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A global post approval study to collect safety and effectiveness data related to ExAblate Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement Disorders, or Neuropathic Pain within the thalamus and/or pallidum.
A global, multi-center, open-label, observational registry to capture safety and effectiveness data related to ExAblate Neuro, an MRI guided focused ultrasound device designed to lesion tissue deep within the brain using sound waves without the need for craniotomy. This registry includes certain regional and country specific approved thalamotomy and pallidotomy procedures using ExAblate Neuro for the treatment of various neurologic disorders such as essential tremor, Parkinson's movement disorders, and neuropathic pain. Treatment targets/indications are country/region dependent based on approved labeling within that region.
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Rating Scale for Tremor | CRST | 5 year |
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Inclusion Criteria:
Exclusion Criteria:
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Any patients suffering from clinically diagnosed neurologic disorders that can be
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| Name | Affiliation | Role |
|---|---|---|
| Howard Eisenberg, MD | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| University of Maryland |
Data will be shared via request from the publication committee. Active site participants will have access; however, it has not been decided when or if data will be shared with researchers not participating on this registry.
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| Baltimore |
| Maryland |
| 21201 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19106 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Swedish Neuroscience Institute | Seattle | Washington | 98122 | United States |
| Sunnybrook | Toronto | Ontario | M4N 3M5 | Canada |
| Rambam Healthcare Campus | Haifa | Israel |
| Sheba Medical Center | Ramat Gan | Israel |
| Chang Bing Show Chwan Memorial Hospital | Chang-hua | 505 | Taiwan |
| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| D010300 | Parkinson Disease |
| D009069 | Movement Disorders |
| D009437 | Neuralgia |
| D014202 | Tremor |
| D010146 | Pain |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020820 | Dyskinesias |
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