Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-03-14 @ 5:51 AM
Study NCT ID:
NCT03723356
Status:
TERMINATED
Last Update Posted:
2021-03-26
First Post:
2018-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis (MS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D003072', 'term': 'Cognition Disorders'}], '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': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'due to low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-24', 'studyFirstSubmitDate': '2018-09-27', 'studyFirstSubmitQcDate': '2018-10-25', 'lastUpdatePostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)', 'timeFrame': 'Baseline', 'description': 'Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.'}, {'measure': 'intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)', 'timeFrame': '3 Months', 'description': 'Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.'}, {'measure': 'intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)', 'timeFrame': '6 Months', 'description': 'Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.'}, {'measure': 'intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)', 'timeFrame': '9 Months', 'description': 'Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.'}, {'measure': 'intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)', 'timeFrame': '12 Months', 'description': 'Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis', 'Cognition Disorders']}, 'descriptionModule': {'briefSummary': 'Multiple sclerosis (MS) is the most common progressive neurologic disorder to occur in adults of working-age. Despite longstanding recognition of cognitive impairment as a symptom of MS, two obstacles in measurement have limited understanding its biological basis, and therefore identifying targeted options for management. First is the absence of a sensitive and precise measure of cognitive impairment. Second is the absence of an index of disease status linked to brain pathophysiology and cognitive performance. This project overcomes both obstacles to link cognitive impairment to MS disease biomarkers. The absence of a sensitive and precise measure of cognitive impairment, along with the absence of an index of disease status linked to brain pathophysiology and cognitive performance, limits the understanding of the biological basis for multiple sclerosis (MS). This project overcomes both obstacles to link cognitive function to MS disease biomarkers, and provides preliminary evaluation of a disease modifying therapy (Tecfidera) for preserving cognitive function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '20 MS participants and 10 healthy controls. However, the data analysis is planned for 15 MS participants and 10 healthy control participants. It is expected that 15 MS subjects and 10 healthy controls will complete 12 months.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.\n2. Male and Female subjects between 18 and 45 years\n3. WRAT-4 Reading \\[127\\] standard score \\> 85\n4. Able to undergo neuroimaging data collection procedures. For MS Participants\n5. Definite diagnosis of RRMS \\[128\\]\n6. EDSS of 0 to 6.0\n7. Adequate vision as as reported by the participant (with correction if applicable)\n8. Clinically prescribed Tecfidera, Tysabri or Ocrevus therapy by treating neurologist, with first dose being within 3 months + 14 days from baseline visit\n9. At baseline visit, concurrent medications to be kept constant over three months prior to data collection visits\n10. No relapse or steroids in previous month\n\nExclusion Criteria:\n\n1. Unable or unwilling to provide informed consent.\n2. Beck Depression Inventory-Fast Screen (BDI-FS) \\[129, 130\\] score of 4 or more\n3. Current alcohol or other substance use disorder\n4. Primary psychiatric disorder that would adversely influence ability to participate\n5. Other neurological condition associated with cognitive impairment (e.g., epilepsy, brain injury)\n6. Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction)\n7. Learned English language after 12 years of age\n8. For low absolute low lymphocyte count (ALC), USPI guidance will be utilized.\n\n For MS participants:\n9. Lemtrada, Cladribine, Mitoxantrone'}, 'identificationModule': {'nctId': 'NCT03723356', 'briefTitle': 'Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis (MS)', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis', 'orgStudyIdInfo': {'id': '17-00238'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MS Patients', 'description': 'Definite diagnosis of RRMS', 'interventionNames': ['Diagnostic Test: Siemens Biograph mMR (molecular MR)', 'Diagnostic Test: fMRI', 'Diagnostic Test: Diffusion Spectrum Imaging (DSI)']}, {'label': 'Healthy Controls', 'description': 'gender aged match healthy', 'interventionNames': ['Diagnostic Test: Siemens Biograph mMR (molecular MR)', 'Diagnostic Test: fMRI', 'Diagnostic Test: Diffusion Spectrum Imaging (DSI)']}], 'interventions': [{'name': 'Siemens Biograph mMR (molecular MR)', 'type': 'DIAGNOSTIC_TEST', 'description': '5mCi of the radiotracer FDG administered intravenously as a bolus over 30s. After injection, emission data will be collected for 60 min,', 'armGroupLabels': ['Healthy Controls', 'MS Patients']}, {'name': 'fMRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'High-resolution T1-weighted structural image will be acquired using an MP2RAGE sequence. Subject will beasked to look at the cross hair on a screen andnot fixate on any one thought.', 'armGroupLabels': ['Healthy Controls', 'MS Patients']}, {'name': 'Diffusion Spectrum Imaging (DSI)', 'type': 'DIAGNOSTIC_TEST', 'description': 'DSI allows for more accurate characterization of diffusion,overcomes traditional dMRI artifacts, and is capable of more precise and detailedcharacterization of white matter fibers', 'armGroupLabels': ['Healthy Controls', 'MS Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Leigh Charvet', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': 'Beginning 3 months and ending 5 years following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'Researchers who provide a methodologically sound proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}