 seconds. Higher scores indicates better attention and processing speed.'}, {'measure': 'Change in Cognitive Function - clinic-based neurocognitive measurement via Paced Auditory Serial Addition Test', 'timeFrame': 'Baseline up to year 2', 'description': 'Covariates may include: age, sex, disease duration, MS subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary).\n\nThe score range is 0-60 and higher numbers indicate better sustained attention, speed of information processing, and working memory.'}, {'measure': 'Change in Cognitive Function - clinic-based neurocognitive measurement via Rey Auditory Verbal Learning Test', 'timeFrame': 'Baseline up to year 2', 'description': 'Covariates may include: age, sex, disease duration, MS subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary).\n\nThe scores from the test represent the total immediate recall (over 5 learning trials), delayed recall, and recognition. Higher scores indicate better verbal learning and memory.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive dysfunction'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '39325510', 'type': 'DERIVED', 'citation': 'Kratz AL, Ehde DM, Alschuler KN, Pickup K, Ginell K, Fritz NE. Optimizing Detection and Prediction of Cognitive Function in Multiple Sclerosis With Ambulatory Cognitive Tests: Protocol for the Longitudinal Observational CogDetect-MS Study. JMIR Res Protoc. 2024 Sep 26;13:e59876. doi: 10.2196/59876.'}]}, 'descriptionModule': {'briefSummary': 'The researchers will use technology-assisted ambulatory assessment techniques to examine cognitive dysfunction in people with Multiple Sclerosis (MS).\n\nThe researchers will determine if ambulatory assessments are sensitive to subtle declines in cognitive functioning. They will also explore the impact of modifiable factors, such as sleep, physical activity, mood, and somatic symptoms on cognitive function. These efforts will uncover behavioral and medical intervention methods. Finally, they will explore whether variability in cognitive functioning predicts short- and long-term changes in other patient-centered functional domains, social participation and physical functioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants include a diverse sample of patients with MS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Are able to fluently converse and read in English.\n2. Multiple Sclerosis (MS) diagnosis (confirmed from neurologist, all relapsing and progressive subtypes included)\n3. Ambulate either independently or with the use of a cane or walker (or similar device) for at least 50% of the time at baseline\n\nExclusion Criteria:\n\n1. MS relapse within the past 30 days (may become eligible after 30 days; criteria used at T1, T2, and T3).\n2. Inability to use study data collection tools (i.e., ActiGraph wrist-worn activity watch, smart phone app).'}, 'identificationModule': {'nctId': 'NCT05252195', 'briefTitle': 'Optimizing Detection and Prediction of Changes in Cognitive Function in Multiple Sclerosis (MS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Optimizing Detection and Prediction of Changes in Cognitive Function in Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'HUM00199732'}, 'secondaryIdInfos': [{'id': '5R01HD102337-04', 'link': 'https://reporter.nih.gov/quickSearch/5R01HD102337-04', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants', 'description': 'Participants with Multiple Sclerosis who meet eligibility criteria.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Anna Kratz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Nora Fritz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'Wayne State University', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Physical Medicine and Rehabilitation', 'investigatorFullName': 'Anna Kratz', 'investigatorAffiliation': 'University of Michigan'}}}}