Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-29 @ 3:07 AM
Study NCT ID:
NCT06272968
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2024-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Cognition After DBS for Parkinson's Disease 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2024-02-16', 'studyFirstSubmitQcDate': '2024-02-16', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cognitive performance after STN-DBS', 'timeFrame': 'Difference between baseline, 12 and 60 months postoperative testing', 'description': 'Based on cognitive screening by Cambridge CANTAB Connect'}, {'measure': 'Incidence of postoperative neurocognitive disorder', 'timeFrame': 'Difference between baseline, 12 and 60 months postoperative testing', 'description': 'Based on cognitive screening by paper pencil test (MoCA or MDRS)'}], 'secondaryOutcomes': [{'measure': 'Validation of post-hoc model from prior study (NCT03982953)', 'timeFrame': '1 year after DBS surgery', 'description': 'MoCA1yFU = 0.7 × MoCAbaseline + 1.7 × backward spanbaseline - 1, (see https://doi.org/10.1038/s41531-025-01128-3)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive Impairment', "Parkinson's disease", 'Deep Brain Stimulation', 'Postoperative Delirium'], 'conditions': ['Cognitive Impairment']}, 'descriptionModule': {'briefSummary': "The aim of the study is to improve estimation of cognitive outcome after STN-DBS in PD in order to avoid risk factors by optimizing peri- and intraoperative management personalize therapeutic strategies for optimal long-term benefit.\n\nThe investigators will test possible predictors (clinical, neuropsychological, neuroimaging, electrophysiological and molecular) for the risk of cognitive dysfunction after deep brain stimulation of the subthalamic nucleus (STN-DBS) in Parkinson's disease (PD) at a single center (Charité - Universitätsmedizin Berlin, Germany). Data collection takes place prior to as well as 3, 12 and 60 months after the STN-DBS operation. Participation is proposed to all PD patients that are planned to undergo STN-DBS after careful examination of eligibility for this treatment according to standard operation procedures.", 'detailedDescription': 'Additionally to clinical routine tests, the following possible predictors of cognitive dysfunction after STN-DBS in PD are investigated:\n\n* Imaging biomarkers: volume of the nucleus basalis of Meynert (NBM) measured on preoperative MRI and data driven search for unknown MRI characteristics relating to the incidence of postoperative neurocognitive disorder by means of Deep Learning (Convolutional Neural Networks), test of previously established classification models\n* Imaging neuronal glucose metabolism with \\[18F\\]-DG PET\n* Comorbidity: according to the Charlson Comorbidity Index\n* Nutritional Status: defined by the Mini Nutritional Assessment (MNA-SF)\n* Functional assessment of neuronal activity by 64-channel-EEG\n* Duration of intra-/perioperative brake of dopaminergic medication\n* Nature and depth of anaesthesia: general or conscious sedation and depth of consciousness: as measured by 4 channel electroencephalography (SedLine®) and during implantation of impulse generator\n* Incidence and duration of postoperative delirium: defined according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and/or as ≥ 2 points in the nursing Delirium Screening Scale (Nu-DESC) and/or a positive Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score, assessment three times daily during hospital stay\n* Length of stay at ICU / hospital\n* Postoperative organ complications: according to Clavien-Dindo classification Localisation of bilateral electrodes and active contacts on postoperative imaging\n\nSubstudies\n\nCorrelation of domain specific CANTAB connect test scores with possible predictors and incidence of postoperative neurocognitive disorder\n\nThe resulting multivariate risk model is expected\n\n* to improve peri- and intraoperative management by identifying avoidable risk factors for the development of postoperative cognitive deficit\n* to support evidence-based and personalized decision-making when advising PD patients considering STN-DBS\n* to result in the development of future hypothesis-driven interventional trials on the basis of biomarker-based sub-grouping of patients\n* to allow a better understanding of underlying pathophysiological processes both PD and surgery-related regarding cognitive effects of STN-DBS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'PD patients that are planned to undergo STN-DBS.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of idiopathic Parkinson's Disease\n* Indication for STN-DBS\n\nExclusion Criteria:\n\n* Internistic, surgical or psychiatric contrainidications with respect to the DBS operation or treatment for the STN-DBS group\n* Dementia\n* Relevant language barrier"}, 'identificationModule': {'nctId': 'NCT06272968', 'briefTitle': "Predicting Cognition After DBS for Parkinson's Disease 2", 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': "Predicting Cognition After DBS for Parkinson's Disease 2", 'orgStudyIdInfo': {'id': 'EA2/252/23'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Neuropsychological Testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Neuropsychological Testing via Cambridge CANTAB Connect'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13351', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Dorothee Kübler-Weller, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Movement Disorders and Neuromodulation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Senior Physician', 'investigatorFullName': 'Dorothee Kübler', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}