A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Unilateral thalamotomy.
- Who it may be relevant to
- Registry conditions: Tremor Associated With Tremor Dominant Parkinson's Disease. Basic parameters: 30 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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:
* Adverse Events (AEs) (does not apply to Baseline Visit) * Medication usage * Clinical Rating Scale for Tremor (CRST) ON medication * Unified Parkinson's Disease Rating Scale Part III ON medication * EQ-5D-5L * WPAI-GH
Interventions
- Device Unilateral thalamotomy
Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.
Primary outcome measures
- Long-term adverse events. [Time frame: Five years.]
Secondary outcome measures (1)
- Tremor/motor intensity and impact on disability [Time frame: Five years.]
Eligibility criteria
Inclusion criteria
- Men and women, age 30 years and older
- Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution standard of care.
- Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits
- Subject has signed and received a copy of the approved informed consent form
Exclusion criteria
Subject does not agree to participate or is unlikely to participate for the entirety of the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 7 centers
- Miami Neuroscience Institute Baptist Health — Miami
- Rush University — Chicago
- Brigham and Women's Hospital — Boston
- Weill Cornell Medicine — New York
- Novant Health Brain & Spine Surgery — Huntsville
- Cleveland Clinic Foundation — Cleveland
- Miami Valley Hospital — Fairborn
United Kingdom · 1 center
- University of Dundee — Dundee
Identifiers
NCT: NCT04991831 · PD012