About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Unilateral thalamotomy
DeviceUnilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.
Treatment groups
Trial outcomes
Primary outcomes
Long-term adverse events.
This registry will collect the long-term safety data after performing thalamotomy for TDPD using the Exablate Neuro system.
Secondary outcomes
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)