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
Recruiting now
Conditions studied: Tremor Associated With Tremor Dominant Parkinson's Disease
In brief
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.
Key facts
- Study ID
- NCT04991831
- Run by
- InSightec
- People needed
- 50
- Starts
- 2022-04-28
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-03-20
Who can join
Age: 30 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Subject does not agree to participate or is unlikely to participate for the entirety of the study.
Where it is running
- Miami Neuroscience Institute Baptist Health — Miami, Florida, United States (enrolling)
- Rush University — Chicago, Illinois, United States (enrolling)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
- Weill Cornell Medicine — New York, New York, United States (enrolling)
- Novant Health Brain & Spine Surgery — Huntsville, North Carolina, United States (enrolling)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
- Miami Valley Hospital — Fairborn, Ohio, United States (enrolling)
- University of Dundee — Dundee, Scotland, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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