Exablate Neuro for Tremor Dominant Parkinson's Disease

This study is a registry, which means it collects information from people who have already received a treatment called unilateral thalamotomy (a brain procedure) using the Exablate Neuro system. This treatment is for people with Parkinson's disease whose tremors are severe and don't respond to medication. The main goal is to see how safe and effective the Exablate Neuro system is over the long term. You can join if you are 30 years or older, have tremor-dominant Parkinson's disease, and are undergoing this specific Exablate procedure as part of your standard care. The study is looking for 50 participants, but the current recruitment status is not available.

Study design
This is an observational study, meaning researchers will collect information from 50 participants who have already received the treatment. It is a post-approval registry.
What's involved
You will have assessments at baseline, 1, 3, 6, and 12 months after your Exablate procedure, and then yearly for five years. These assessments include checking for side effects, medication use, and tremor and Parkinson's disease scales.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for five years to track long-term adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04991831

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
Not specifiedAges 30–99Observational
InSightec
~50 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:Unilateral thalamotomy

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Long-term adverse events.
Measured over Five years.
Tremor Associated With Tremor Dominant Parkinson's Disease

NCT04991831

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Brigham and Women's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohiostudy coordinator listed

    Recruiting

  • Miami Neuroscience Institute Baptist Health

    Miami, Floridastudy coordinator listed

    Recruiting

  • Miami Valley Hospital

    Fairborn, Ohiostudy coordinator listed

    Recruiting

  • Novant Health Brain & Spine Surgery

    Huntsville, North Carolinastudy coordinator listed

    Recruiting

  • Rush University

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • University of Dundee

    Dundee, Scotland, United Kingdomstudy coordinator listed

    Recruiting

  • Weill Cornell Medicine

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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  • 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.