Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2026-01-01 @ 5:07 AM
Study NCT ID:
NCT04573712
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2020-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Apathy on Different Forms of Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053609', 'term': 'Lethargy'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2020-09-28', 'studyFirstSubmitQcDate': '2020-10-01', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison of Fatigue Severity Scale scores between apathetic and non-apathetic subjects.', 'timeFrame': 'at inclusion', 'description': 'the minimum score is 9 (worse outcome) and the maximum score is 63 (better outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Apathy', 'Fatigue']}, 'referencesModule': {'references': [{'pmid': '35608793', 'type': 'DERIVED', 'citation': 'Daumas L, Zory R, Robert P, Manera V. Apathetic patients with neurocognitive disorders are more fatigued and fatigable. Aging Clin Exp Res. 2022 Sep;34(9):2237-2241. doi: 10.1007/s40520-022-02146-4. Epub 2022 May 24.'}]}, 'descriptionModule': {'briefSummary': '60 participants with light neuro-cognitive disorders (30 apathetic, 30 non-apathetic) will be recruited from the CMRR (Centre Mémoire Ressources et Recherche) in Nice University Hospital and from the " Fragilily " Platform of the Nice University Hospital.\n\nAfter verification by the investigator, if they meet the inclusion criteria and sign the informed consent, participants will have to wear an actigraph for one week in order to measure their level of activity.\n\nAfterwards, participants will have to complete assessments and questionnaires to evaluate apathy (Apathy Motivation Index, Apathy Inventory), perceived fatigue (Fatigue Severity Scale, Borg scale), fatigability (6-min walking test, isometric strength test, double task), the stress level (Perceived Stress Scale) and depression (Geriatric Depression Scale).\n\nRegarding the activity level, they will also be asked to perform tasks to evaluate their kinematic movements( through an actigraph), and their particular sensitivity towards effort and reward (through serious game \'Tap-piscine\').\n\nThe total duration of the evaluation is a maximum of 2 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men or women aged between 65 and 85 years old coming for consultation at the RMC and the Fragility Platform\n* DSM-5 diagnosis: minor neurocognitive disorders\n* Subject must read and write in French.\n* Subject must be registered in the national social security scheme.\n* Ability to sign free and informed consent.\n\nFor the 'apathetic' group:\n\n\\- Presence of apathy/emotional symptoms: at least 2 criteria according to the diagnostic criteria for apathy and a score higher than 8.5 in the MBI affective dimension.\n\nFor the 'non-apathetic' group:\n\n\\- Absence of apathy/emotional symptoms: no criteria according to the diagnostic criteria for apathy and a score of less than 8.5 in the MBI affective dimension.\n\nExclusion Criteria:\n\n* Motor or sensory disabilities likely to interfere with the tests.\n* Presence of major psychiatric disorders (e.g., schizophrenia, major depressive episode, bipolar disorder)\n* Patient under guardianship, curatorship or under legal protection"}, 'identificationModule': {'nctId': 'NCT04573712', 'acronym': 'FAME1', 'briefTitle': 'The Effects of Apathy on Different Forms of Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'FAME 1: The Effects of Apathy on Different Forms of Fatigue', 'orgStudyIdInfo': {'id': '20-PP-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fatigue Severity Scale scores assessment', 'description': 'Fatigue Severity Scale scores assessment', 'interventionNames': ['Other: Follow up and Assessment']}], 'interventions': [{'name': 'Follow up and Assessment', 'type': 'OTHER', 'description': 'each patient should wear an actigraph during a week and will be do some tests during 2hours (6min walk, apathy inventory, fatigue severity scale etc...)', 'armGroupLabels': ['Fatigue Severity Scale scores assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Memoire Ressources et Recherche, CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Philippe ROBERT, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de NICE, Centre Mémoire Ressources et Recherches'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}