Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-01-08 @ 1:00 AM
Study NCT ID:
NCT03206034
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2017-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stylistic Memory Enhancement
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blind placebo controlled randomized control trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-29', 'studyFirstSubmitDate': '2017-06-27', 'studyFirstSubmitQcDate': '2017-06-29', 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'California Verbal Learning Test (CVLT-II- Total learning', 'timeFrame': 'Baseline and post-intervention (5 weeks between testing sessions)', 'description': 'Measure of change in new learning'}], 'secondaryOutcomes': [{'measure': 'Memory Functioning Questionnaire', 'timeFrame': 'Baseline and post-intervention ( 5 weeks between testing sessions)', 'description': 'Measure of change in Self-report of everyday memory functioning'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Memory', 'Cognition'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Impairments in higher level cognitive processing, such as new learning and memory, are common in Multiple Sclerosis (MS) and negatively impact multiple aspects of everyday life, including occupational and social functioning. Despite this, few studies have attempted to remediate these cognitive deficits in order to improve everyday functioning. While not applied in traditional rehabilitation protocols as of yet, many techniques from cognitive psychology significantly improve learning and memory in healthy persons. These techniques include the generation effect (GE), the spacing effect (SE), and the testing effect (TE). These techniques have recently been incorporated into an 8-session treatment protocol, Stylistic Memory Enhancement (SME), designed to teach participants about each of the techniques, train them on how to apply the techniques in daily life and practice their application to daily life memory demanding situations. The protocol includes teaching participants how to restructure a memory demanding situation in order to make optimal use of self-generation, spaced learning and self-testing. The objective of the study is to test the efficacy of the SME in an MS population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinically definite MS between the ages of 18 and 59. Participants must have impairment in new learning (determined by an in-person screen) with intact language comprehension.\n\nExclusion Criteria:\n\n* History of alcohol or drug abuse/dependence,\n* Major psychiatric disturbance (e.g. bipolar disorder, schizophrenia) and neurological history other than MS.\n* Corticosteroid use within the last month prior to the participation.\n* Less than 1 month post most recent exacerbation.'}, 'identificationModule': {'nctId': 'NCT03206034', 'acronym': 'SME', 'briefTitle': 'Stylistic Memory Enhancement', 'organization': {'class': 'OTHER', 'fullName': 'Kessler Foundation'}, 'officialTitle': 'Stylistic Memory Enhancement', 'orgStudyIdInfo': {'id': 'E-769-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'The experimental group will meet with a study team member twice a week for 4 weeks (8 sessions) and receive memory strategy training.', 'interventionNames': ['Behavioral: Stylistic Memory Enhancement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'The control group participants will meet with a study team member twice a week for 4 weeks (8 sessions) and receive control memory exercises.', 'interventionNames': ['Behavioral: Stylistic Memory Enhancement']}], 'interventions': [{'name': 'Stylistic Memory Enhancement', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control', 'Treatment']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kessler Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Neuropsychology and Neuroscience Research', 'investigatorFullName': 'Nancy Chiaravalloti', 'investigatorAffiliation': 'Kessler Foundation'}}}}