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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.
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.
This 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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tremor patients | Essential Tremor and Parkinson's Disease patients with Tremor refractory to pharmacological therapy who underwent Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Rating Scale for Tremor | Tremor score: In ET patients - Clinical Rating Scale for Tremor (CRST) | 3 MONTHS |
| Motor part of Unified PD Rating Scale | In PD patients - Motor part of Unified PD Rating Scale (UPDRS) | 3 MONTHS |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Essential Tremor Questionnaire | Quality of life: Quality of Life Essential Tremor Questionnaire (QUEST) | 3 MONTHS |
| Parkinson's Disease Questionnaire | Parkinson's Disease Questionnaire (PDQ39) |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events of the MRgFUS | Assessment of adverse events of the MRgFUS | 3 MONTHS |
| assessment of the location of lesion on MRI | assessment of the location of the lesion in post procedure MRI |
Inclusion Criteria:
Exclusion Criteria:
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Patients which were diagnosed with ET or Idiopathic PD with medication refractory tremor that underwent MRgFUS procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Menashe Zaaroor, MD, DSc | Rambam Health Care Campus | Principal Investigator |
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IPD
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| ID | Term |
|---|---|
| D014202 | Tremor |
| D020329 | Essential Tremor |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| 3 MONTHS |
| iSeismometer application | For all patients: iSeismometer application for mobile phone for Assessment of tremor amplitude and frequency before and after the procedure. | 3 MONTHS |
| 3 MONTHS |
| Size of the lesion on MRI | volume in mm3 of lesion in post procedure MRI | 3 MONTHS |
| Surrounding edema on MRI | volume in mm3 of edema in post procedure MRI | 3 MONTHS |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |