Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-06 @ 6:15 PM
Study NCT ID:
NCT04996992
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-08-09
First Post:
2021-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRgFUS Pallidothalamic Tractotomy for Therapy-Resistant 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-31', 'studyFirstSubmitDate': '2021-07-31', 'studyFirstSubmitQcDate': '2021-07-31', 'lastUpdatePostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary efficacy outcome', 'timeFrame': '1 year', 'description': "The primary endpoints at 6 months and 1 year postoperatively were the Unified Parkinson's Disease Rating Scale (UPDRS) scores."}, {'measure': 'primary safety outcome', 'timeFrame': '1 year', 'description': 'Primary safety outcome was assessed by monitoring the incidence and severity of the procedure-related adverse events from the procedure through 1 year after treatment for all patients.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MR-guided focused ultrasound', 'pallidothalamic tractotomy'], 'conditions': ['Parkinson Disease', 'Magnetic Resonance Imaging']}, 'descriptionModule': {'briefSummary': "To investigate the neural mechanism of Magnetic resonance-guided focused ultrasound (MRgFUS) Pallidothalamic Tractotomy in Parkinson's disease through multi-model MRI, and identify imaging biomarkers for triaging candidates and predicting the clinical outcomes.\n\nParkinson's disease (PD) is the second most progressive neurodegenerative disease with many motor and non-motor symptoms, which brings heavy burden to the family and the society.\n\nMRgFUS pallidothalamic tractotomy allows to address all symptoms of PD without skull opening and with very limited tissue ablation, but with varying effectiveness. The unknown pathogenesis of PD has greatly contributed to this variance. Therefore, in order to optimize the clinical application of MRgFUS pallidothalamic tractotomy, it is important to reveal the pathogenesis of Parkinson's disease by using multiple modality MRI methods, and identify imaging biomarkers to triage suitable candidates and predict clinical outcomes.", 'detailedDescription': 'Treatment scheme:\n\nAll patients will first receive uni- or bilateral MRgFUS PTT. As to bilateral interventions, the second one will take place at least 6 months after the first PTT. Patients with unilateral intervention will be followed to 1 year. Patients with bilateral interventions will be followed to 1 year after the second intervention. Baseline clinical demographics, Unified Parkinson Disease Rating Scale (UPDRS), treatment parameters (energy, power, duration time, temperature, target location) , associated adverse effects were recorded.\n\nImaging protocols:\n\nT2; T2 Flair; DWI; ESWAN; MRS; 3D ASL 2.0s; 3D-T1; DTI; rs-functional MRI\n\nImaging evaluation:\n\n1. Lesion appearance and volume are measured by T2, T2 Flair, DWI, ESWAN, 3D-T1;\n2. ESWAN and MRS manifests the changes of iron deposition and metabolism, respectively;\n3. ASL shows regional cerebral blood flow associated with the procedure;\n4. DTI demonstrates the destruction of white matter integrity.\n5. Rs-functional MRI reflects alterations of resting-state brain activity.\n\nTreatment:\n\nMRgFUS pallidothalamic tractotomy\n\nFollow-up:\n\nMRI + clinical evaluation: Baseline, 3-day, 1-week, 1-month, 3-months, 6-months,12-months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Parkinson's disease", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Regardless of sex, aged 30 or above, hope to treat bilateral motor symptoms and receive the other side treatment plan at the 6th month;\n2. Subjects are able and willing to give informed consent and can participate in whole study visits;\n3. It was clinically diagnosed as Parkinson's disease and confirmed by functional neurosurgeons;\n4. The subjects should respond to levodopa;\n5. In the off-medication state, the subjects' MDS-UPDRS scores were 30 or more.\n\nExclusion Criteria:\n\n1. The subjects scored 3 or more in the pull-back test;\n2. Parkinson's disease symptoms were suspected as the side effects of antipsychotics;\n3. severe cognitive impairment confirmed by neuropsychologists;\n4. subjects with other neurodegenerative diseases;\n5. Subjects with unstable mental illness, defined as active, uncontrolled depression, schizophrenia, delusions, hallucinations or suicide intention;\n6. Pregnant or lactating women;\n7. Subjects with alcohol or drug abuse;\n8. Subjects with unstable heart condition or severe hypertension;\n9. Subjects with a history of abnormal bleeding or clotting."}, 'identificationModule': {'nctId': 'NCT04996992', 'briefTitle': "MRgFUS Pallidothalamic Tractotomy for Therapy-Resistant Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': "Multimodal Magnetic Resonance Imaging Study for MRgFUS Pallidothalamic Tractotomy for Therapy-Resistant Parkinson's Disease", 'orgStudyIdInfo': {'id': 'MRgFUS-PTT-PD'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Parkinson's disease", 'description': "The cohort includes patients with Parkinson's disease who underwent MRgFUS pallidothalamic tractotomy (PTT).", 'interventionNames': ['Procedure: MR-guided focused ultrasound']}], 'interventions': [{'name': 'MR-guided focused ultrasound', 'type': 'PROCEDURE', 'description': "MR-guided focused ultrasound pallidothalamic tractotomy is a minimally invasive and effective procedure for thetreatment of Parkinson's disease(PD) patients.", 'armGroupLabels': ["Parkinson's disease"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Hao-xuan Lu', 'role': 'CONTACT', 'email': 'plaluhaoxuan@163.com', 'phone': '+86-13044270958'}, {'name': 'Xin Lou, MD', 'role': 'CONTACT'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hao-xuan Lu', 'role': 'CONTACT', 'email': 'plaluhaoxuan@163.com', 'phone': '+86-13044270958'}, {'name': 'Xin Lou, MD', 'role': 'CONTACT', 'phone': '+86-13044270958'}], 'overallOfficials': [{'name': 'Xin Lou, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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'}}}}