Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-31 @ 12:37 PM
Study NCT ID:
NCT02670993
Status:
COMPLETED
Last Update Posted:
2016-09-20
First Post:
2016-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Support by Singing Sessions on Physical and Moral Pain : Assessment of Its Effectiveness in Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-19', 'studyFirstSubmitDate': '2016-01-25', 'studyFirstSubmitQcDate': '2016-01-28', 'lastUpdatePostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score at the EVS = simplified visual scale', 'timeFrame': 'Month 1', 'description': "To evaluate the efficacy of the singing sessions on pain in Alzheimer's Disease patients (beginning stage), by comparison with a control activity (painting), on pain intensity."}], 'secondaryOutcomes': [{'measure': 'Score at the EN (digital scale) scale', 'timeFrame': 'Month 1', 'description': "To evaluate the efficacy of the singing sessions on pain in Alzheimer's Disease patients (beginning stage), by comparison with a control activity (painting), on pain intensity."}, {'measure': 'Score at the BPI (Brief Pain Inventory) scale : Brief pain Inventory', 'timeFrame': 'Month 1', 'description': "To evaluate the efficacy of the singing sessions on pain in Alzheimer's Disease patients (beginning stage), by comparison with a control activity (painting), on pain intensity."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': 'Alzheimer Disease (AD), characterized by cognitive and psycho-behavioral troubles, concerns essentially 65 years old and older patients. Antalgic and psychotropic treatments have adverse effects in old people, and have to be used carefully. To improve the pain support and limit the drug consumption, it is possible to perform therapies without drugs. Among them, musical intervention represents an interesting complementary support, to deal with physical and moral pain in AD.', 'detailedDescription': 'Alzheimer Disease (AD), characterized by cognitive and psycho-behavioral troubles, concerns essentially 65 years old and older patients. At this age, comorbidities are frequent and numerous, and often linked to pain. The prevalence is comprised between 40 and 85% according to different studies. Antalgic and psychotropic treatments have adverse effects in old people, and have to be used carefully. To improve the pain support and limit the drug consumption, it is possible to perform therapies without drugs. Among them, musical intervention represents an interesting complementary support, to deal with physical and moral pain in AD.\n\nThe primary outcome is to evaluate the singing support on physical pain, by comparison with a control activity : "painting session".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients 60 years old and older, fulfilling the diagnostic criteria for Alzheimer's disease to a mild dementia stage, or mild cognitive impairment\n* Delay of at least one month between the diagnosis and the early work sessions\n* If use of psychotropic drugs, they must be stabilized for 3 month\n* If analgesics consumption level 2 or 3 they must be stabilized for 1 month\n* With a score greater than or equal to 22 on the simplified visual scale (EVS) pain.\n* Visual capabilities , auditory and oral or written expression in French language sufficient for conducting clinical and neuropsychological evaluations;\n* MMSE \\> 20\n* Patient affiliated or entitled to a social security scheme\n\nExclusion Criteria:\n\n* Patient with a different etiology of cognitive disorder that of Alzheimer's disease\n* Patients with severe disease, progressive or unstable nature which may interfere with the evaluation variables\n* Patient with blindness or deafness could compromise its assessment\n* Patient under guardianship"}, 'identificationModule': {'nctId': 'NCT02670993', 'acronym': 'LACME', 'briefTitle': "Support by Singing Sessions on Physical and Moral Pain : Assessment of Its Effectiveness in Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': "Support by Singing Sessions on Physical and Moral Pain : Assessment of Its Effectiveness in Alzheimer's Disease. Multicenter Study LACME", 'orgStudyIdInfo': {'id': '1508071'}, 'secondaryIdInfos': [{'id': '2015-A01404-45', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control group : Singing sessions.', 'description': 'Patients will participate to singing working sessions. They will continue to take their usual treatments during the study period.', 'interventionNames': ['Behavioral: Singing sessions.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group : Painting sessions.', 'description': 'Patients will continue to participate to painting work sessions, and to take their usual treatments during the study.', 'interventionNames': ['Behavioral: Painting sessions.']}], 'interventions': [{'name': 'Singing sessions.', 'type': 'BEHAVIORAL', 'description': 'Patients will be in singing work groups, and will participate to these sessions during 12 weeks, with one session per week of 2 hours.', 'armGroupLabels': ['Control group : Singing sessions.']}, {'name': 'Painting sessions.', 'type': 'BEHAVIORAL', 'description': 'Patients will be in painting groups, they will participate to this work session during 12 weeks, with one session of 2 hours per week.', 'armGroupLabels': ['Control group : Painting sessions.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69000', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '42100', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Chu Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'ROUCH Isabelle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}