Tremor Associated With Tremor Dominant Parkinson's Disease
Conditions
Brief summary
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
DEVICEUnilateral thalamotomy
Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.
Sponsors
InSightec
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women, age 30 years and older 2. Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution standard of care. 3. Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term adverse events. | Five years. | This registry will collect the long-term safety data after performing thalamotomy for TDPD using the Exablate Neuro system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tremor/motor intensity and impact on disability | Five years. | 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) |
Countries
United Kingdom, United States
Contacts
CONTACTMatt Hibert
Outcome results
None listed