Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 7:14 AM
Study NCT ID:
NCT01659593
Status:
UNKNOWN
Last Update Posted:
2016-03-08
First Post:
2012-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-07', 'studyFirstSubmitDate': '2012-08-06', 'studyFirstSubmitQcDate': '2012-08-07', 'lastUpdatePostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'cognitive function: verbal memory (SRT), visuospatial memory (10/36), verbal fluency (animal categories),empans, code ,DO80, cognitive complaint', 'timeFrame': '0-9 months'}], 'primaryOutcomes': [{'measure': 'cognitive function measured by SRT-List score', 'timeFrame': '0-9 months'}], 'secondaryOutcomes': [{'measure': 'quality of life measured by MusiQol', 'timeFrame': '0 -9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cognitive disorders', 'multiple sclerosis', 'neuropsychology'], 'conditions': ['Cognitive Disorders', 'Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Cognitive disorders are well-known in multiple sclerosis (MS), even in earlier stages of the disease. They effect personal life. Their management may be overlooked. The evidence-based program proposes exercises to both stimulate preserved functions and develop new abilities compensating for cognitive disabilities.\n\nAim of the study is to evaluate the efficiency of the remedial program (PROCOG-SEP) designed for MS patients, compared to an interactive discussion program(DISINT) 140 multiple sclerosis patients will be randomly assigned in one the program for 13 sessions over a 6-month period.\n\nMain outcome criteria is evolution of SRT-LIST before and after program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 ≤Aged ≤ 60 at baseline\n* Must be able to understand and read french language\n* Must sign the informed consent form\n* Must be affiliate to French social security\n* multiple sclerosis confirmed by Mac Donald criteria\n* EDSS ≤ 6.0 at baseline\n* Duration of multiple sclerosis ≤ 30 years at baseline\n* mild cognitive disorder ( at least 2 cognitive tasks, at most 5 )\n\nExclusion Criteria:\n\n* under legal protection\n* treatment by corticosteroids in the past 4 weeks\n* cognitive remedial program already done\n* neuropsychologic assessment in the past 2 months\n* having an other chronic disease\n* having an other neurologic disease\n* alcohol or drug addiction'}, 'identificationModule': {'nctId': 'NCT01659593', 'acronym': 'PROCOG-SEP', 'briefTitle': 'Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients. A Double Blind Randomized Multicenter Trial.', 'orgStudyIdInfo': {'id': 'PROCOG-SEP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'procog', 'description': 'cognitive remedial program 13 sessions over a 6-month period', 'interventionNames': ['Other: procog']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'DISINT', 'description': 'Interactive discussion program of 13 group sessions in a 6-month period', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'procog', 'type': 'OTHER', 'description': '3 to 5 people group program', 'armGroupLabels': ['procog']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['DISINT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc DEBOUVERIE, MD', 'role': 'CONTACT', 'email': 'm.debouverie@chu-nancy.fr', 'phone': '00 33 3 83 15 16 88'}, {'name': 'Marc Debouverie, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University hospital Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Marc DEBOUVERIE, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU NANCY'}, {'name': 'Eric BERGER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU DE BESANCON'}, {'name': 'Thibaut MOREAU, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire Dijon'}, {'name': 'Jérôme de Sèze, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de STRASBOURG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}