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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

Who can join

Ages 30 to 99 · All sexes

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.

About the study

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.

What is being tested

• Unilateral thalamotomy (device)

Sponsor: InSightec · Participants: 50 · Started: Apr 28, 2022

Contact the study team

• Matt Hibert · Phone: 214-630-2000

Official record on ClinicalTrials.gov — NCT04991831

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.