RecruitingNCT04991831

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


Sponsor

InSightec

Enrollment

50 participants

Start Date

Apr 28, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 30 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This is a registry (a type of observational study) that follows patients with Parkinson's disease who are being treated with a device called Exablate 4000, which uses focused ultrasound to treat tremors without surgery. It tracks long-term outcomes after this FDA-approved treatment. **You may be eligible if...** - You are 30 years or older - You are undergoing or have had the Exablate focused ultrasound procedure for tremor-dominant Parkinson's disease - You are willing to attend all registry follow-up visits - You have signed the informed consent form **You may NOT be eligible if...** - You are not willing or unlikely to participate for the full duration of the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEUnilateral thalamotomy

Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.


Locations(8)

Miami Neuroscience Institute Baptist Health

Miami, Florida, United States

Rush University

Chicago, Illinois, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Weill Cornell Medicine

New York, New York, United States

Novant Health Brain & Spine Surgery

Huntsville, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Miami Valley Hospital

Fairborn, Ohio, United States

University of Dundee

Dundee, Scotland, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04991831