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.
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
At a glance
Conditions
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.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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.