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The purpose of this study is to see if the MR-guided focused ultrasound (MRgFUS) thalamotomy procedure can be performed on both sides of the brain safely and effectively to reduce bilateral tremor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exablate Secondary Procedure | Experimental | Thalamotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exablate Model 4000 Type 1.0/1.1 | Device | Exablate thalamotomy of non tremor dominant side of the brain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device and procedure related adverse events | rate of adverse events following the Exablate secondary procedure | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Stanford | California | 94305 | United States | ||
| University of Maryland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39073822 | Derived | Kaplitt MG, Krishna V, Eisenberg HM, Elias WJ, Ghanouni P, Baltuch GH, Rezai A, Halpern CH, Dalm B, Fishman PS, Buch VP, Moosa S, Sarva H, Murray AM. Safety and Efficacy of Staged, Bilateral Focused Ultrasound Thalamotomy in Essential Tremor: An Open-Label Clinical Trial. JAMA Neurol. 2024 Sep 1;81(9):939-946. doi: 10.1001/jamaneurol.2024.2295. |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Baltimore |
| Maryland |
| 21201 |
| United States |
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| The Ohio State University - Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| West Virginia University | Morgantown | West Virginia | 26505 | United States |