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:
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 50 is below the median of 96 across 1,085 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →InSightec is the lead sponsor of 84 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subject does not agree to participate or is unlikely to participate for the entirety of the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.