Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 4:37 AM
Study NCT ID:
NCT01772693
Status:
COMPLETED
Last Update Posted:
2020-10-09
First Post:
2012-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nadira@insightec.com', 'phone': '214-630-2000', 'title': 'Nadir Alikacem, Ph.D., VP Clinical Research', 'organization': 'Insightec'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This is a feasibility trial with no pre-defined hypothesis testing. It is primarily a safety trial with a secondary objective of collecting efficacy outcomes for developing future pivotal trials.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'ExAblate Transcranial MRgFUS', 'description': 'ExAblate Transcranial MR guided Focused Ultrasound\n\nExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Sham ExAblate Transcranial MRgFUS', 'description': 'Sham treatment with ExAblate MR guided Focused Ultrasound\n\nSham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Sleep Disorder', 'notes': "Related to Parkinson's Disease progression.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgnosia', 'notes': "Related to Parkinson's Disease progression", 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor worsened', 'notes': "Related to Parkinson's Disease progression", 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatique', 'notes': 'Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal weakness', 'notes': 'Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgnosia', 'notes': 'Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': 'Procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysmetria', 'notes': 'Thalamotomy related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gait disturbance', 'notes': 'Thalamotomy related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Thalamotomy related'}, {'term': 'Imbalance', 'notes': 'Thalamotomy related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysmetria', 'notes': 'Thalamotomy related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ataxia', 'notes': 'Thalamotomy related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Numbness/tingling', 'notes': 'Thalamotomy related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unsteady', 'notes': 'Thalamotomy related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'notes': 'Transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'notes': 'Transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sonication related flushing', 'notes': 'Transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual field defect', 'notes': 'Transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/Vomiting', 'notes': 'Transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Imbalance', 'notes': 'Transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Positional pain', 'notes': 'Transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Imbalance', 'notes': 'Transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'notes': 'Transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgnosia', 'notes': 'Transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Numbness/tingling', 'notes': 'Transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sonication related scalp pain', 'notes': 'Transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sonication related head pain', 'notes': 'Transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pin Site Pain', 'notes': 'Transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': 'Transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pigment change in eye', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vision change', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach pain', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vocal change', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening depression', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal weakness', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal pain', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Positional pain', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebelar infarct', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient Ischemic Attack', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Facial edema', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pin site numbness/tingling', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pin site pain', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stereotactic frame bruising', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hemiparesis', 'notes': 'After Focused Ultrasound Surgery thalamotomy procedure. Determined event to be SAE related to thalamotomy.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ataxia', 'notes': 'Event 1 component was mild right-sided hemiparesis (weakness) with drift. Event expected and related to thalamotomy. Resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'notes': 'Unrelated to device or procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Degenerative knee disease', 'notes': 'Unrelated to device or procedure. Subject had knee replacement and physical therapy. Adverse event resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening depression', 'notes': 'Since his tremor was gone he stopped his dopamine antagonist and he also stopped his antidepressants. His physicians planned to re-instate antidepressant medications and neuropsychology treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient ischemic attack', 'notes': "The Data Safety Monitoring Board discussed the event, the subject's symptoms and the lack of imaging findings and determined that they agreed with the investigator that this event was Unrelated to the Exablate procedure.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ExAblate Transcranial MRgFUS', 'description': 'ExAblate Transcranial MR guided Focused Ultrasound\n\nExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound'}, {'id': 'OG001', 'title': 'Sham ExAblate Transcranial MRgFUS', 'description': 'Sham treatment with ExAblate MR guided Focused Ultrasound\n\nSham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3', 'description': 'Evaluate of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor-dominant PD during the ExAblate treatment.\n\nPrimary safety analyses are reported in the adverse events module.', 'unitOfMeasure': 'Number of Adverse Events', 'reportingStatus': 'POSTED', 'populationDescription': 'All Adverse Events are reported in the Adverse Events module.'}, {'type': 'SECONDARY', 'title': 'Tremor Motor Score Percent Change From Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ExAblate Transcranial MRgFUS', 'description': 'ExAblate Transcranial MR guided Focused Ultrasound\n\nExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound'}, {'id': 'OG001', 'title': 'Sham ExAblate Transcranial MRgFUS', 'description': 'Sham treatment with ExAblate MR guided Focused Ultrasound\n\nSham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound'}], 'classes': [{'categories': [{'measurements': [{'value': '51.9', 'spread': '33.4', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '25.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3', 'description': "The percent change from baseline to Month 3 follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that was used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and 3 Months were used to calculate percent change from baseline and averaged across subjects. High percent change from baseline is better (shows improvement).", 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tremor Motor Scores - Clinical Rating Scale for Tremor - Treated Side Upper Extremity Parts A & B.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ExAblate Transcranial MRgFUS', 'description': 'ExAblate Transcranial MR guided Focused Ultrasound\n\nExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound'}, {'id': 'OG001', 'title': 'Sham ExAblate Transcranial MRgFUS', 'description': 'Sham treatment with ExAblate MR guided Focused Ultrasound\n\nSham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '19.0', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '20.1', 'spread': '7.4', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '9.6', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '17.4', 'spread': '7.8', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '10.5', 'spread': '10.2', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The sham ExAblate subjects exited the study at Month 3. The Exablate test subjects continued through Month 12.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 12', 'description': "Upper extremity Tremor-Motor score for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that measures treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points for each side with lower scores being a better outcome. Subject's Tremor-Motor scores for the test and sham control groups were averaged at each study visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Functional Disabilities - Clinical Rating Scale for Tremor Part C - Functional Disabilities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ExAblate Transcranial MRgFUS', 'description': 'ExAblate Transcranial MR guided Focused Ultrasound\n\nExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound'}, {'id': 'OG001', 'title': 'Sham ExAblate Transcranial MRgFUS', 'description': 'Sham treatment with ExAblate MR guided Focused Ultrasound\n\nSham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '14.1', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '16.7', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '6.4', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '6.9', 'spread': '7.2', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The Exablate sham subjects exited the study at the Month 3 study visit.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 12', 'description': 'The Clinical Rating Scale for Tremor (CRST) Part C is a measure of functional disability due to tremor. The Clinical Rating Scale for Tremor Part C consists of 8 items each scored from 0 to 4. Thus, the total score summed ranges from 0 to 32 and provides an overall assessment of activities of daily living. Low scores on the Clinical Rating Scale for Tremor (CRST) Part C are better. Low scores show improvement in functional disabilities compared to higher scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Exablate sham subjects exited the study at the Month 3 visit. The Exablate test subjects continued on through Month 12.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ExAblate Transcranial MRgFUS', 'description': 'ExAblate Transcranial MR guided Focused Ultrasound\n\nExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound'}, {'id': 'FG001', 'title': 'Sham ExAblate Transcranial MRgFUS', 'description': 'Sham treatment with ExAblate MR guided Focused Ultrasound\n\nSham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Health Concerns Unrelated to Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Alternative Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ExAblate Transcranial MRgFUS', 'description': 'ExAblate Transcranial MR guided Focused Ultrasound\n\nExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound'}, {'id': 'BG001', 'title': 'Sham ExAblate Transcranial MRgFUS', 'description': 'Sham treatment with ExAblate MR guided Focused Ultrasound\n\nSham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.9', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '62.9', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '66.6', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Clinical Rating Scale for Tremor - Treated Side', 'classes': [{'categories': [{'measurements': [{'value': '19.0', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '20.1', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '19.3', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline sum of upper extremity Tremor-Motor scores for the treated side from the Clinical Rating Scale for Tremor (CRST) Part A and Part B averaged across subjects. This measure of upper extremity tremor ranges from 0-32 with high scores being worse.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Mean Unified Parkinson's Disease Rating Scale (UPDRS) #20", 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '3.4', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '3.6', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Unified Parkinson's Disease Rating Scale (UPDRS) Question 20 is a measure of tremor of the treated side hand at rest on a score from 0 to 4 points. High scores are worse. Scores are averaged across subjects.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Mean Unified Parkinson's Disease Rating Scale (UPDRS) #21", 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '3.6', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '3.3', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Unified Parkinson's Disease Rating Scale (UPDRS) Question 21 is an assessment of action or postural tremor of the treated side hand scored from 0 to 4. High scores are worse. The scores are averaged across subjects.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single factor. ExAblate test verses ExAblate placebo randomized 2:1.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-17', 'studyFirstSubmitDate': '2012-11-28', 'resultsFirstSubmitDate': '2020-07-23', 'studyFirstSubmitQcDate': '2013-01-18', 'lastUpdatePostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-17', 'studyFirstPostDateStruct': {'date': '2013-01-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse Events', 'timeFrame': 'Month 3', 'description': 'Evaluate of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor-dominant PD during the ExAblate treatment.\n\nPrimary safety analyses are reported in the adverse events module.'}], 'secondaryOutcomes': [{'measure': 'Tremor Motor Score Percent Change From Baseline.', 'timeFrame': 'Baseline, Month 3', 'description': "The percent change from baseline to Month 3 follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that was used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and 3 Months were used to calculate percent change from baseline and averaged across subjects. High percent change from baseline is better (shows improvement)."}, {'measure': 'Tremor Motor Scores - Clinical Rating Scale for Tremor - Treated Side Upper Extremity Parts A & B.', 'timeFrame': 'Baseline, Month 3, Month 12', 'description': "Upper extremity Tremor-Motor score for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that measures treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points for each side with lower scores being a better outcome. Subject's Tremor-Motor scores for the test and sham control groups were averaged at each study visit."}, {'measure': 'Functional Disabilities - Clinical Rating Scale for Tremor Part C - Functional Disabilities', 'timeFrame': 'Baseline, Month 3, Month 12', 'description': 'The Clinical Rating Scale for Tremor (CRST) Part C is a measure of functional disability due to tremor. The Clinical Rating Scale for Tremor Part C consists of 8 items each scored from 0 to 4. Thus, the total score summed ranges from 0 to 32 and provides an overall assessment of activities of daily living. Low scores on the Clinical Rating Scale for Tremor (CRST) Part C are better. Low scores show improvement in functional disabilities compared to higher scores.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ExAblate Transcranial MRgFUS'], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '29084313', 'type': 'DERIVED', 'citation': 'Bond AE, Shah BB, Huss DS, Dallapiazza RF, Warren A, Harrison MB, Sperling SA, Wang XQ, Gwinn R, Witt J, Ro S, Elias WJ. Safety and Efficacy of Focused Ultrasound Thalamotomy for Patients With Medication-Refractory, Tremor-Dominant Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2017 Dec 1;74(12):1412-1418. doi: 10.1001/jamaneurol.2017.3098.'}]}, 'descriptionModule': {'briefSummary': 'This is a feasibility study to evaluate the safety and initial effectiveness of unilateral ExAblate thermal ablation of the Vim thalamic nucleus of subjects suffering from medication-refractory, idiopathic, tremor-dominant PD, using the ExAblate Transcranial system compared to a Sham Vim thalamotomy procedure.\n\nData will be collected to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy. The Sham treatment data will be used to evaluate placebo effect from treatment.', 'detailedDescription': "Subjects who sign informed consent and pass all eligibility criteria will be randomized to a treatment assignment. During treatment, the assigned treatment (ExAblate Transcranial or Sham ExAblate Transcranial)will be delivered. Subjects are followed in a blinded fashion for three (3) months. After the 3-month assessment, subjects will be unblinded and told their treatment assignment. Subjects receiving Sham ExAblate Transcranial treatment who still meet criteria will be crossed over and receive an active ExAblate Transcranial treatment. Subjects will be followed for up to two (2) years. Follow-up at 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and up to two (2) years includes Unified Parkinson's Disease Rating Scale (UPDRS) scoring, mental and cognitive functional testing and questionnaires."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women, age 30 years and older\n* Subjects who are able and willing to give informed consent and able to attend all study visits\n* Subjects with a diagnosis of idiopathic PD as confirmed from clinical history and examination by a movement disorder neurologist at the site\n* Subject demonstrates a severe resting tremor or postural/action as measured by UPDRS\n* Subject exhibits a significant disability from their PD tremor despite medical treatment\n* Subjects should be on a stable dose of all PD medications for 30 days prior to study entry\n* Subject is able to communicate sensations during the ExAblate Transcranial procedure\n\nExclusion Criteria:\n\n* Subjects with unstable cardiac status\n* Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse\n* Severe hypertension\n* Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.\n* Known intolerance or allergies to the MRI contrast agent including advanced kidney disease or severely impaired renal function\n* Significant claustrophobia that cannot be managed with mild medication\n* Current medical condition resulting in abnormal bleeding and/or coagulopathy\n* Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage\n* History of intracranial hemorrhage\n* History of multiple strokes, or a stroke within past 6 months\n* Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment\n* Are participating or have participated in another clinical trial in the last 30 days\n* Subjects unable to communicate with the investigator and staff\n* Subjects with a history of seizures within the past year\n* Subjects with brain tumors\n* Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment\n* Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia'}, 'identificationModule': {'nctId': 'NCT01772693', 'briefTitle': "ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'InSightec'}, 'officialTitle': "A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease.", 'orgStudyIdInfo': {'id': 'PD001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ExAblate Transcranial MRgFUS', 'description': 'ExAblate Transcranial MR guided Focused Ultrasound', 'interventionNames': ['Device: ExAblate Transcranial MRgFUS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham ExAblate Transcranial MRgFUS', 'description': 'Sham treatment with ExAblate MR guided Focused Ultrasound', 'interventionNames': ['Device: Sham ExAblate Transcranial MRgFUS']}], 'interventions': [{'name': 'ExAblate Transcranial MRgFUS', 'type': 'DEVICE', 'otherNames': ['ExAblate', 'MRgFUS', 'Focused Ultrasound', 'Transcranial MRgFUS Thalamotomy'], 'description': 'ExAblate Transcranial MR Guided Focused Ultrasound', 'armGroupLabels': ['ExAblate Transcranial MRgFUS']}, {'name': 'Sham ExAblate Transcranial MRgFUS', 'type': 'DEVICE', 'description': 'Sham ExAblate Transcranial MR Guided Focused Ultrasound', 'armGroupLabels': ['Sham ExAblate Transcranial MRgFUS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Jeff Elias, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InSightec', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}