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
Tremor Associated With Tremor Dominant Parkinson's Disease
Investigational drug(s) / intervention(s)
Unilateral thalamotomy
Unilateral thalamotomy: Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.
Study 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.
Eligibility
Sex
ALL
Min age
30 Years
Max age
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.
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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