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

Launched by INSIGHTEC · Jul 28, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and effectiveness of a treatment called thalamotomy for people with tremor dominant Parkinson's Disease (TDPD). The treatment uses a specialized system called Exablate Neuro to help reduce tremors in patients who have not found relief with medication. The trial aims to gather important information about how well this treatment works over time.

To participate in the study, individuals need to be at least 30 years old and willing to undergo the Exablate procedure as part of their treatment plan. They should also be ready to follow the study requirements, which include attending all scheduled visits and signing a consent form. The trial is currently recruiting participants of all genders. If someone agrees to join, they can expect regular check-ins to monitor their progress and help researchers understand how the treatment is working for them.

Gender

ALL

Eligibility criteria

• 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.