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The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.
This is a post-approval registry which is required by of the approval under PMA P150038/S006 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral thalamotomy in the treatment of medication refractory Tremor Dominant Parkinson's Disease (TDPD). Subjects participating in this registry will have received a unilateral thalamotomy (ventralis medius) prior to enrollment using the commercially available Exablate Neuro for the treatment of Essential tremor and TDPD.
The following assessments will be collected at Baseline,1, 3, 6, and 12 months post Exablate procedure and annually thereafter for 5 years:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post Exablate Neuro Thalamotomy for Tremor Associated with Tremor Dominant Parkinson's Disease | This is a post Exablate Neuro Thalamotomy registry. No intervention is performed under this registry protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unilateral thalamotomy | Device | Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term adverse events. | This registry will collect the long-term safety data after performing thalamotomy for TDPD using the Exablate Neuro system. | Five years. |
| Measure | Description | Time Frame |
|---|---|---|
| Tremor/motor intensity and impact on disability | Long term tremor motor scores and the impact of tremor on disability will be monitored using components of the Clinical Rating Scale for Tremor (CRST) | Five years. |
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Inclusion Criteria:
Exclusion Criteria:
Subject does not agree to participate or is unlikely to participate for the entirety of the study.
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The patient population enrolled in this registry will be comprised of male and female patients that plan to be treated for TDPD using the Exablate Neuro system.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matt Hibert | Contact | 214-630-2000 | clinicalresearchquestions@insightec.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Neuroscience Institute Baptist Health | Recruiting | Miami | Florida | 33176 | United States |
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| Rush University | Recruiting | Chicago | Illinois | 60612 | United States |
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| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Weill Cornell Medicine | Recruiting | New York | New York | 10065 | United States |
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| Novant Health Brain & Spine Surgery | Recruiting | Huntsville | North Carolina | 28708 | United States |
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| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Miami Valley Hospital | Recruiting | Fairborn | Ohio | 45324 | United States |
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| University of Dundee | Recruiting | Dundee | Scotland | DD1 9SY | United Kingdom |
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