Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-24 @ 9:52 PM
Study NCT ID:
NCT03300193
Status:
COMPLETED
Last Update Posted:
2017-10-03
First Post:
2016-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Lesion Characteristics in MRgFUS on Tremor in Essential Tremor and Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014202', 'term': 'Tremor'}, {'id': 'D020329', 'term': 'Essential Tremor'}, {'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-27', 'studyFirstSubmitDate': '2016-05-29', 'studyFirstSubmitQcDate': '2017-09-27', 'lastUpdatePostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'adverse events of the MRgFUS', 'timeFrame': '3 MONTHS', 'description': 'Assessment of adverse events of the MRgFUS'}, {'measure': 'assessment of the location of lesion on MRI', 'timeFrame': '3 MONTHS', 'description': 'assessment of the location of the lesion in post procedure MRI'}, {'measure': 'Size of the lesion on MRI', 'timeFrame': '3 MONTHS', 'description': 'volume in mm3 of lesion in post procedure MRI'}, {'measure': 'Surrounding edema on MRI', 'timeFrame': '3 MONTHS', 'description': 'volume in mm3 of edema in post procedure MRI'}], 'primaryOutcomes': [{'measure': 'Clinical Rating Scale for Tremor', 'timeFrame': '3 MONTHS', 'description': 'Tremor score: In ET patients - Clinical Rating Scale for Tremor (CRST)'}, {'measure': 'Motor part of Unified PD Rating Scale', 'timeFrame': '3 MONTHS', 'description': 'In PD patients - Motor part of Unified PD Rating Scale (UPDRS)'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Essential Tremor Questionnaire', 'timeFrame': '3 MONTHS', 'description': 'Quality of life: Quality of Life Essential Tremor Questionnaire (QUEST)'}, {'measure': "Parkinson's Disease Questionnaire", 'timeFrame': '3 MONTHS', 'description': "Parkinson's Disease Questionnaire (PDQ39)"}, {'measure': 'iSeismometer application', 'timeFrame': '3 MONTHS', 'description': 'For all patients: iSeismometer application for mobile phone for Assessment of tremor amplitude and frequency before and after the procedure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Magnetic Resonance guided Focused Ultrasound', 'Tremor', 'Essential Tremor', "Parkinson's Disease"], 'conditions': ['Tremor']}, 'descriptionModule': {'briefSummary': "The study will investigate Essential Tremor and Parkinson's Disease patients who underwent Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS). We will evaluate the effect of lesion characteristics on tremor and on quality of life after the procedure as compared with the baseline prior to the procedure.", 'detailedDescription': "The purpose of the study is to investigate the effect of lesion characteristics in ExAblate Transcranial Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) of the Vim thalamic nucleus. Clinical measures will be used to study patients suffering from medication-refractory tremor, Essential Tremor or idiopathic Parkinson's Disease.\n\nThis study is designed as a prospective, observational, and clinical study. Assessments will be made before and after MRgFUS for; clinical tremor relief, quality of life (QoL) improvements, assessment of adverse events, and correlations of these measures with the size and shape of the lesion and the surrounding edema ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients which were diagnosed with ET or Idiopathic PD with medication refractory tremor that underwent MRgFUS procedure.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women, between 18 and 80 years.\n* Patients who underwent the MRgFUS procedure.\n* Patients who are able and willing to give consent and able to attend all study visits and Radiologic follow-up examination by MRI.\n* A diagnosis of ET or Idiopathic PD as confirmed from clinical history and examination preformed by a movement disorders neurologist.\n* ET patients: tremor severity score of greater than or equal to 2 in the treated hand/arm as measured by postural or action item on the Clinical Rating Scale for Tremor (CRST).\n* PD patients: tremor severity score of equal or greater than 3 on either item 20 or item 21 of motor part in the Unified PD Rating Scale (UPDRS).\n* Substantial disability in the performance of at least two daily activities from the disability subsection of the scales UPDRS for PD patients or CRST for ET patients.\n* The patient must have a history of an unsatisfactory response to medical management. All patients will need to have tried and failed at least one drug. Alternatively, a patient may also qualify if tremor-suppressing medications are contraindicated due to a coexisting medical condition or drug allergy.\n* Stable doses of all medications for 30 days prior to study entry.\n\nExclusion Criteria:\n\n* Patients which have not completed the MRgFUS procedure.\n* Patients which were diagnosed during the trial with additional diagnoses that can affect motor function, quality of life and symptoms of tremor.'}, 'identificationModule': {'nctId': 'NCT03300193', 'acronym': 'MRgFUS', 'briefTitle': "The Effect of Lesion Characteristics in MRgFUS on Tremor in Essential Tremor and Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': "The Effect of Lesion Characteristics in Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS) on Tremor in Essential Tremor and Parkinson's Disease", 'orgStudyIdInfo': {'id': '0162-15-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tremor patients', 'description': "Essential Tremor and Parkinson's Disease patients with Tremor refractory to pharmacological therapy who underwent Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS)"}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Menashe Zaaroor, MD, DSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Neurosurgical Department', 'investigatorFullName': 'Menashe Zaaroor, MD PhD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}