Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT05476302
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2022-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Remote Cognitive Intervention in Patients With Parkinson's Disease During the COVID-19 Pandemic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2022-07-22', 'studyFirstSubmitQcDate': '2022-07-26', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in cognitive status', 'timeFrame': 'This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)', 'description': 'The Mini Mental State Examination (MMSE) was used to evaluate the cognitive status.The test consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, sriting ability and reproduction of complex polygons); the total score can range from 0 to 30, with a higher score indicating better function.'}], 'secondaryOutcomes': [{'measure': 'changes in cognitive domains', 'timeFrame': 'This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)', 'description': "The Addembrooke's Cognitive Examination Battery (ACE-R) was used to evaluate the cognitive domains. The ACE-R consists of six components evaluating separate cognitive domains. A maximum score of 100 is weighted as follows: orientation (10), attention (8), memory(35), verbal fluency (14), language (28), and visuospatialability (5)."}, {'measure': 'changes in thymic state', 'timeFrame': 'This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)', 'description': 'The Geriatric Depression Scale-15 items (GDS-15 items) was used to evaluate the tymic state.This instrument evaluated depressive symptoms using yes/no answers. Scores range between 0 and 15 points. Higher scores indicate more severe depressive symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'cognitive telerehabilitation', "Parkinson's disease", 'Cognition'], 'conditions': ['Parkinson Disease', 'COVID-19', 'Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': "Retrospective study to evaluate the effect of a remote cognitive-rehabilitative intervention during the Covid outbreak in subjects with Parkinson's disease.", 'detailedDescription': "Mild cognitive impairment is frequent among people with Parkinson's disease. Cognitive training seems effective on cognitive status and for mitigating anxiety and depression. With COVID-19 outbreak, such therapeutic interventions were delivered online. This retrospective study was aimed at evaluating the effectiveness of an online cognitive treatment, carried out in COVID times and based on the Parkinson's-Adapted Cognitive Stimulation Therapy, on cognitive domains and mood in 18 older people with Parkinson's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Parkinson's disease that, after eight months of COVID-19 lockdown when all interventions were suspended, received an intensive digital cognitive rehabilitation treatment.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parkinson disease: Hoehn \\& Yahr's scale: 1-3 based on the UK PD Society Brain Bank\n* mild cognitive impairment\n* no cognitive training between March and October 2020\n* presence of a family caregiver to access and use the online platform\n\nExclusion Criteria:\n\n* other neurological diseases\n* deep brain stimulation\n* schizophrenia\n* depression\n* sensory deprivations that could interfere with the treatment"}, 'identificationModule': {'nctId': 'NCT05476302', 'acronym': 'TELEPARK', 'briefTitle': "Effect of Remote Cognitive Intervention in Patients With Parkinson's Disease During the COVID-19 Pandemic", 'organization': {'class': 'OTHER', 'fullName': 'Istituto Nazionale di Ricovero e Cura per Anziani'}, 'officialTitle': "Effect of Remote Cognitive Intervention in Patients With Parkinson's Disease During the COVID-19 Pandemic", 'orgStudyIdInfo': {'id': 'INRCA_004_2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cognitive digital treatment', 'description': "Cognitive digital treatment in patients with Parkinson's disease", 'interventionNames': ['Other: Cognitive digital treatment']}], 'interventions': [{'name': 'Cognitive digital treatment', 'type': 'OTHER', 'description': "The remote cognitive-rehabilitation treatment was based on Parkinson's adapted cognitive stimulation therapy (CST). Fourteen twice-weekly sessions were planned, followed by one session per week for a duration of six months for maintenance therapy. The treatment took place in groups of 4 patients in remote mode through the Microsoft-Teams platform. All subjects maintained the prescribed drug therapy and regular physiotherapy activity during the intervention.", 'armGroupLabels': ['Cognitive digital treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60127', 'city': 'Ancona', 'country': 'Italy', 'facility': 'IRCCS INRCA Hospital', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Nazionale di Ricovero e Cura per Anziani', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}