Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-27 @ 5:31 PM
Study NCT ID:
NCT03476668
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2018-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Dopaminergic Asymmetric Degeneration and Attentional Resources in Parkinson's Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-28', 'studyFirstSubmitDate': '2018-03-19', 'studyFirstSubmitQcDate': '2018-03-19', 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Reaction Times (V RTs)', 'timeFrame': '4 weeks', 'description': 'Visual Reaction Times'}, {'measure': 'Auditory Reaction Times (A RTs)', 'timeFrame': '4 weeks', 'description': 'Auditory Reaction Times'}, {'measure': 'Multiple Choices RTs (MC RTs)', 'timeFrame': '4 weeks', 'description': 'Multiple Choices RTs'}], 'secondaryOutcomes': [{'measure': "Unified Parkinson's Disease Rating Scale (UPDRS)", 'timeFrame': '4 weeks', 'description': "Unified Parkinson's Disease Rating Scale"}, {'measure': 'Timed Up and Go Test (TUG)', 'timeFrame': '4 weeks', 'description': 'Timed Up and Go Test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease', 'Attention Disturbances']}, 'descriptionModule': {'briefSummary': "The researchers aimed to investigate the relationship between the asymmetric dopaminergic degeneration and the attentional resources in a group of patients with Parkinson's disease (PD).", 'detailedDescription': "To bypass the impaired habitual motor-behavioural control, Parkinson's disease (PD) patients may exploit the network of goal-directed mode of action. The frontostriatal connections underline this functioning, that is based on attention. Since the cognitive processes are related with dopamine, the asymmetrical degeneration of the dopaminergic system affects differently the right side affected (RPD) and the left side affected (LPD) PD patients.\n\nThe aim of the study was to investigate the relationship between the asymmetric dopaminergic degeneration and the attentional resources in a group of patients with PD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage 2.5-3 according to the Hoehn and Yahr scale (H\\&Y);\n* Stable pharmacological treatment for the last 6 weeks before the enrolment and during the hospitalization;\n* Mini Mental State Examination (MMSE) ≥ 24;\n* No evidences of dysexecutive syndrome.\n\nExclusion Criteria:\n\n* Any focal brain lesion detected in brain imaging studies (CT or MRI) performed in the previous 12 months;\n* Drug-induced dyskinesias;\n* Disturbing resting and/or action tremor, corresponding to scores 2-4 in the specific items of UPDRS III;\n* Behavioral disturbances (evaluated with Neuropsychiatric Inventory);\n* Visual and auditory dysfunctions according to the general clinical evaluation and medical history;\n* Equivocal report about the side of disease onset or bilateral motor involvement.'}, 'identificationModule': {'nctId': 'NCT03476668', 'acronym': 'RTsAsMIRT', 'briefTitle': "Relationship Between Dopaminergic Asymmetric Degeneration and Attentional Resources in Parkinson's Disease.", 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Generale Di Zona Moriggia-Pelascini'}, 'officialTitle': "Relationship Between Dopaminergic Asymmetric Degeneration and Attentional Resources in Parkinson's Disease.", 'orgStudyIdInfo': {'id': 'MIRT-RTs-Laterality'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RPD PD patients', 'description': 'Right-side affected PD patients. Intervention: MIRT', 'interventionNames': ['Other: MIRT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LPD PD patients', 'description': 'Left-side affected (LPD) PD patients. Intervention: MIRT', 'interventionNames': ['Other: MIRT']}], 'interventions': [{'name': 'MIRT', 'type': 'OTHER', 'description': '4-week multidisciplinary intensive rehabilitation treatment', 'armGroupLabels': ['LPD PD patients', 'RPD PD patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Giuseppe Frazzitta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'epartment of Parkinson\'s disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Generale Di Zona Moriggia-Pelascini', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}