An observational study in Tremor Associated With Tremor Dominant Parkinson's Disease, sponsored by InSightec. Recruiting at 8 sites in 2 countries. Open to participants aged 30 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by InSightec · Observational
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:
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.
Exclusion Criteria:
Subject does not agree to participate or is unlikely to participate for the entirety of the study.
This is a post Exablate Neuro Thalamotomy registry. No intervention is performed under this registry protocol.
Device: Unilateral thalamotomy
Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.
Long-term adverse events.
This registry will collect the long-term safety data after performing thalamotomy for TDPD using the Exablate Neuro system.
Time frame: Five years.
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)
Time frame: Five years.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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