Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT05752656
Status:
RECRUITING
Last Update Posted:
2023-03-03
First Post:
2023-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short- and Long-term Behavioral, Cognitive and Motor Outcomes of Frameless Deep Brain Stimulation in Patients With Parkinson's Disease: a Prospective Observational Study
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'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2034-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-21', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-02-21', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of quality of life', 'timeFrame': 'One year', 'description': 'Evaluation of the PDQ-39 scale score at baseline (before surgery) and one year after surgery.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to evaluate the improvement in quality of life after deep brain stimulation surgery with frameless technique by comparing the PDQ-39 scale score at baseline (before surgery) and one year after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients affected by Parkinson's disease and candidates to intervention of deep brain stimulation.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of idiopathic Parkinson\'s disease according to Movement Disorder Society (MDS) criteria;\n* patients who are candidates for deep brain stimulation intervention, according to the international criteria of the "Core assessment program for surgical interventional therapies in Parkinson\'s disease" (CAPSIT-PD).\n\nExclusion Criteria:\n\n\\- patients unable to give informed consent.'}, 'identificationModule': {'nctId': 'NCT05752656', 'briefTitle': "Short- and Long-term Behavioral, Cognitive and Motor Outcomes of Frameless Deep Brain Stimulation in Patients With Parkinson's Disease: a Prospective Observational Study", 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': "Short- and Long-term Behavioral, Cognitive and Motor Outcomes of Frameless Deep Brain Stimulation in Patients With Parkinson's Disease: a Prospective Observational Study", 'orgStudyIdInfo': {'id': '4578'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Clinical examinations', 'type': 'OTHER', 'description': 'Clinical examinations and administration of clinical scales'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Flavia Torlizzi', 'role': 'CONTACT', 'email': 'flavia.torlizzi@policlinicogemelli.it', 'phone': '+390630156433'}], 'facility': 'Flavia Torlizzi', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Francesco Bove, MD', 'role': 'CONTACT', 'email': 'francesco.bove@policlinicogemelli.it', 'phone': '+390630156433'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}