Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT05003206
Status:
UNKNOWN
Last Update Posted:
2021-08-12
First Post:
2021-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Value of Multimodal MRI 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046690', 'term': 'Deep Brain Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-10', 'studyFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2021-08-10', 'lastUpdatePostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical characteristics of patients', 'timeFrame': '1 to 2 years', 'description': 'Age at onset; age at surgery; disease duration; level of education; comorbidities (e.g. hypertension and diabetes mellitus); parkinsonism subtype; period of motor fluctuations; time from motor fluctuations to surgery; cigarette smoking'}, {'measure': 'Percentage of improvement in motor aspects (after 12 months of stimulation)', 'timeFrame': '1 to 3 years', 'description': '(UPDRS III 12 months - UPDRS III baseline)/UPDRS III baseline where UPDRS III 12 months means the score of this test in "medication off , stimulation on" condition at 12 months after implant, while UPDRS III baseline means the score of this test in "medication off " condition.The clinical outcome, or degree of symptom benefit, was defined as a ≥50% improvement on a disease severity rating scale'}], 'secondaryOutcomes': [{'measure': 'other records:', 'timeFrame': '1 to 3 years', 'description': 'Changes in type, dose and mode of use of drugs. Daily equivalent dose of levodopa (tomlinson2010 conversion)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Subthalamic nucleus deep brain stimulation'], 'conditions': ["Parkinson's Disease", 'Magnetic Resonance Imaging', 'Deep Brain Stimulation']}, 'descriptionModule': {'briefSummary': "Deep brain stimulation (DBS) is recognized as the most safe and effective neurosurgical method for the treatment of advanced Parkinson's disease. However, the mechanism of relieving motor and non-motor symptoms of Parkinson's disease has not been fully clarified, and the prognosis is significantly different. This study is based on multimodal MRI technique to clarify the mechanism of DBS in relieving motor and non-motor symptoms of Parkinson's disease, and to explore imaging indicators that can predict prognosis, so as to guide the individual and accurate treatment of Parkinson's disease (PD).", 'detailedDescription': "1. Preoperative and postoperative multimodal MRI scanning 1) equipment: 3TGE 750 MRI 2) sequence: resting state fMRI, DTI, 3DTI, ESWAN, ASL 3) scan status: drug shutdown period ( discontinuation of drugs for Parkinson's disease for at least 12 hours), for patients who can not adhere to MRI scanning after drug withdrawal. Record the dosage of drugs before scanning\n2. Evaluation of motor and non-motor symptoms: pre-operation and 1-year post-operation 1) motor symptoms: pre-operation medication opening and closing period. Postoperative medication off/stimulation off (Med-OFF/DBS-OFF);Med-ON/DBS-OFF;Med-OFF/DBS-ON;Med-ON/DBS-ON\n\n 1. overall evaluation of motor function: MDS-UPRDS, H\\&Y stage\n 2. balance: Berg balance scale\n 3. dyskinesia: abnormal involuntary movement scale(AIMS)\n 4. end-of-dose phenomenon: WOQ19 end-of-dose phenomenon questionnaire\n 5. daily activity ability: SCHWAB\\&ENGLAND daily activity scale 2) non-motor symptoms: preoperative drug shutdown period. Postoperative drug shutdown / DBS opening\n\n <!-- -->\n\n 1. Cognitive function: Mini Mental State Examination scale (MMSE), Montreal Cognitive Assessment scale (MoCA)\n 2. emotion: Hamilton Depression scale (HAMD), Hamilton anxiety scale (HAMA)\n 3. Sleep: PD Sleep scale (PDSS), Appleworth sleepiness scale (ESS), REM Sleep Behavioral Disorder questionnaire-Hong Kong (RBDQ-HK)\n 4. pain: King Parkinson's disease pain scale (KPPS)\n 5. fatigue: fatigue severity scale (FSS)\n 6. autonomic nervous function assessment: autonomic nervous scale (SCOPA-AUT) h) quality of life: 39 items Parkinson's disease quality of life questionnaire (PDQ-39) 3.other records: changes in type, dose and mode of use of drugs. Daily equivalent dose of levodopa (tomlinson2010 conversion)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient with Parkinson's disease\n* age\\< 70 years\n* Underwent bilateral STN-DBS or not\n* Having complete medical history and clinical follow up\n* All MRI examination performed according to study protocol\n* Imaging data can be processed\n* Signed informed consent obtained from the patient or patient's legally authorized representative;\n\nExclusion Criteria:\n\n* Parkinson-plus syndrome or secondary parkinsonism\n* Patients with severe mental disorders such as psychosis, liver and kidney dysfunction, poor blood pressure or blood glucose control, severe depression and substance abuse, low IQ, and acute phase of severe stroke with definite limb dysfunction should also be excluded."}, 'identificationModule': {'nctId': 'NCT05003206', 'briefTitle': "Predictive Value of Multimodal MRI in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': "Multimodal Magnetic Resonance Imaging Studying the Mechanism and Predicting the Outcome After Deep Brain Stimulation in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'Multimodal MRI DBS-PD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PD,DBS', 'description': 'Patients with idiopathic PD before and after DBS surgery', 'interventionNames': ['Other: Functional magnetic resonance imaging', 'Device: Deep Brain Stimulation']}], 'interventions': [{'name': 'Functional magnetic resonance imaging', 'type': 'OTHER', 'description': 'Preoperative and postoperative functional magnetic resonance imaging (fMRI) scanning. fMRI is a new neuroimaging method. Its principle is to use magnetic resonance imaging to measure the changes of hemodynamics caused by neuronal activity.', 'armGroupLabels': ['PD,DBS']}, {'name': 'Deep Brain Stimulation', 'type': 'DEVICE', 'description': 'For PD patients treated with DBS, the neurologist will turn off the stimulator before MRI scan', 'armGroupLabels': ['PD,DBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi-na Lan', 'role': 'CONTACT', 'email': 'lanyn1220@163.com', 'phone': '+86-17326826301'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yina Lan', 'role': 'CONTACT', 'email': 'lanyn1220@163.com', 'phone': '+86-17326826301'}], 'overallOfficials': [{'name': 'Xin Lou', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of Department of Radiology', 'investigatorFullName': 'Xin Lou', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}